4 the cycle of the supply of health products in brazil · 2021. 4. 5. · operation of import and...

2nd Edition

ABRAIDIBrazilian Association of Importers and

Distributors of Health Products

2019THE CYCLE

OF THE SUPPLY OF HEALTHPRODUCTS

IN BRAZIL

4 5THE CYCLE OF THE SUPPLY OF HEALTH PRODUCTS IN BRAZILTHE CYCLE OF THE SUPPLY OF HEALTH PRODUCTS IN BRAZIL

ADMINISTRATIVE COUNCIL

President Sérgio Dilamar Bitencourt da RochaENDOSUL COM. E REP. DE MAT. CIRÚRGICOS LTDA./RS

Vice president Gláucio Pegurin Libório ORTHOHEAD INSTR. E IMPL. CIRÚRGICOS LTDA./ES

Director Ronaldo Sampaio Carneiro DUDER PRODUTOS MÉDICOS LTDA./BA

CounselorsCândida de Fátima Bollis SP INTERVENTION LTDA./SP

Cassius Maggioni CORTICAL COMÉRCIO DE PRODUTOS CIRÚRGICOS LTDA./SP

Eduardo Ferreira Simões IMPLAMED IMPLANTES ESP. COM. IMPOR. EXP. LTDA./SP

Eduardo Sanchez Facci ORTHOMAXX HOSPITALAR EIRELI/SP

Fábio Almeida Bastos EMILCARDIO PRODUTOS HOSPITALARES EIRELI/ES

Gil Clemente de Magalhães Pinho MEDARTIS IMPORTAÇÃO E EXPORTAÇÃO LTDA./SP

Maria Cecilia Patrícia Braga Braile Verdi BRAILE BIOMÉDICA IND. COM. E REPRESENTAÇÕES LTDA./SP

Roberley Carlos Polycarpo UL QUÍMICA E CIENTÍFICA LTDA./ES

Silvio TsukudaLIVANOVA BRASIL COM. E DIST. DE EQUIP. MED. HOSP. LTDA./SP

GovernancePeriod2017–2020

AUDIT BOARD

CounselorsFernando Reatto CIENLABOR INDÚSTRIA E COMÉRCIO LTDA./PB

Josevaldo Nergino de Sousa LITORMED COMÉRCIO DE PRODUTOS MÉDICOS LTDA./CE

Ronaldo Sampaio Carneiro DUDER PRODUTOS MÉDICOS LTDA./BA

ETHICS AND PROCESSING COMMITTEE

PresidentVolnei Luiz Ortigara CANADÁ CENTRAL DE NEGÓCIOS DO BRASIL LTDA./RS

Vice presidentGil Clemente de Magalhães Pinho MEDARTIS IMPORTAÇÃO E EXPORTAÇÃO LTDA./SP

MembersEduardo Ferreira Simões (holder)IMPLAMED IMPLANTES ESP. COM. IMPOR. EXP. LTDA./SP

Henrique Cesar Martins (1st substitute) HMS IMPORTAÇÃO E COMÉRCIO DE PRODUTOS MÉDICOS LTDA./SP

Rogério Pinheiro Gerszt (2nd substitute) MEDICAL SUTURE COMÉRCIO LTDA./ES

EXECUTIVE AND TECHNICAL TEAM

Executive BoardBruno Boldrin Bezerra

Technical DirectorySérgio Alcântara Madeira

Administrative team

Daise de Oliveira DominguesFINANCE/ ADMINISTRATION

Flávia GuimarãesSECRETARY

Liliam Salazar MEMBERSHIP SUPPORT

Lucas MacedoGOVERNMENT RELATIONS

Tatiane Munhoz COMMUNICATION

ACCOMPLISHMENT

Brazilian Association of Importers and Distributors of Health Products - ABRAIDIWebsetorial Economical Consulting

Collaboration(in alphabetic order)

Bruno Boldrin Bezerra (ABRAIDI)Lucas Flávio de Macedo (ABRAIDI)Patrícia Véras Marrone (Websetorial)Sérgio Alcântara Madeira (ABRAIDI)Sérgio Dilamar Bitencourt da Rocha (ABRAIDI)

Graphic project: Laika DesignPrinting: Centrográfica

Summary

Letter to the Reader

13

15 Mission, Vision and Values

17 Actions and Numbers of ABRAIDI

39 The Health Products Sector

18 Numbers

42 Industry and Domestic Market Numbers

24 Main Themes and Actions - 2018

51 Foreign Trade Data on Health Products

31 Compliance

Chapter 1

Chapter 2

Associated companiesABRAIDI - 2018

114

65 The market for medical devices and their price dynamics

97 Billingretention

72 Analysis of the evolution of the prices of selected products

102 Disallowances

112 conclusions

105 Default

106Hospitaldiscount

110 Unpaidservices

111 Losses due to distortions

113 References

79 Evolution of the marketing prices of MEDICAL DEVICES in the countries analyzed

92 conclusions

Chapter 3 Chapter 4

Comparative price analysis of implantable medical devices in selected countries

63 Distortions of the health system

95


LIST OF GRAPHS

GRAPH 1: Segmentation of ABRAIDI associates by type of activity. Page 18

GRAPH 2: Distribution of ABRAIDI associates by size (annual turnover). Page 19

GRAPH 3: Distribution of ABRAIDI associates by region. Page 20

GRAPH 4: Distribution of ABRAIDI associates per federation unit. Page 21

GRAPH 5: Segmentation of ABRAIDI associates by specialty. Page 22

GRAPH 6: Monthly surgical volume in the main actuation specialties. Page 23

GRAPH 7: Status of ABRAIDI associates in relation to compliance programs. Page 37

GRAPH 8: ABRAIDI associates that have sub-dis-tributors. Page 42

GRAPH 9: Quantification of sub-distributors for companies that claimed to work with these. Page 42

GRAPH 10: Number of surgical technologists in the staff (permanent and temporary). Page 43

GRAPH 11: Sales volume of materials from ABRAIDI associates to SUS. Page 44

GRAPH 12: Top 10 main products sold by ABRAIDI associates to SUS. Page 45

GRAPH 13: Contracting of ABRAIDI associates.

Page 46

GRAPH 14: Participation of the players in the contract with ABRAIDI associates. Page 46

GRAPH 15: ABRAIDI associates selling products covered by the ICMS Agreement n. 01/1999.

Page 47

GRAPH 16: Consequences of the end of the ICMS (Goods and Services Circulation Tax) Agreement n. 01/1999 for the associates ABRAIDI. Page 48

GRAPH 17: Distribution of ABRAIDI associates ‘ in-voicing by paying source. Page 49

GRAPH 18: Distribution of revenue from ABRAIDI associates by private payer source. 0

GRAPH 19: Production of implantable medical devices, materials and support equipment in Bra-zil. Page 51

GRAPH 20: Commercial balance of implantab-le medical devices, materials and support equip-ment. Page 52

GRAPH 21: Percentage share of imports in the apparent consumption of implantable medical devices, materials and support equipment.

Page 53

GRAPH 22: Main countries of origin of implanta-ble medical devices, materials and support equip-ment imports. Page 54

GRAPH 23: Main destination countries for ex-ports of implantable medical devices, materials and support equipment. Page 58

GRAPH 24: Annual average prices for non-dru-g-eluting stents paid by health care providers or hospitals in Latin American countries, in the Uni-ted States, and in European countries, in US dollar from 2014 to 2018. Page 83

GRAPH 25: Annual average prices for drug-elu-ting stents paid by health care providers or hospitals in Latin American countries, in the United States, and in European countries in US dollar from 2014 to 2018. Page 86

GRAPH 26: Average annual prices of primary total knee replacements paid by health care pro-viders or hospitals, in Latin American countries, in the United States, and in European countries, in US dollar from 2014 to 2018. Page 91

GRAPH 27: Billing of ABRAIDI associates retained by paying source. Page 98

GRAPH 28: Average number of days until the issuance of ABRAIDI associates’ invoices for each paying source. Page 99

GRAPH 29: Average number of days between in-voice issuance and payment - ABRAIDI associates, by paying source. Page 100

GRAPH 30: Occurrence of the practice of di-sallowance by health plans or operators.

Page 103

GRAPH 31: Total volume of disallowance of ABRAIDI associates. Page 104

GRAPH 32: Occurrence of losses with default by hospitals, operators and public agencies. Page 105

GRAPH 33: Occurrence of the hospital discou-nt practice. Page 106

GRAPH 34: Occurrence of retaliation when denying the hospital discount concession. Page 107

GRAPH 35: Percentage of ABRAIDI associates who resold the customer, even after refusing to grant the discount. Page 108

GRAPH 36: Occurrence of pressure by the hos-pital for the discount, even when the billing is done for the health plan. Page 109

GRAPH 37: Occurrence of unpaid services pro-vided by associates ABRAIDI. Page 110

GRAPH 38: Additional costs to the distributor’s operation due to distortions in the health pro-ducts sector. Page 111


FIGURE 1: Meeting with Anvisa’s (National He-alth Surveillance Agency) Director of Health Mo-nitoring and Control at the time, Dr. William Dib and the Ports, Airports and Borders Management. Page 24

FIGURE 2: RMeeting with the directors of ANS (National Supplementary Health Agency) Rodri-go Rodrigues Aguiar and Simone Sanches Freire, in which data and information on the problem of billing retention were presented.Page 25

FIGURE 3: Meeting with TCU’s (Federal Court of Accounts) Secretary of External Health Control, Marcelo Chaves, to discuss the distortions in the health area, including billing retention. Page 26

FIGURE 4: Meeting with CGU’s (Transparency Mi-nistry) Secretary of Transparency and Prevention of Corruption, Claudia Taya and the general coor-dinator of Audit of the Health Area of the CGU, Ale-xandre Gomide Lemos. Page 26

FIGURE 5: Meeting with the Executive Secretary of the Civil House at the time, Daniel Sigelmann, in November 2018 - Brasília/Federal District.

Page 27

FIGURE 6: President of ABRAIDI, Sérgio Rocha, at the Compliance Healthcare Forum. Page 31

FIGURE 7: Entities from Argentina, Brazil, Chile, Colombia, the United States and Mexico participa-ting in the meeting in Philadelphia. Page 32

FIGURE 8: President of ABRAIDI, Sérgio Rocha, participates in Compliance Across Americas. Page 33

FIGURE 9: Executive Director, Bruno Boldrin Be-zerra, represented ABRAIDI at the event. Page 33

FIGURE 10: Opening of the 1st Workshop Com-pliance for Distributors. Page 35

FIGURE 11: Closing lecture of the workshop by the Prosecutor Deltan Dallagnol, member of the Car Wash Task Force. Page 35

FIGURE 12: Representation of the Structure-Con-duct-Performance Paradigm. 6

FIGURE 13: Macroeconomic health data in Brazil - 2018. Page 68

FIGURE 14: Average time between invoice issuan-ce and receipt of ABRAIDI Associates. Page 101

LIST OF FIGURES

TABLE 1: Main countries of origin of imports of implantable medical devices, by product - 2018. Page 56

TABLE 2: Main destination countries for exports of implantable medical devices, by product - 2018. Page 61

TABLE 3: Twenty major medical devices purcha-sed by SUS in 2018 in total purchase amounts. Page 73

TABLE 4: Twenty major medical devices purcha-sed by the Private System in 2012 in total purchase amounts. Page 74

TABLE 5: Annual average prices for non-drug--eluting stents paid by health care providers or hospitals in Latin American countries, the United States, and European countries, in US dollar, from 2014 to 2018. Page 82

TABLE 6: Annual average prices for stents with drugs paid by health care providers or hospitals, in Latin American countries, in the United States and in European countries, in US dollar, from 2014 to 2018. Page 85

TABLE 7: Average annual prices of primary total knee replacements paid by health care providers or hospitals, in Latin American countries, in the Uni-ted States, and in European countries, in US dollar, from 2014 to 2018. Page 89

LIST OF TABLES

12 THE CYCLE OF THE SUPPLY OF HEALTH PRODUCTS IN BRAZIL

In 2018, ABRAIDI has dedicated itself to de-monstrate to society, the health sector and gover-nment agencies the importance and details of the operation of import and distribution activities for health products throughout the country. We did this in the first edition of the publication The cy-cle of supply of health products in Brazil, bringing numbers and unpublished data about the sector, extracted from a wide research with ABRAIDI as-sociates.

Rather than presenting this information as a contribution to the health debate, we sought to show the difficulties faced by an industry that is now widely dispersed throughout the country and is vital for the health care of millions of Bra-zilians and is in crisis, accompanying much of the whole chain.

In this second edition, we seek to publish up-dated numbers on the health products supply sector in Brazil and establish comparisons with previous results, to measure market trends that can guide not only the companies themselves in their businesses, but also help in definition of public policies that seek the sustainability of all health players.

In addition to stating that persistent and structural problems of the health system persist and, in some cases, increased in size and volume, ABRAIDI shows unprecedented data on a compa-

Letter to the Reader

rative price of medical devices in various countries around the world, a question that has always been raised in public debates, but with little con-crete data.

Although we understand a sample of two pro-ducts widely used in the Brazilian public and pri-vate systems, international price data show that our market, contrary to what many people say, is not outside the world curve when compared to developed countries, and even to countries at the same stage of development in Brazil.

Again, ABRAIDI’s proposal to present these data is to provoke reflection and offer content for the debate. After all, the sustainability of the Brazi-lian health sector is vital for millions of people and it will only happen, based on structural changes that must be made by all.

Sérgio Dilamar B. da RochaChairman of the Board of Directors


MISSiOnVISiOn

VALuESEnsure that associate companies are known to be at the forefront of health solutions.

To be the representative association of distributors and importersof products for health, based on ethics and transparency, promoting actions that make our associates references in the market for health.

Of good citizenship, which include:> Ethics> Social Responsibility > Systems and quality management> Continuous focus on the fragile being - the patient

Mission

Vision

Values

1Actions and Numbers of ABRAIDI

1. ACTIONS AND NUMBERS OF ABRAIDI19THE CYCLE OF THE SUPPLY OF HEALTH PRODUCTS IN BRAZIL18

NUMBERS

294ASSOCIATES1

more than

13 THOUSAND R$ 4,8 BILION3

DIRECT JOBS2 REVENUE IN 2018

ACTIONS AND NUMBERS OF ABRAIDI

Source: ABRAIDI

DISTRIBUTORONLY 138 - 47%

IMPORTER AND DISTRIBUTOR 129 - 44%

IMPORTERONLY 10 - 3%

DISTRIBUTOR AND MANUFACTURER 3 - 0.5%

IMPORTER AND MANUFACTURER 2 - 0.5%

IMPORTER, DISTRIBUTOR AND

MANUFACTURER12 - 5%

1February/2019 2Estimate based on research with associated companies (sample = 116).

3Estimate based on research with associated companies (sample = 116).

Segmentation of ABRAIDIassociates by type of activity.In % and number of associates – February / 2019

GRAPH 01

19Great II %

7Great I %

13Micro %

20Small %

41Medium %

Distribution of ABRAIDI associates by size(annual turnover).In % of associates – February, 2019

Source: ABRAIDI

ABRAIDI Size Classification (in annual turnover):

Micro: until R$2 billion;Small: more than R$2 billion;Medium: more than R$6 billion;Great II: more than R$20 billion;Great I: more than R$50 billion.

GRAPH 02


Distribution of ABRAIDI associates by region.In % of associates – February, 2019

Source: ABRAIDI

15

83

14

Northeast

Midwest

North

South

60Southeast %

%

%

%

%

GRAPH 03

SÃO PAULO 118 - 40%

33 - 11%RIO DE JANEIRO

MINAS GERAIS 15 - 5%DISTRITO FEDERAL 13 - 4.5%ESPÍRITO

SANTO 12 - 4%

PERNAMBUCO 12 - 4%

BAHIA 9 - 3%

CEARÁ 8 - 3%

PARÁ 5 - 2%

SANTA CATARINA

GOIÁS

MATO GROSSODO SUL 4 - 1%

4 - 1%

4 - 1%

RIO GRANDE DO NORTE

ACRE 1 - 0.5%

1 - 0.5%

MATO GROSSO 4 - 1%

AMAZONAS 3 - 1%

3 - 1%

3 - 1%

MARANHÃO

PARAÍBA

ALAGOAS 2 - 1%

2 - 1%

2 - 1%

SERGIPE

PIAUÍ

19 - 6.5%PARANÁ

RIO GRANDE DO SUL 17 - 6%

Source: ABRAIDI

Distribution of ABRAIDIassociates per federation unit.In % and absolute number of associates - February, 2019

GRAPH 04

1. ACTIONS AND NUMBERS OF ABRAIDI 1. ACTIONS AND NUMBERS OF ABRAIDI22 23THE CYCLE OF THE SUPPLY OF HEALTH PRODUCTS IN BRAZILTHE CYCLE OF THE SUPPLY OF HEALTH PRODUCTS IN BRAZIL

1 It is common for importers and distributors to work in various specializations at the same time.

2 Cardiovascular surgery comprises cardiology, vascular surgery and interventional cardiology.

3 Orthopedics also includes spine.

4 Special materials: any materials or devices for individual use that aid in diagnostic or therapeutic procedures and that do not meet the specifications of orthoses or prostheses, implantable or not,

and may or not undergo reprocessing, according to rules determined by Anvisa.

CARDIOVASCULARSURGERY 2 67%

63%ORTHOPEDICS3

GENERALSURGERY 21%

UROLOGY 15%

CONSUMPTION 12 %PLASTIC

SURGERY 9%

MAXILLOFACIAL 9%

NEPHROLOGY 5%

DENTISTRY 5 %

OPHTHALMOLOGY 4%

RADIOLOGY 4%

18%OTHERS

53%NEUROSURGERY

SPECIALMATERIALS4 24%

Source: ABRAIDI

Segmentation of ABRAIDIassociates by specialty.1

In % of associates – February, 2019

GRAPH 05

1It is common for importers and distributors to work in various specializations at the same time.

2Calculated based on sample from ABRAIDI Associate Research.

3Orthopedics also includes spine.

4Cardiovascular surgery comprises cardiology, vascular surgery and interventional cardiology.

5Special materials: any materials or devices for individual use that aid in diagnostic or therapeutic procedures and that do not meet the specifications of orthoses or prostheses, implantable or not, and may or not undergo reprocessing, according to

rules determined by ANVISA (MINISTRY OF HEALTH, loc cit.)

Source: Research Associates ABRAIDI; Websetorial.

Monthly surgical volumein the main actuation specialties.1

In number of surgeries and total % - 2018

40000

45000

30000

20000

10000

35000

5000

25000

0

15000

OR

TH

OPE

DIC

S A

ND

SPI

NE

3

4037456%

CA

RD

IOVA

SCU

LAR

SU

RG

ERY

4

1382519%

NEU

RO

SUR

GER

Y

705310%

CO

NSU

MPT

ION

36005%

GEN

ERA

LSU

RG

ERY

35905%

SPEC

IAL

MAT

ERIA

LS 5

16282%

OT

HER

S

19143%

The monthly surgical volume in orthopedics is much higher than the others, representing more than half (56%) of the monthly surgeries counted.

Altogether, it is estimated that more than 863 thousand surgeries at-tended by ABRAIDI associates per year in the main areas of expertise.

TOTAL: 71.985 SURGERIES/MONTH2

GRAPH 06


adoption of electronic forms;centralization of the analysis of petitions in

“virtual posts”, divided by type of product, with de-dicated servers;

simplification and de-bureaucracy of import rules and procedures – Anvisa’s Resolution n. 208/2018;

disclosure of information regarding the num-ber of pending review cases and deadlines on An-visa’s website;

consolidation of the risk management proce-dure in import processes – Anvisa’s Resolution n. 228/2018;

implementation of the load parameterization mechanism, similar to what is done by the Inter-nal Revenue Service.

While the overall picture has improved, ABRAI-DI constantly monitors the situation with its im-porting partners and maintains an open channel of dialogue with the Agency to report problems. Therefore, it is still necessary for Anvisa to invest in Information Technology (IT) to modernize the sys-tems that currently perform all these operations, giving greater agility to processes and avoiding “blackouts”, which harm not only health products companies, but also those of other important sec-tors, such as the pharmaceutical sector.

Given the significant volume of imports of he-alth products that Brazil undertakes every year, the decentralization of the liberation process, budge-tary problems and human resources - many Anvisa servants in the PAB areas retired and the vacancies were not the average duration of health releases, which reached 50 working days in 2016, is now an average of 3-5 working days working days, thanks to a series of changes proposed by ABRAIDI and the other entities in the sector, adopted by Anvisa.

Main changes in the sanitary release process of imported products for health:

ABRAIDI, together with other entities in the sector, worked with Anvisa to pro-pose measures and find solutions that would reduce the average sanitary rele-ase period of imported products for health.

PORTS, AIRPORTSAND BORDERS (PAB)

*

MAIN THEMES AND ACTIONS - 2018

Figure 1. Meeting with Anvisa’s (National Health Surveillance Agency) Director of Health Monitoring and Control at the time, Dr. William Dib and the General Ports, Airports and Borders Management.

The practice totaled R$ 539.6 million in 2017, with an average of 64 days for invoice issuance and another 106 days for the actual payment of surgeries already performed and previously au-thorized.

Based on this survey, ABRAIDI held dozens of meetings with government authorities to present and discuss the problem, with a view to finding ways and presenting contributions to eliminate this distortion that today negatively impacts the entire health system and, above all, patients/con-sumers who pay the bill.

The practice totaled R$539.6 million in 2017.

In 2018, ABRAIDI launched the first edition of this publication The cycle of su-pplying health products in Brazil, which unmistakably presented a survey of the estimated total amount of resources of ABRAIDI associates that were pen-ding billing.

*

BILLINGRETENTION

Figure 2. Meeting with the directors of ANS (National Supplementary Health Agency) Rodrigo Rodrigues Aguiar and Simone Sanches Freire, in which data and information on the problem of retention of billing were presented.


In 2019, in addition to updating the research with associates to measure the size of the amou-nt of resources related to withholding, ABRAIDI filed a formal complaint about the practice with the competent governmental bodies, collecting provisions and exposing the main problems that retention of invoicing causes to patients and su-ppliers of health products. *

ABRAIDI submitteda formal complaint about the practice to the relevant government agencies.

Figure 4. Meeting with CGU’s (Transparency Ministry) Secretary of Transparency and Prevention of Corruption, Claudia Taya and the general coordinator of Audit of the Health Area of the CGU, Alexandre Gomide Lemos.

Figure 3. Meeting with TCU’s (Federal Court of Accounts) Secretary of External Health Con-trol, Marcelo Chaves, to discuss the distortions in the health area, including billing retention.

Only in taxes collected by suppliers, the impact could reach R$30 million, if the same import vo-lumes were maintained.

ABRAIDI, upon becoming aware of the me-asure, immediately began a collaborative work with the Ministry of Health and interlocution with the other organs of the Federal Government involved in the decision, with the objective of bringing data and information about the market for health products, in order to demonstrate the negative impacts that such an action brought to the whole system.

In addition to the products for fractures, NCMs of femoral and non-femoral joint prostheses, as well as catheters, probes and cannulas were also

In July 2018, the Executive Management Committee (Gecex) of the Federal Go-vernment’s Foreign Trade Chamber (Camex), during the process of revision of the List of Exceptions of the Mercosur Common External Tariff (Letec), remo-ved the classified health products in NCM 9021.10.20 (articles and appliances for fractures) of the List of Exceptions, which resulted in an increase in the Im-port Tax (II) rate of these products from 4% to 14%.

under review. If these products had their Import Tax rates increased, the impact on the system would be at least R$160 million.

After ABRAIDI demonstrated these negative effects for the entire system, Camex decided, in November 2018, to keep these products on the List of Exceptions with reduced II aliquots. In addition, ABRAIDI continues to work with the Fe-deral Government for the reinstatement of arti-cles and appliances for fractures in the Exceptions List, as well as other product categories such as scalpels and anesthesia devices and equipment, with the objective of reducing aliquots, avoiding the costs throughout the health system and allowing better population access to these tech-nologies.*

MAINTENANCE OFIMPORT TAX RATES FORHEALTH PRODUCTS

Figure 5. Meeting with the Executive Secretary of the Civil House at the time, Daniel Sigelmann, in November 2018 - Brasília/Federal District.


Since 2007, ABRAIDI has been supporting associates in contacts with Anvi-sa to meet requirements for non-sterile implantable medical device records, more specifically plaques and screws required for orthopedic surgeries, in the face of non-conformities created with the publication of Anvisa’s Resolution n. 156/2006.

There have been numerous meetings and requests for changes in the framework of these specific medical devices in this Anvisa’s Resolu-tion, which currently prohibits reprocessing and marketing.

Efforts were redoubled from February 2018 to propose changes by removing non-sterile sin-gle use implants from the same sanitary rule as permanent single use implants. The regulatory order is incompatible with the current reality of the health system: distributors, hospitals, medi-cal teams. We emphasize that there is no proven evidence of injury to patients due to this practice, corroborated by the Brazilian Society of Orthope-dics and Traumatology (SBOT), our partner in the claims, together with Abimo, Abimed and CBDL.

After a series of meetings with the associates, with the abovementioned entities and with An-visa itself, we presented in August 2018 a Resolu-tion proposal that advocates a specific treatment for these medical devices, as in other regulatory exception situations, such as reprocessing in the area of cardiac surgery (the recent Anvisa’s Re-solution No. 256/2018) and reprocessing of dialy-zers. Although the solutions presented by ABRAI-DI could be considered imperfect, in the face of the regulatory impasse throughout the national territory, it would be important for the agency

to lead a working group involving the various stakeholders, both in the regulated sector and in the regulatory sector.

ABRAIDI understands that there are contro-versial issues such as traceability, the opening of packaging to assemble the cartons, the question of control and billing of the items consumed, as well as the issue of the supply of sterile products, plates and screws, in packages units. However, there are issues without controversy, such as the unequivocal responsibility of cleaning instru-mental assemblies and processing:

Efforts were redoubled in February 2018 to propose changes.

REPROCESSINGOF TRAUMA PRODUCTS

Manufacturer’s responsibility: the manufacturer develops and produces these non-sterile medical devices, and specifies in the instructions for use the conditions of pre-processing and sterilization by the hospital prior to surgery in patients;

Supplier’s responsibility: to receive and deliver the material received from the manufacturer under the conditions specified in the records, observing good distribution and storage practices;

Responsibility of the manufacturer/supplier and the hospital: the orthopedic instrumented set should be provided revised and cleaned and then processed by the health service, as indicated by the manufacturer, prior to operative procedures, in accordance with world-renowned rules to en-sure sterilization and safety for use in patients;

Hospital responsibility: Like any surgical instru-ment box, orthopedic instruments should be cleaned, cleaned and decontaminated, processed according to world-recognized rules, after surgery, to ensure the safety of users and people in the hospital environment, preventing the spread of hospital infection. There is no doubt that it is the hospital that holds the sanitary authorization, the technology, the facilities, the equipment, the con-sumables and the disinfectants, the specialized professionals and the human resources dedicated to these tasks;

Supplier responsibility: collect clean and deconta-minated assemblies, check, replace components for process restart.

The adoption of other procedures, already validated, by the industry is perfectly possible, for example the systematic adoption of medical de-vices of trauma in sterile presentation and indivi-dual packaging, if Anvisa so decides and regulates, including impact analysis. Another interesting point to note is that in many hospitals abroad, the instruments are owned by hospitals and dozens of consigned medical device boxes are stored in controlled environments in the health services.

The industry is, as always, willing to imple-ment new processes, in order to follow global trends through the adoption of technologies that benefit all, but with a special focus on patients, in order to participate in the expansion of access with quality and safety needed.

ABRAIDIPROPOSALS

1

2

3

4

5

Regulate the provision of non-ste-rile, single-use medical devices in instrumented boxes for the prepa-ration and processing of implants for surgery and subsequent processing of unused medical devices.

Regulate the logistical and commer-cial process of consignment, espe-cially contracting, from the point of view of best practices.

*


Through meetings with the Directorate of Te-chnical Division of the DSV, of the Department of Transportation of the Municipality of São Paulo, and also with the Working Group for studies and sharing of experiences for the management of the exceptionalities of the “Traffic Restriction Pro-gram of Motor Vehicles in the Municipality of São Paulo” (“Rodízio Municipal”) - created by Order DSV.GAB n. 44, dated April 20, 2018, ABRAIDI was able to successfully detail and include as neces-sary the exemption of vehicles transporting health products, as a matter of urgency or emergency.

Based on the study carried out by the Working Group of the Department of Opera-tion of the Road System (DSV), the mayor of São Paulo issued Decree no. 58,584, dated Decem-ber 20, 2018, revising the old regulation of the

Since 2017, attending to an associates’ demand, ABRAIDI has been working to include the vehicles responsible for transportation of health products in the city of São Paulo in the exemption of the Municipal Carrier Rotation, instituted by Municipal Law n. 12,490, of October 3, 1997 - Program for the Restriction of Traffic in Motor Vehicles in the Municipality of São Paulo - Rodízio Municipal Vehicular.

Municipal Rotation and, after that, the DSV pu-blished Order SMT.DSV.GAB n. 09, dated January 30, 2019, establishing the criteria for requesting the exemption, stating that a pre-registration system will be implanted in a gradual way to identify exempted vehicles.

The registration system is not yet available and is in the process of developing a system and legislation to comply with Law n. 16.813/2018, which establishes the register. ABRAIDI will ac-company this phase of implementation, and will later communicate with details to the associates the procedures for carrying out the registration directly in the system or by ABRAIDI itself. With the registration, the vehicles will receive an automatic identification of “exempted vehi-cles”, that treats the Municipal Law n. 16,813, da-ted February 1, 2018.*

EXEMPTION FROM CARRIAGE FOR VEHICLES OF COMPANIES TRANSPORTING HEALTH PRODUCTS IN THE CITY OF SÃO PAULO

In 2018, ABRAIDI continued the expansion of activities related to ethics and compliance issues for its associates, achieving significant advances. In addition to the holding and participation of a series of events on the subject, ABRAIDI launched the Compliance in Action program, with the ob-jective of disseminating knowledge and assisting in the qualification and qualification of associates for the implementation of integrity and risk mi-tigation programs.

The event, held in April 2018, was jointly or-ganized by ABRAIDI, ABIIS, Abimed and CBDL and discussed the strengthening of the ethical business environment in Brazil. Five panels discussed the ma-turity of compliance in the country, the challenges still faced by the medical device sector, both in the public and private sectors, compensation in the he-althcare chain and how ethics can bring solutions.

The participation of the president of ABRAIDI, Sérgio Rocha, who mediated the panel with the theme “How the remuneration in the health chain and how ethics can interfere in the relations?”, in-serting controversial issues in the discussion, such as the requirement of non- agreed upon by hos-pitals as a condition of sale and what has been the role of the authorities to curb these practices.

COMPLIANCE

COMPLIANCE HEALTHCARE FORUM

In 2018, ABRAIDI continued the expansion of activities related to ethics and compliance issues for its associates.

*

Figure 6. President of ABRAIDI, Sérgio Rocha, at the Compliance Healthcare Forum.


In 2018, the Inter-American Coalition of Ethi-cs in the Medical Devices sector held its third and fourth meetings. The first occurred in April, in São Paulo, and counted with notable participation of the Brazilian entities of the sector. At the meeting, the actions to be developed by the entities during the year and the schedule of expected results were agreed.

The second meeting of the year took place in September in Philadelphia, USA, during the Me-dTech Conference, where ABRAIDI and the other participating entities were able to present the pro-gress of the compliance initiatives with associates and the action plan for 2019.

MEETINGS OF THE INTER-AMERICAN ETHICS COALITION

ABRAIDI Executive Director Bruno Bezerra presented the main achievements of ABRAIDI, hi-ghlighting the work of the Ethics and Processing Commission, the creation of the Compliance in Action Program and its initial results. Only in the first two editions of Module 1 (basic compliance course) were 87 participants from 64 associated companies from 13 different states.

ABRAIDI is one of the founders of the Inter-American Ethics Coalition.

*

Figure 7. Entities from Argentina, Brazil, Chile, Colombia, the United States and Mexico participatingin the meeting in Philadelphia.

Also in April, the president of ABRAIDI, Sérgio Rocha, par-ticipated in the panel “Compliance in the area of health” at the Compliance Across Americas event in São Paulo. During the discussion, ABRAIDI’s actions regarding compliance, in-cluding capacity building initiatives, were presented. In ad-dition to ABRAIDI, the panel was the president of the Health Ethics Institute, Gláucio Libório; the compliance director of the Albert Einstein Hospital, Viviane Miranda, and complian-ce lawyer Giovanni Saavedra.

Compliance Across Americas

In May, ABRAIDI participated in the Global Medtech Compliance Conference in France, an event promoted by AdvaMed and MedTech Europe. ABRAIDI Executive Director Bruno Boldrin was one of the panelists on the distributor compliance panel.

In his speech, he detailed the reality of distributors in Brazil, who face serious distortions, such as billing retention and hospital discount, citing unpublished data from the first edition of the publication The cycle of supply of health pro-ducts in Brazil. In addition, Bruno Boldrin highlighted the wide range of services provided by the Brazilian distributor that are not remunerated by hospitals or healthcare provi-ders, the amount of responsibilities that distributors accu-mulate, compared to similar companies in other countries, and also stressed the importance of manufacturers approa-ch and act as partners for their distributors.

Global Medtech Compliance Conference

*

Figure 8. President of ABRAIDI, Sérgio Rocha, participates in Compliance Across Americas.

Figure 9. Executive Director, Bruno Boldrin Bezerra, represented ABRAIDI at the event.

*


ABRAIDI, maintaining its leadership role in he-alth compliance and with the objective of collabo-rating and assisting its associates in the adoption of integrity programs and systems, has launched in partnership with the School of Corporate Ethi-cs, Business and Innovation (Eseni) and with the support of the Ethical Health Institute, the “Com-pliance in Action” Program, which has four modu-les in the areas of awareness, education, technical support, monitoring and compliance certification.

The program is permanent and consists of 4 independent modules, in which the company chooses the module of which it wishes to parti-cipate, according to its stage of development in compliance.

ABRAIDI COMPLIANCEIN ACTION PROGRAM

4 modules:

> Basic courseon compliance> Compliance officer training> Technical support> Certification.

*

I WORKSHOP COMPLIANCE FOR DISTRIBUTORS

On November 8, ABRAIDI, in partnership with AdvaMed, held the 1st Workshop Compliance for Distributors, promoting interaction among parti-cipants with case studies, training in various topics related to compliance. The event was attended by 150 executives from manufacturing companies, importers and distributors of health products and had the registrations sold out.

At the end of the workshop, participants at-tended the lecture “Ethics and the Fight against Corruption”, given by the Prosecutor, Deltan Dallagnol, who is in Operation Car Wash.

Workshop fruit of the partnership between ABRAIDI and AdvaMed was attended by 150 industry participants, importers and distributors.

Figure 10. Opening of the 1st Workshop Compliance for Distributors.

*

Figure 11. Closing lecture of the workshop by the Prosecutor Deltan Dallagnol, member of the Car Wash Task Force.


ActionsDeveloped

In 2018, the percentage of ABRAIDI associates surveyed who had some compliance action reached 90.7%, compared to 72% in 2017, with 25.9% of the companies already having the compliance program fully implemented.

25 courses, events and lectures on compliance carried out between 2013 and 2018

More than 600 participants

200 associates companies participated

14%

9.3%

26%

13%

46%

51.8%

14%

25.9%

DO NOT HAVE HAVE A CODE OF CONDUCT AND ARE DEVELOPING COMPLIANCE PROGRAM

HAVE ONLY A CODE OF CONDUCT

HAVE A FULLY IMPLEMENTED COMPLIANCE PROGRAM

Status of ABRAIDI associatesin relation to compliance programs.In % of associates – 2018

Source: ABRAIDI based on sampling research, with associated companies.

20172018

GRAPH 07

2The Health Products Sector

2. THE HEALTH PRODUCTS SECTOR41THE CYCLE OF THE SUPPLY OF HEALTH PRODUCTS IN BRAZIL40

Among the segments that make up the index, the area of orthoses, prostheses and special mate-rials (medical devices), specifically, showed growth of 5.4%. In the labor market, the sector registered a 4.6% increase in the number of employees, re-aching 139 thousand workers, considering the industry and the wholesale and retail trade of he-alth products.

In relation to international trade, the medi-cal devices segment registered a 9.7% increase in imports in 2018 compared to 2017, while exports registered a decline of 8.1%. If we consider all the segments – medical devices materials and equi-pment, and in vitro diagnostic reagents, imports increased 21.8% and exports registered a decrease of 7.3% when compared to 2017.

In the regulatory field, 2018 was filled with change. At the beginning of the year, the validity of the registration of health products was increased from 5 to 10 years. In addition, the electronic pe-tition system for health products was implemen-

1 ABIIS – Boletim Econômico nº 25 – jan.-dez./2018.

ted. The measure made it possible for companies to electronically send the necessary documents to comply with the notifications of requirements received as a result of the analysis of the petitions. It is important to mention Anvisa’s Resolution n. 232/2018, which provides for the inclusion of linear or two-dimensional bar codes on stent traceabili-ty labels for coronary arteries, coronary stents for coronary arteries, and implants for hip and knee arthroplasty.

On the import side, after intense discussions with the industry, including the active participa-tion of ABRAIDI, Anvisa took an important step in modernizing processes by editing Anvisa’s Resolu-tion n. 208/2018, which simplified the procedures

According to bulletin1 of the Brazilian Innovattive Healthcare Industry Alliance (ABIIS), the apparent consumption of health products in Brazil grew 13.5% in 2018 compared to 2017.

THE HEALTH PRODUCTS SECTOR

for importation of products subject to sanitary surveillance, hitherto governed by Anvisa’s Reso-lution n. 81/2008, accepting part of the proposals presented by ABRAIDI. During the year, procedu-res were also adopted for risk management and parameterization of cargoes, which streamlined the processes of analysis and release of imported goods, reducing their deadlines.

It is also worth mentioning the change in the rules for renewal of the Good Manufacturing Practices Certificate (CBPF) for Health, Cosmetic or Sanitary Products or the Certificate of Good Prac-tices of Distribution and Storage (CBPDA) of Health Products. The creation of subject codes is inten-ded to provide greater agility in the distribution and analysis of renewal petitions and to harmo-nize the flow of processes with other flows within the Agency.

In 2018, the segment of medical devices posted growth of 5.4% in the apparent consumption index.

For imported products, the main change in 2018 was the withdrawal, by the Foreign Trade Chamber of Internal Revenue (Camex), of NCM 9021.10.20 (articles and appliances for fractures) of the Mercosur Common External Tariff Exemption List, the which raised the Import Tax rate from 4% to 14%. In addition, aliquots were maintained for 3 other classifications (femoral joint prostheses, non-femoral joint pros-theses, cannulas, catheters and probes). In 2019, ABRAIDI sent information to the Ministry of Health to support the technical analysis of the Working Group, which will analyze NCM’s request for reinstatement of articles and devices for fractures, in addition to any reduction.*

NUMBERS OF THE SECTOR AND INTERNAL MARKET


77,6

69

11

84

8

ABRAIDI associates thathave sub-distributors.In % - 2018

Yes

Until 5

More than 20

From 11 to 15

From 16 to 20

From 6 to 10

No 22,4%

%

%

%

%

%

%

Source: ABRAIDI Research – Websetorial

Quantification of sub-distributors forcompanies that claimed to work with these.In number of sub distributors – 2018


GRAPH 08

GRAPH 09


Number of surgical technologistsin the staff (permanent and temporary).In number of surgical technologists – 2018

50

3532

2522

50

60

40

30

20

10

0

60 10020 40 80

According to the research, the average number of surgical technologists contracted per company is 7 professionals.

The surgical technologists as well as the perfusionist, is an indispensable element for performing a surgical procedure. For some years now, in many ca-ses, this professional is hired and paid by the supplier of the product for health, but the latter, in most cases, cannot charge for this service, under penalty of retaliation from the hospitals or the operators that buy the products.

ABRAIDI defends the regulation of the profession of surgical technologists, under discussion in the National Congress, and believes that the responsibility or obligation of hiring these professionals must be of the service providers, aiming to avoid legal uncertainty for professionals, providers and suppliers, be-sides risks related to compliance.

NUMBER OF RESPONDENTS TO QUESTION

QU

AN

TIT

Y O

F SU

RG

ICA

L T

ECH

NO

LOG

IST

S

*

GRAPH 10

2. THE HEALTH PRODUCTS SECTOR 2. THE HEALTH PRODUCTS SECTOR44 45THE CYCLE OF THE SUPPLY OF HEALTH PRODUCTS IN BRAZILTHE CYCLE OF THE SUPPLY OF HEALTH PRODUCTS IN BRAZIL

1,400

1,340

1,380

1,360

1,320

1,300

1,280

1,260

Sales volume of materials fromABRAIDI associates to SUS.In R$ millions

Source: Datasus/InfoABRAIDI.

The volume of sales (in R$) to SUS, by ABRAIDI members, has grown for 4 consecutive years. From 2015 to 2018, sales increased 5.94%.

The ABRAIDI members were responsible for the sale of R$ 1.39 billion in health products to SUS in 2018, an increase of R$ 44 million over 2017.

2015

1,313

2016

1,316

2018

1,391

2017

1,347

GRAPH 11

Source: Source: DATASUS/InfoABRAIDI.

The most sold product by ABRAIDI associates to the SUS in 2018 was the co-ronary artery stent, which represented 11.6% (R$ 160 million) of sales, down 1.2% over the values of 2017.

The 10 main products sold by ABRAIDI associates to the SUS represent 45% (R$ 620 million) of total sales to SUS, 1% more than in 2017.

Top 10 main products sold byABRAIDI associates to SUS.In % of total value sold – 2018

CORONARYARTERY STENT 11.6%

MULTIPROGRAMMABLECARDIOVASCULAR PACEMAKER 6.8%

EXTRACORPOREAL CIRCULATION SET 4.1%

CATHETER BALLOON FOR ANGIOPLASTY 3.3%

IMPLANTABLECARDIOVERTER DEFIBRILLATOR 3.2%

SHORT LINEAR STAPLER 3.1%

CARDIOVERTERDEFIBRILLATOR WITH

MULTI-SITE PACEMAKER 2.5%

PECULIAR DEVICE FOR STEM FASTENING 2.5%

DEFINITIVEENDOCARDIAL

ELECTRODE 2.2%

PHARMACOLOGICAL STENT FOR CORONARY ARTERY 5.3%

1Total value encompasses all materials other than the top 10

TOTAL R$ 1.39 BILLION1

GRAPH 12


Contracting of ABRAIDI associates.In % - 2018

Player participation in the contractwith ABRAIDI associates. In % - 2018

Work basedon contracts

Does not workbased on contracts 10%

%90



%89.3

SUPP

LIER

S H

OSP

ITA

LS

%54.4

HO

SPIT

ALS

%36.9

HEA

LTH

INSU

RA

NC

E

%19.4

SUB

DIS

TR

IBU

TO

RS

GRAPH 13

GRAPH 14

ABRAIDI associates selling productscovered by the ICMS Agreement n. 01/1999In % – 2018

YES

NO 20%

%80


Today, an extremely relevant series of products vital to saving millions of lives is included in the ICMS (Goods and Services Circulation Tax) Agree-ment n. 01/1999, signed on March 2, 1999, in Fortaleza, Ceará, Brazil, and has been extended since then, exempting these products from the col-lection of ICMS by the States. The last renewal of the ICMS Agreement no. 01/1999 occurred on April 25, 2017, through the ICMS Agreement n. 49/2017 and is effective until September 30, 2019. To demonstrate the importance of the ICMS Agreement n. 01/1999, ABRAIDI carried out rese-arch with its associates.

Since the exemption was established, the population is directly be-nefited, since the health products contemplated by the ICMS Agreement n. 01/1999 had their prices reduced and this exemption allowed access to increasingly sophisticated technologies and products in both public and private health.

*

*

GRAPH 15

492. THE HEALTH PRODUCTS SECTOR


Consequences of the end of the ICMS Agreement n. 01/1999 for the associates ABRAIDI.In % – 2018


GRAPH 16

Looking at the graphs results, it is noticed that the ICMS exemption provided by the ICMS Agreement n. 01/1999 is vital for the continuity and maintenance of the current levels of supply of health products in the public and private networks of hospitals and emergency care units in Brazil, as well as the maintenance of businesses, jobs and taxes. Only among ABRAIDI associates, the number of com-panies that said they can terminate their activities if the agreement is not renewed reaches 43%.

%43.5

THECOMPANY COULD END

WOULD STOP ATTENDING SUS

%38.7%45.2

WOULD STOP SELLING SOME PRODUCTS OR CHANGESPECIALTY

%46.8

WOULD MAKELAYOFFS

%6.5

WOULD NOT SUFFER IMPACTS

*

Distribution of ABRAIDI associates invoicing by paying source.In % of revenues - 2018


GRAPH 17

PRIVATE

SUS 27 %

%73



According to the survey, 60.3% of the associates reported that the company’s largest client is a health care provider, while 31.5% said it was a private hospital and 8.2%, a public hospital.

In relation to the company’s revenues, the largest customers represent:

For 4.4% of companies, the largest customer accounts for up to 20% of revenue;

For 27.9%, the largest customer represents between 21% and 40% of sales;



For 8.8%, the largest customer accounts for more than 81% of revenue.

Of the sample of respondents surveyed, 76.1% stated that their largest client is a market leader in the region.

The results above illustrate the market dominance that some hospitals and he-alth care providers have in many regions of the country. 76.1% stated that

their largest customer is a market leader in the region.

*

Distribution of revenue from ABRAIDIassociates by private payer source.In % of revenues - 2018


GRAPH 18

HOSPITALS

PRIVATE/OTHERS

HEALTHINSURANCES

15

51%

%

%34

FOREIGN TRADE DATA ONHEALTH PRODUCTS

Production of implantable medical devices, materials and support equipment in Brazil5

In R$ million and US$ million

GRAPH 19

The production of medical devices, materials and support equipment in Brazil grew 5% in 2018 compa-red to 2017, reaching the value of R$ 4.8 billion.

5 In 2018, due of the classification changes, the medical device NCMs that make up the chart have been revised.

Source: IBGE/PIA PRODUTO 2016(P): projected - IBGE updates occur every 2 years

1,731

2,966

3,448

3,9814,226

4,543 4,5894,832

1,9202,124 2,065 2,056 2,057 2,160

2012 2013 2014 2015 2016 2017(P) 2018(P)

In US$ millionIn R$ million5.000

4.000

3.000

2.000

1.000

0


6In 2018, due to classification changes, the medical device NCMs that make up the chart have been revised.

7In 2018, the Ministry of Industry, Foreign Trade and Services changed AliceWeb’s foreign trade data tracking system to Comex Stat. So there may be some divergences of values between the bases.

1,400

1,200

1,000

600

800

200

400

0

1,107

1,202

1,199

1,021945 936

1,027

284 272284 267 223 258 237

2012 2013 2014 2015 2016 2017 2018

Commercial balance of implantable medical devices, materials and support equipment6 In US$ millions

Source: COMEX Stat 7

Imports +10%Exports -8%

The volume of imports of medical devices, materials and support equipment in Brazil has been much higher than that of exports in all ye-ars since 2012. In 2018, import volume (US$1.027 billion) was equivalent to almost 5 times the vo-lume of exports (US$237 million).

GRAPH 20

3,100

3,000

2,900

2,800

2,700

2,500

2,600

2,300

2,400

The apparent consumption of implantable medical devices, materials and support equipment in Brazil increased by 7.8% in 2018, demonstrating the re-covery of the sector in relation to the last years.

There was a fall in the share of imports from the apparent consumption from 43% in 2012 to 35% in 2018, indicating the growth of national production in the period.

Percentage share of imports in the apparent consumption of implantable medical devices, materials and support equipment.Share of imports in % apparent consumption in US$ million

1Apparent consumption: sum of domestic production and imports less exports.8The Alice Web system has been deactivated and replaced by the Comex Stat.

Source: SECEX – Alice Web Comex Stat8 ; IBGE/PIA PRODUTO 2016.

2,554

43% 42%

39%36%

34% 34% 35%2,849

3,039

2,8192,778

2,735

2,950

2012 2013 2014 2015 2016 2017(P) 2018(P)

Apparent consumptionImports/apparent consumption

50%

45%

40%

35%

30%

25%

20%

10%

15%

0%

5%

GRAPH 21


Source: Comex Stat

COSTA RICA 3.4%

3.4%INDIA

4%

PUERTO RICO

FRANCE

5.4%

SWITZERLAND 5.5%

CHINA 6.7%

IRELAND 6.8%

GERMANY 10.4%

OTHER COUNTRIES 17.3%

UNITED STATES 32.7%

MEXICO

4.3%

2018 - TOTAL: US$1.03 BILLION

Main countries of origin of implantable medical devices, materials and support equipment imports. In % of US$ - 2017 and 2018

GRAPH 22

In 2018, US$1.03 billion was invested in implantable medical devices, ma-terials and support equipment, equivalent to 16,083 tons.

The United States was the main country of origin of imports, representing 32.7% of the total in 2018. In addition to Germany and Ireland, these countries accounted for 50% of Brazilian imports.

The 10 largest countries of origin of imports together accounted for 82.7% of imports.

COSTA RICA 2.9%

3%JAPAN

3.1%

PUERTO RICO

FRANCE

4.5%

SWITZERLAND 5.4%

CHINA 6.3%

IRELAND 7%

GERMANY 9.5%

OTHER COUNTRIES 15%

UNITED STATES 39.1%

INDIA

4.2%

2017 - TOTAL: US$936 MILLION



TABLE 01

Main countries of origin of imports of implantable medical devices, by product - 2018.9 By product – 2018

Source: Comex Stat.

9Does not include materials and support equipment.

30061090 97Other sterile catheters,ect, for surgical sutures Ireland 42 43%

90211020 42Articles and appliances for fractures Costa Rica 16 38%

90213930 31Prostheses of coatedvascular arteries United States 16 53%

90189095 88Clips, their applicatorsand extractors United States 46 52%

90213110 39Femoral joint prostheses United States 18 47%

90213980 28Other articles andappliances for prosthesis United States 11 38%

90211010 81Orthopedic appliances Puerto Rico 45 55%

90213920 36Intraocular lenses Switzerland 9 25%

90213190 37Other joint prostheses United States 17 46%

90219081 28Stents, whether or not mounted on a balloon catheter United States 12 43%

NCMCODE

TOTAL IMPORTEDIN US$MILLIONS

NCMDESCRIPTION

MAIN COUNTRY OF ORIGIN

INUS$MILLION

COUNTRY TOTALPART. %

CERTAIN PRODUCTS AND TECHNOLOGIES ARE ONLY AVAILABLE IN BRAZILIAN HEALTH THROUGH IMPORTS.


Source: Comex Stat

SPAIN 3%

3%PUERTO RICO

4%

ARGENTINA

COSTA RICA

5%

COLOMBIA 6%

MEXICO 10%

SWITZERLAND 11%

BELGIUM 11%

UNITED STATES 19%

OTHER COUNTRIES 23%

CHILE

5%

2018 - TOTAL: US$ 237 MILLIONS

Main destination countries for exportsof implantable medical devices,materials and support equipment.In % of US$ millions

GRAPH 23

In 2018, US$237 million were exported in implantable medical devices, ma-terials and support equipment, equivalent to 1,702 tons.

The United States was the main export destination, representing 19% of the total in 2018. In addition to Belgium and Switzerland, they accounted for 41% of exports.

The 10 largest export destinations together represented 77% of Brazilian exports.

PUERTO RICO 2.5%

3%COSTA RICA

3.4%

COLOMBIA

CHILE

5.3%

ARGENTINA 5.7%

SWITZERLAND 7.5%

MEXICO 10.3%

BELGIUM 10.8%

OTHER COUNTRIES 19.8%

UNITED STATES 28.1%

SPAIN

3.7%

2017 - TOTAL: US$ 258 MILLIONS


Between 2017 and 2018, exports of medical devices, materials and support equipment declined.

TABLE 02

Main destination countries for exports of implantable medical devices, by product - 2018.10 By product – 2018

Source: Comex Stat.

10Does not include materials and support equipment.

30061090 59Other sterile catheters,etc., for surgical sutures Belgium 16.8 28.4%

90213980 9Other articles andappliances for prosthesis Mexico 1 11.1%

90189095 2Clips, their applicatorsand extractors United States 0.3 14.8%

90211010 57Orthopedic appliances Switzerland 8 14%

90213190 5Other joint prostheses France 0.9 16.7%

90213920 2Intraocular lenses United Sates 0.2 12.9%

90213930 27Prostheses of coatedvascular arteries

Nederland 1.1 4.2%

90213110 5Femoral joint prostheses France 0.7 13.9%

90211020 5Articles and appliancesfor fractures

Ecuador 0.8 16.6%

90219081 1Stents, whether or not mounted on a balloon catheter

Nederland 0.2 19.7%

NCMCODE

TOTALEXPORTEDIN US$MILLION

NCMDESCRIPTION

MAIN DESTINATION COUNTRY

INUS$MILLION

COUNTRY TOTALPART. %

3Comparative price analysis of implantable medical devices in selected countries

3. COMPARATIVE PRICE ANALYSIS OF IMPLANTABLE MEDICAL DEVICES IN SELECTED COUNTRIES

65THE CYCLE OF THE SUPPLY OF HEALTH PRODUCTS IN BRAZIL64

Initially, we describe the functioning of the market for implantable medical devices, from the point of view of the industrial organization, putting in perspective the structure and conduct issues of this sector, pointed out in the previous chapters and organized here in the SCP (Structu-re-Conduct-Performance) to then insert the rich debate on the issue of technologies and prices in this context.

Following, we present a comparison of ave-rage prices, between countries of Europe, Latin America and the United States, of two different medical devices widely used in the Brazilian pu-blic and private systems, obtained through secon-dary database query.

In this chapter, we aim to deepen the knowledge and verify the veracity of some arguments that have been used in discussion forums on the most va-ried topics related to the health sec-tor, in which the prices of implanta-ble medical devices started to serve as villains to justify readjustments of throughout the industry.

ABRAIDI seeks to contribute to the discussion by bringing unpublished Brazilian data on average prices in several countries.

In the end, we present our conclusions in the face of the debate on the prices of medical devices and their impact on health costs.

With this, ABRAIDI seeks to contribute to the discussion, bringing new data in Brazil on average prices of products in several countries of the world and establishing a comparison.

COMPARATIVE PRICEANALYSIS OF IMPLANTABLE MEDICAL DEVICES IN SELECTED COUNTRIES

* The government also plays a key role in this market by regulating the interaction between the agents and the introduction of new pro-ducts, guaranteeing the patient’s safety in their use, as well as being a demander and purchaser, so that these products are available to patients who resort to the public health system - Sistema Único de Saúde (SUS).

We will briefly describe, without attempting to exhaust the discussion, the main aspects of this market in light of the framework of indus-trial organization theory, first developed by Joe Staten Bain in the 1950s, and improved by se-veral succeeding authors. This analysis helps to understand the complexity of the interactions

THE MEDICAL DEVICE MARKETAND ITS PRICE DYNAMICS

that occur in an industry, by separating its cha-racteristic elements such as: structure, conduct and performance (SCP).

The SCP paradigm was initially defined in Bain’s (1967) book entitled Industrial Organi-zation. According to this paradigm, structural aspects of industry, notably: concentration of firms, barriers to entry and economies of scale influence prices. Performance refers to technical efficiency, the relationship between long-term prices and costs, size, growth capacity and, last but also important, the social progress derived from these market dynamics.

The medical devices market represents an important and growing part of the health products industry. The interaction between manufacturers, importers, distributors, hospitals, professionals, health insurances, and patients has a direct impact on the performance of this sector, as well as the prices of products and services.

*


663. COMPARATIVE PRICE ANALYSIS OF IMPLANTABLE MEDICAL

DEVICES IN SELECTED COUNTRIES

67THE CYCLE OF THE SUPPLY OF HEALTH PRODUCTS IN BRAZILTHE CYCLE OF THE SUPPLY OF HEALTH PRODUCTS IN BRAZIL

Representation of the StructureConduct-Performance Paradigm.

Source: Scherer & Ross (1990).

BASIC CONDITIONS

MARKET STRUCTURE

number of buyersand sellers

product differentiation

barriers toentry and exit

vertical integration diversification

cost structures

CONDUCTpricing

research anddevelopment

product and advertisement strategy

capacity expansion

institutional strategies

PERFORMANCE

productive andallocative efficiencyfull employment equity

SUPPLY

Raw material

weight/valueinstitutional environment

product perishabilitytechnology

DEMAND

growth ratesubstitutes

seasonalitypurchase methodtype of marketing

elasticity

economicdevelopment

FIGURE 12

In the case of the medical devices sector, the structure of the sector has the following main characteristics:

The production of implantable medical de-vices in the areas of cardiology, orthopedics, etc. is restricted to just over two dozen manufactu-rers worldwide.

The Brazilian distribution network in the health area includes products such as: me-dicines, medical equipment, equipment, implantable medical devices, among others, distributed from North to South of the coun-try, with characteristics of small and medium enterprises.

Thus, the structure of a sector refers to the organizational characteristics of companies that influence the nature of competition and prices within a given market.

In this case, the number of firms, their relative size, the degree of market concentration, barriers to entry, such as access to distribution channels, institutional barriers, transaction costs and poten-tial competition, affect the possibility of firms raise their prices above average costs without attracting competition11.

The market structure still takes into account the differentiation of products, that is, the capacity to introduce a new commodity that has the cha-racteristic of being substitute next to another one previously produced.

Productive and allocative efficiency is one of the sector’s performance indicators.

The network of hospitals in Brazil consists of 6,805 units with 596,186 beds, of which 44.3% are private and 55.7% are public.

There are 769 operators, insurers and heal-th plans with active registration in Brazil, accor-ding to ANS12.

In some regions of the country, few hospi-tals and/or insurers act and exercise local pur-chasing power by defining conditions and rules for the purchase of products (oligopsony).

11 Coase (1993) and Williamson (1999).

12 Operators with active registration - ANS Tabnet. Available at: <http://www.ans.gov.br/profile-of-sector/data-and-sector-indicators>. Accessed on: March 26, 2019.

PLAYERS’ CHARACTERISTICS:

*





Macroeconomic healthdata in Brazil - 2018.

Sources: Medical Demography in Brazil 2018, research conducted by the School of Medicine of the University of São Paulo (FMUSP) with institutional collaboration of the Federal Council of Medicine (CFM) and the Regional Council of Medicine of São Paulo (Cremesp); Federal Nursing Council (Cofen); Focus Market Report, released by the Central Bank (BC); National Supple-

mentary Health Agency (ANS); Brazilian Institute of Geography and Statistics (IBGE); National Register of Health Establish-ments (CNES); Federation of Hospitals (FBH). Figure taken from the site:

<https: //www.hospitalar. with/en/o-event/health-sector>. Accessed on: March 26, 2019.

9,1% of GDP 496,073 nurses

21.325laboratories

22.5% of the population

has healthinsurance

435,098 physicians

209 millions inhabitants

312.622health facilities

6,805hospitals

596,186hospital beds44.3% privateand 55.7% public

average life expectancy of75.8 years(72.9 for men / 79.4 for women)

FIGURE 13

The process of innovation occurs in two stages, a first, called disruptive, when a totally innovative product is developed. This new pro-duct continues to be considered innovative for a short time, which in this sector is around four years, that makes it difficult to deposit patents. In the second stage, from then on, the techno-logical evolution occurs from improvements in the initial version and becomes incremental.

BETWEEN MARKET STRUCTUREAND PERFORMANCE, THE CONDUCTOF COMPANIES IS FOUND

The industry offers a wide range of products that have technological distinctions. The quality of medical devices needs to be ensured and re-quires the availability of information about the safety, effectiveness, validity and performance of the product, making monitoring of its use permanent.

The barriers to entry of new manufactu-rers, importers and distributors in this market are relatively high due to the complexity of the industry. The fulfillment of the stages and the level of technical requirement of information

throughout the process of approval of the re-gistration of products require extreme qualifica-tion of the professionals involved, and demand very high investments.

BARRIERS TO COMPETITORS ENTRY

CHARACTERISTICS OF THE PRODUCTSAND THEIR RESPECTIVE INNOVATION PROCESS

The conduct refers to the behavioral patterns that companies adopt to adjust to the market, in order to obtain better levels of performance (LEITE, 1998). They encompass the various strategies, such as occupying market niches, decisions to centralize production, product characteristics, selling expenses, and research and development (R&D) expenditures.

In the case of the medical device sector, the following conduits may be highlighted.





perception of what the value of the product and what the value of the product added to the abo-ve services (expanded product).

Often a certain technology becomes tech-nically unfeasible due to the low demand, since the indication is extremely specific, thus making the procedure cost high despite the high reso-lution.

Hospitals, health plans, insurance compa-nies and the SUS (paying agents) pay directly for the acquisition of the device to manufacturers or distributors. Prices for many hospital proce-dures already include the use of medical devices and are predefined in reimbursement tables.

In cases where health plans pay directly to distributors for the acquisition of the devices, the hospitals have been remunerated by the operators through a commercialization fee.

The high complexity medical devices are priced by the Ministry of Health, in an environ-ment of chronic difficulties of financing the SUS and with great technological and administrative

CONDUCT OF PAYING AGENTSAND COSTS OF TRANSACTION

barriers to the exclusion of products or the in-clusion of new products and even the revision of prices. On the whole, it is a very outdated ta-ble, with occasional changes. In this system, the highlight is the scope of the SUS, with a popula-tion of 209 million potential citizen-users.

The rule is a system that demands a very high cash volume, with delays in billing, very high payments, delays, disallowances and dis-counts that disproportionately increase the transaction costs of the chain.

The complexity of certain products, the in-vestment made and the demand for each spe-cialty are directly linked to the actual cost to the market.

RELATIONSHIP BETWEEN THE PRICEDYNAMICS AND THE INNOVATION PROCESS

The existence of often unpaid services such as logistics, the availability of instruments, equi-pment, instrumentation and sterilization make the final value of products and services or the

DIFFICULTY OF APPROPRIATION OF DIRECTAND INDIRECT COSTS IN THE VALUATIONOF PRODUCTS AND SERVICES

of distributors more dependent on tax exemptions and the private market.

In addition, the public system fails to ade-quately compensate for these technologies, limiting the population’s access to “edge” pro-ducts, making one of the alternatives the judi-cialization.

The freezing of readjustments in me-dical device reimbursement tables in the SUS makes the financial performance

The process of incorporating new technolo-gies into the public system is bureaucratic and time-consuming, on the back of political issues, and is also constrained by ever-increasing pres-sures on costs.

FAIR REMUNERATION

ACCESS AND WELFARE

As a result of the interaction between market structure and conduct, one has the performance of one sector. In the case of the medical device sector, its performance is reflected in the popu-lation’s access to products, in the results of com-panies operating in this market, in their ability to innovate permanently and in the market percep-tion of the value of the medical device that is offe-red. In this sense:

Therefore, supply characteristics (technology, product type, actors, etc.) and the demand for medical devices have an impact on the performance, structure and conduct of the industry. Public policies or government actions (regulations, taxes, investment incentives, etc.) also directly or indirectly affect the industry. *

The freezing of readjustments on medical device reimbursement tables in the SUS makes the financial performance of distributors more dependent on tax exemptions.



ANALYSIS OF PRICE DEVELOPMENTSOF SELECTED PRODUCTS

For the present analysis, two products were selected as market flags. In the area of cardiology, coronary stents are the first item in the SUS me-dical devices table, in value. It is estimated that the same situation is mirrored in the private health sector.

In the orthopedic sector, total knee prostheses, although not among the five largest expenses of the SUS with medical devices (the fifteenth) have been stigmatized in the last five years as a negative example and overcome distortions in the SUS, but mainly in the Supplemental Health System (Tables 3 and 4).

Methodology of product selection and data collection

*

For the present analysis, two products were selected as market flags: the coronary stent and the total knee prosthesis.

TABLE 03

Twenty major medical devices purchased by SUS in 2018 in total purchase amounts. – in R$

Source: InfoABRAIDI/Datasus

TOTAL REPORT (AS A FILTER)

TOP 20 – MEDICAL DEVICES

Coronary artery stent

Multiprogrammable dualchamber cardiac pacemaker

Pharmacological Stent for Coronary Artery

Extracorporeal circulation set (adult)

Catheter Balloon for percutaneoustransluminal angioplasty

Implantable cardioverter defibrillator

Shear Linear Stapler

Pedicular devices for rodattachment (includes blocker)

Cardioverter defibrillatorwith multi-site pacemaker

Definitive Endocardial Electrode

Titanium plate mini/microfragments system (includes screws)

Aortic/tubular aortic endoprosthesis

Prosthesis for multichannel cochlear implant

Dirigible guide wire for angioplasty

Stent for peripheral artery

Multiprogrammable uniquechamber cardiac pacemaker

Disposable centrifugal pump for use in extracorporeal and/or assisted circulations

Prosthesis for multichannel cochlear implant

Bifurcated aortic endoprosthesis

Guide catheter for percutaneoustransluminal angioplasty

Total:

Total:

0702040533

0702040410

0702040614

0702040193

0702040088

0702040061

0702050288

0702050822

0702040045

0702040240

0702050482

0702040290

0702090093

0702040380

0702040517

0702040428

0702050016

0702090034

0702040282

0702040134

2631552

748049

79911

18228

36513

36415

93528

1248

42502

70298

700

32023

68938

2436

556

121252

10752

4931

27451

440

1377

98550

533.97

1,130.48

2,034.50

5,225.55

2,034.50

1,581.63

500.00

36,089.38

1,033.00

500.00

50,000.00

973.70

361.81

10,200.00

43,830.15

195.45

2,034.50

4,324.34

729.56

43,830.15

14,000.00

195.45

1,405,159,629.23

845,651,652.97

162,578,929.50

95,245,857.00

74,285,698.50

57,595,056.45

46,764,000.00

45,039,546.24

43,904,566.00

35,149,000.00

35,000,000.00

31,180,795.10

24,942,457.78

24,847,200.00

24,369,563.40

23,698,703.40

21,874,944.00

21,323,320.54

20,027,151.56

19,285,266.00

19,279,000.00

19,261,597.50

28.4

3

0.7

1.4

1.4

3.6

0.0

1.6

2.7

0.0

1.2

2.6

0.1

0.0

4.6

0.4

0.2

1

0.0

0.1

3.7

60.2

11.6

6.8

5.3

4.1

3.3

3.2

3.1

2.5

2.5

2.2

1.8

1.8

1.7

1.7

1.6

1.5

1.4

1.4

1.4

1.4

Material (medical device) Code Quant. Total Value%* %*Average Value

Emission Distribution of the 20 medical devices, according to the value of SUS

26/02/2019Filtersused Period: 01/2018 to 12/2018, Brazil





TABLE 04

Twenty major medical devicespurchased by the Private Systemin 2012 in total purchase amounts.

Source: ANS, 2015. Excerpted from the Final Report of the Interinstitutional Working Group on Orthoses, Prosthetics and Special Materials (GTI-OPME). Available at: <http://portalquivos.saude.gov.br/images/pdf/2015/july/07/Relatorio-Final-versao-

final-6-7-2015.pdf>. Accessed on: 26 Mar. 2019.

Medical devices

Covered C-P Stent

Kit for bariatric surgery (video)with Loads (unit med: und)

Acts

Liberté monorail 12mm x 2.5mmCoronary stent system

Total knee prosthesis B2C AE 600

Dexamet drug-eluting stent

Hip prosthesis Cutting linear stapler

Board

Surgical screw

Stent color biomatrix

Chromium-cobalt coronary stent coated with Everolimus Xience V / Promus (Unid. med: unid)

Promus coronary stent (Unid.med: unid)

Zenith Endoprosthesis 24x96 Bifurcated

Micro spring cerebral aneurysm goc 10 30 4x6

Screw Ped. Polyaxial

Pacemaker at 501 double chamber

Polaxial SFS screw (Unid.med:unid)

Pedicle screw

R$ 12,829,197.18

R$ 10,725,254.23

R$ 5,876,069.30

R$ 5,526,191.58

R$ 4,402,854.00

R$ 3,899,836.77

R$ 3,500,507.00

R$ 3,412,552.54

R$ 3,261,700.14

R$ 2,860,462.28

R$ 2,749,175.90

R$ 2,433,736.91

R$ 2,377,985.40

R$ 2,273,472.00

R$ 2,140,002.19

R$ 2,098,545.60

R$ 2,070,493.46

R$ 1,953,900.00

R$ 1,930,375.75

100

6.4

5.3

2.9

2.8

2.2

1.9

1.7

1.7

1.6

1.4

1.4

1.2

1.2

1.1

1.1

1.0

1.0

1.0

1.0

100

6.4

11.7

14.7

17.4

19.6

21.6

23.3

25.0

26.6

28.1

29.4

30.6

31.8

33.0

34.0

35.1

36.1

37.1

38.0

ITEM EXPENSES % ACCUMULATED %

GRAND TOTAL Bifurcated endoprosthesis

Long trocar w/ pta.piramidal w/ sheath tp. diaphragm (obesity) 14.1444

Screw

Endoprosthesis A A.T. Relay 32mm x 15mm 23f

Versapoint bipolar electrode of the resectospio system

Pharmacological Stent coated endeavor

Equine intrafix primeline air il 401450p

Pharmacological Stent

Lumax 300 bicameral cardio-defribillator

Cardio-defribillator with ressincrinizator lumax 540 HF-T

Stent taxus express

Orthopedic cotton 12cm x 1mt super white ho312

Prot. Lig. cervical disk

Endoprosthesis

Asnis III Paraf TI06 5 x 40 mm Total Sterile Thread

Cage in peek

Micro stent system introd 2.5x15mm neuroform 3

Charge endo gia* II 30-35 mm

Knc6oxl Cholecystectomy Kit

Asnis III Paraf TIO8.0 x 45 mm Total Sterile Thread

R$ 1,812,053.80

R$ 1,731,628.00

R$ 1,633,051.76

R$ 1,630,200.00

R$ 1,630,943.20

R$ 1,538,660.00

R$ 1,440,407.38

R$ 1,361,338.45

R$ 1,360,179.00

R$ 1,311,842.94

R$ 1,259,848.40

R$ 1,224,548.32

R$ 1,170,354.28

R$ 1,142,262.74

R$ 1,112,740.95

R$ 1,080,701.78

R$ 1,060,555.00

R$ 1,042,420.00

R$ 1,004,848.00

R$ 1,004,276.52

0.9

0.9

0.8

0.8

0.8

0.8

0.7

0.7

0.7

0.7

0.6

0.6

0.6

0.6

0.6

0.5

0.5

0.5

0.5

0.5

38.9

39.8

40.6

41.4

42.2

43.0

43.7

44.4

45.1

45.7

46.4

47.0

47.6

48.1

48.7

49.2

49.8

50.3

50.8

51.3

ITEM EXPENSES % ACCUMULATED %



The average sales prices were analyzed in countries of Europe, Latin America and the United States, between 2014 and 2018

Primary total knee prosthesis (NCM: 9021.31.10 Joint femoral prostheses. The name for this product is total knee prosthesis, corres-ponding to the medical-surgical procedure of the total primary knee arthroplasty and, roughly, in-volves the sum of four components).

DESCRIPTION OF SELECTED PRODUCTS

Coronary stents (NCM: 9021.90.81 Expandab-le implants (stents), even mounted on a balloon catheter).

DATA COLLECTION

The average market prices in the countries analyzed were obtained by consulting the secon-dary database of Decision Resources Group – Mil-lennium Research Group, for the same products surveyed in Brazil, Argentina, Colombia, Mexico, the United States and in some European coun-tries 13.

For US product data, DRG searches for databa-ses, hospital purchase order prices for more than 1,600 hospitals in the United States. As a result, the average selling prices of “average sale prices” (ASPs), similar to the data obtained for Brazil, were provided.

The methodology for obtaining annual avera-ge price data in the analyzed countries was descri-bed by DRG as follows:

UNITED STATES

DRG obtains data from the following real--world sources to identify rates of device use and procedures in the hospital environment:

internal databases, with data from the Centers for Medicare and Medicaid Services (CMS) relating to insurance claims;

private payer (business insurance) data on the level of claims and site service data at the level of claims;

13International data provided for Drug Eluting Stent (DES); Bare-Metal Stent (BMS) and international data provided on primary TKA or primary total knee replacement

purchase data from live hospitals, which are used to identify sales data (units sold, sales price, etc.);

field surveys in the United States for several active catheterization laboratories in different sta-tes, where procedural and sales data are obtained;

interviews with physicians to identify the use of devices and the trends of procedures, usually in larger centers.



EUROPE

DRG used the following data sources to iden-tify volumes of procedures within the hospital setting:

internal databases with procedure code volu-me information at the installation level within the five largest European countries: France, Germany, Italy, Spain and the United Kingdom;

publicly available national registration data;

LATIN AMERICA

the methodology used in the countries analy-zed consists of research sent to hospitals to obtain data on the purchase processes by insurers and hospitals and sales;

ongoing field surveys in European nations for several active catheterization laboratories, where data on procedures and sales are obtained;

interviews with physicians to identify the use of devices and the trends of procedures, usually in larger centers.

interviews with physicians to identify device usage and procedural trends.

The annual average values were obtained in public secondary bases of international listin-gs. The studies used preserve the secrecy of the source and work with anonymized data, thus following the best international practices of com-pliance in the use of data.

The data obtained refer to the period 2014-2018.

The studies usedpreserve the secrecy of the source and work with anonymized data, thus following the best international practices of compliance in the use of data.

*

DEVELOPMENTS OF MEDICALDEVICES MARKETING PRICESIN THE COUNTRIES ANALYZED

The final product marketing prices include margins of profitability and the additional amou-nts needed to remunerate the labor allocated to its technical sales, distribution and logistics struc-ture, and the innumerable inefficiencies of the Brazilian health system, such as taxes, services that are not remunerated, disallowances, imposi-tion of discounts, withholdings and delays in pay-ments made by paying agents.

In the exposition on “The market for implantab-le medical devices and their price dynamics” we have already referred to the question of the relation be-tween price and technology in this sector, where we highlight the fact that prices of innovative pro-ducts are higher at the time and then decay when the product reaches a certain maturity. National and international data attest to this.

Let’s look at the price data for these two pro-ducts. *

The prices of innovative products are higher at the time of launch and then decline when the product reaches a certain maturity.





Coronary stents were developed in the mid-1980s and have, since then, undergone major refinements in design and composition.

According to Iqbal (2013) “Coronary stents were developed in the mid-1980s and have, since then, undergone major refinements in design and compo-sition.”

The initial metal stents, used until the late 1990s, had high metal density, resulting in a high incidence of subacute stent thrombosis (ST), and were bulky and technically difficult to use, resul-ting in frequent implantation failure and em-bolization. These stents were generally made of stainless steel, which is biologically inert. In recent years, there have been significant refinements in the material and design of metal stents. In the current generation of stents, chromium-cobalt and nitinol (nickel alloy and titanium) alloys have replaced steel, allowing newer stents to be desig-ned with significantly thinner structures without compromising radial strength or corrosion resis-tance.

The development of drug-induced coronary stents was a reversal in interventional cardiology. The stents were then coated with drug-impreg-nated polymers, which are released slowly over a few weeks after stent implantation. Eduardo

The first question to be raised is to define the timeline of when the coro-nary stent was introduced in the international market and could be con-sidered a “disruptive” innovation, and if when it came to be considered a product that reached its technological maturity to, after that, analyze the evolution of their prices.

TECHNOLOGICAL EVOLUTION OF CORONARY STENTS

Sousa implanted the first stent eluted from siroli-mus in 1999. And this stent became available for clinical use in 2002-2004. Since 2002, a variety of immunosuppressive and antiproliferative agents have been tested and the types of “limus” drugs have shown real efficacy in clinical practice. The polymers used in the manufacture of these stents have also evolved greatly.

The search for the ideal stent continues, but there may not be a single stent suitable for all patients and all injuries. Interventional cardio-

The search for the ideal stent continues, but there may not be a single stent suitable for everyone.

NON-DRUG CORONARY STENT PRICES IN THE COUNTRIES ANALYZED

logists in the future will have a wide variety of stents available, which may allow the practice of personalized, evidence-based medicine, in which the choice of stent is based on genetic determi-nants, risk profile (for restenosis, thrombosis and bleeding) and characteristics of the stent. injury of patients.

In Brazil, the first stents with drugs based on sirolimus (Cypher) and paclitaxel (Taxus Express) were approved by Anvisa in 2003.

From 2003 to 2005, the use of stents with drugs increased significantly. In the 2004-2005 biennium, approximately 14% of percutaneous coronary interventions (PCI) included the implan-

Table 5 shows the mean annual prices of drug-free stents paid by hospitals in Latin Ame-rican countries, in the United States, and in Eu-ropean countries, in dollars.

In all countries there was a fall in the prices of these stents. The sharpest drop oc-curred with stent prices in Spain, France and Italy. It should be noted that the prices practi-ced in Brazil are lower than those practiced in the United States, similar to those practiced in

tation of an stents with drugs And only in 2014 the Ministry of Health included the treatment with pharmacological stent in the SUS for patients with coronary artery disease.

France and lower than the average values prac-ticed in Mexico.

The average values of the Brazilian market vary or are impacted by the price practiced by the SUS table. The little use in supplementary health causes the prices of this product to fall to an approximate level of the lowest internatio-nal prices, once it has been technically replaced by the drug eluting stent.

*

*





United Kingdom $ 237.83$ 255.84 $ 222.82 $ 210.51 $ 200.54 - 21.6%

Argentina $ 133.03$ 135.94 $ 130.28 $ 127.68 $ 125.21 - 7.9%

Spain $ 1,062.12$ 1,203.27 $ 944.53 $ 848.07 $ 769.95 - 36%

Brazil $ 597.23$ 642.36 $ 556.50 $ 519.85 $ 486.96 - 24.2%

USA $ 715.58$ 716.47 $ 713.24 $ 707.53 $ 694.94 - 3%

Mexico $ 742.94$ 782.02 $ 706.01 $ 671.34 $ 639.02 - 18.3%

TABLE 05

Annual average prices for non-drug-elutingstents (bare metal) paid by health careproviders or hospitals in Latin Americancountries, the United States, and European countries, in US dollar from 2014 to 2018.In US$, from 2014 to 2018Source: DRG © 2019 Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publica-

tion prohibited. Reprinted with permission. Table prepared by Websetorial.

Germany $ 117.47$ 123.33 $ 112.58 $ 108.58 $ 105.34 - 14.6%

Italy $ 355.74$ 387.64 $ 329.16 $ 307.37 $ 289.71 - 25.3%

Colombia $ 442.74$ 466.88 $ 419.91 $ 398.49 $ 378.52 - 18.9%

France $ 570.59$ 628.89 $ 522.03 $ 482.19 $ 449.93 - 28.5%

COUNTRY 20152014 2016 2017 2018VARIATION2018/2014

Source: DRG © 2019 Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publica-tion prohibited. Reprinted with permission. Chart prepared by ABRAIDI.

Annual average prices for non-drug-elutingstents (bare metal) paid by health careproviders or hospitals in Latin Americancountries, in the United States, and in European countries, in US dollar from 2014 to 2018.In US$, from 2014 to 2018

12000 200 800600400 1000

SPAIN

UNITEDKINGDOM

ITALY

USA

ARGENTINA

BRAZIL

COLOMBIA

MEXICO

FRANCE

GERMANY

2014 20162015 2017 2018

GRAPH 24



Table 6 shows the average annual prices paid by hospitals in Latin American countries, in the United States, and in European countries, in dollars.

In all countries there was a fall in stent pri-ces.. The sharpest drop occurred with stent prices in Spain, Argentina and Colombia. It is worth noting that the prices practiced in Brazil are similar to tho-se practiced in Spain and are lower than the avera-ge values practiced in Mexico and Colombia

.

PRICES OF CORONARY STENTS WITHDRUGS IN SELECTED COUNTRIES

In all countries there was a fall in stent prices.

*

United Kingdom $ 560.56$ 583.23 $ 537.89 $ 515.75 $ 494.60 - 15.2%

Argentina $ 574.66$ 611.16 $ 541.12 $ 510.44 $ 482.50 - 21.1%

Spain $ 1,404.70$ 1,487.06 $ 1,322.34 $ 1,241.91 $ 1,165.09 - 21.7%

Brazil $ 1,481.90$ 1,570.87 $ 1,397.80 $ 1,318.87 $ 1,245.28 - 20.7%

USA $ 1,243.20$ 1,316.59 $ 1,173.86 $ 1,108.34 $ 1,046.44 - 20.5%

Mexico $ 1,635.97$ 1,711.92 $ 1,564.17 $ 1,496.79 $ 1,433.97 - 16.2%

TABLE 06

Annual average prices for drug eluting stents paid by health care insurances or hospitals, in Latin American countries, in the United States and in European countries, in US dollar, from 2014 to 2018.In US$, from 2014 to 2018Source: DRG © 2019. Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publica-

tion prohibited. Reprinted with permission. Table prepared by Websetorial.

Germany $ 239.87$ 246.85 $ 232.89 $ 226.08 $ 219.57 - 11.1%

Italy $ 717.80$ 750.46 $ 685.14 $ 653.24 $ 622.78 - 17%

Colombia $ 1,578.12$ 1,674.24 $ 1,487.25 $ 1,401.97 $ 1,322.47 - 21%

France $ 988.13$ 1,041.20 $ 935.04 $ 883.21 $ 833.70 - 19.9%

20152014 2016 2017 2018COUNTRYVARIATION2018/2014





Source: DRG © 2019. Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publi-cation prohibited. Reprinted with permission. Chart prepared by ABRAIDI.

Annual average prices for drug eluting stents paid by health care insurances or hospitals in Latin American countries, in the United States, and in European countries, in US dollar from 2014 to 2018.In US$, from 2014 to 2018

1200600 800 1400400200 1000 16000

SPAIN

UNITEDKINGDOM

ITALY

USA

ARGENTINA

BRAZIL

COLOMBIA

MEXICO

FRANCE

GERMANY

2014 20162015 2017 2018

GRAPH 25

The search for the means of overcoming this disability resulted in the development of surgical techniques and materials that minimally could restore the function of the knee joinT.

TECHNOLOGICAL EVOLUTION OF KNEE PROSTHESES

The indications for the installation of these implants are mainly degenerative diseases that destroy this joint, but also infections, oncological diseases and trauma. The result of chronic arthri-tis is a process of pain and impairment of move-ment, disabling the patient progressively for the simplest and basic activities, such as sitting and standing, walking, doing personal hygiene, and harms the life of relationship.

The search for the means of overcoming this disability resulted in the development of surgical techniques and materials that minimally could restore the function of the knee joint, with all its complexity, involving movements (flexion-exten-sion, rotation, self-locking), loads, fixation of the components , biocompatibility, wear and infec-tions.

Still in the 19th century attempts were made

The knee prosthesis replaces the joint surface of the femur and the tibia with a metal component and a set of two parts, one plastic and one metal, respecti-vely. Depending on each case, a fourth element, the patella, is included with the same materials.

to use various materials such as ivory and human tissues, even animals, in a pioneering and artisanal way, with very restricted results.

The most solid progress came in the second half of the twentieth century, dominating the industrial processes of metallurgy and polymer development, at the service of doctors, engineers, designers and numerous other specialists.

The first prostheses were in stainless steel, still used, but currently, chromium-cobalt alloys have been preferred, which are more resistant to wear and produce less waste, which is responsible for the detachments and poor results of the prostheses, together with inadequate surgical technique and co-morbidities.

Titanium alloys are also used for the metal tibial component. The elasticity of titanium over steel is closer to bone, which reduces the risk of bone resorption around the prosthesis. However, titanium and





its alloys should not be used on surfaces subjected to friction and the release of waste, as mentioned above.

The materials constituting the sliding contact surfaces must be chosen because of the greater or lesser release of particles by the wear that occurs there. As an example, problems recently released with metal-to-metal joints, releasing chromium into the bloodstream, with cancer risk and into-xication. Therefore, the other tibial component, which will support the femoral component, is almost always made of polyethylene.

This is where most of the development efforts are concentrated, with sophisticated studies of the molecular nature of polymers, physio-chemical studies and prolonged tests to analyze wear, simu-lating knee biomechanics - flexion-extension, rota-tion, load bearing - simulating incredible human experience of ten or fifteen years of continuous use. In the laboratory, sophisticated machines perform repetitive movements for weeks to predict wear and tear on humans. Initially 5 million cycles were done, but with the need to have more durable pro-ducts, the tendency is to extend these tests to 10 million cycles, considering the duration of prosthe-ses for twenty years or more.

Wear studies are made for both metals and polyethylene. They are a branch of science called tribology and require multiple complementary laboratories, equipped with precision equipment, electron microscopes and scanning, mass spec-trophotometry, X-ray equipment and dozens of others.

However, equipment, software and metrolo-gical and quality efforts only work and are justi-fied when serving multi professional teams. High technology in this industry relies on engineers, chemists, physicists, designers, data analysts, and IT specialists, all working collaboratively with or-thopedic surgeons at universities and major refe-rence centers.

Finally, it is important to mention that althou-gh the focus is on the implant, the instrumental set necessary for its installation plays a funda-mental role in the result, since it guides the good hands of the well trained surgeon in the plans and in depths appropriate to the implant good long-term result. Therefore, knee prosthesis is not a “tweak”.

PRIMARY TOTAL KNEE PROTHESISPRICES IN THE COUNTRIES ANALYZED

Table 7 presents the average annual prices paid by hospitals and insurers of primary total knee replacements in Latin American countries, the United States and European countries, in dollars.

In all countries there was a slight decrease in the prices of primary total knee replacements. The sharpest drop occurred in the United States, where the average values are much higher than those practiced internationally. It is worth noting that the prices practiced in Brazil are similar to those practiced in Europe, with the exception of Germany.

*

*

TABLE 07

Average annual prices of primary total knee replacements paid by health care insurances or hospitals, in Latin American countries, in the United States, and in European countries, in US$, from 2014 to 2018.In US$, from 2014 to 2018

Source: DRG © 2019. Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publi-cation prohibited. Reprinted with permission. Table prepared by Websetorial.

United Kingdom $ 2,274.9$ 2,290.7 $ 2,258.6 $ 2,242.0 $ 2,224.9 - 2.9%

Argentina $ 2,240.3$ 2,244.0 $ 2,236.0 $ 2,230.8 $ 2,224.5 - 0.9%

Spain $ 2,139.5$ 2,154.2 $ 2,108.3 $ 2,091.9 - 2.9%

Brazil $ 2,148.0$ 2,151.8 $ 2,143.5 $ 2,138.0 $ 2,131.4 - 0.9%

USA $ 4,387.2$ 4,496.0 $ 4,280.3 $ 4,175.8 $ 4,074.1 - 9.4%

Mexico $ 862.7$ 867.6 $ 857.1 $ 850.7 $ 842.9 - 2.8%

Germany $ 1,429.8$ 1,435.3 $ 1,424.1 $ 1,418.10 $ 1,411.8 - 1.6%

Italy $ 2,143.9$ 2,157.0 $ 2,130.5 $ 2,116.7 $ 2,102.6 - 2.5%

Colombia $ 1,121.1$ 1,127.4 $ 1,114.1 $ 1,106.0 $ 1,096.1 - 2.8%

France $ 2,327.3$ 2,343.2 $ 2,311.4 $ 2,295.3 $ 2,279.2 - 2.7%

20152014 2016 2017 2018

$ 2,124.2

COUNTRYVARIATION2018/2014



The analysis of the graphs presented with the comparisons of stents and total primary knee prosthesis show that Brazil is included in the world average of sales to the final consumer.

30001500 2000 35001000500 2500 4000 4500

Source: DRG © 2019. Millennium Research Group, Inc. All rights reserved. Reproduction, distribution, transmission or publica-tion prohibited. Reprinted with permission. Chart prepared by ABRAIDI.

Average annual prices of primary total knee replacements paid by health care insurances or hospitals, in Latin American countries, in the United States, and in European countries, in US dollar, 2014 to 2018.In US$, from 2014 to 2018

SPAIN

UNITEDKINGDOM

ITALY

USA

ARGENTINA

BRAZIL

COLOMBIA

MEXICO

FRANCE

GERMANY

2014 20162015 2017 2018

0

GRAPH 26


PRICE COMPARISONS WITHIN COUNTRIES

Decisions to adopt the new technology, reim-bursement and procedure values are subject to a wide range of factors that do not involve purely the economic value of the product.

Implantable medical devices are products con-sidered “high risk” and require a high level of safety and efficacy evidence in the approval process for their incorporation.

There are more than twenty models of drug--eluting stents and only six of them have proved ef-fective in clinical trials.

Doctors are not very sensitive to price differen-ces and their preferences mainly reflect familiarity with certain brands, support, training, and inventory management in the case of hospitals.

In some countries, hospitals receive temporary additional payments for the use of new products.

The technological complexity, the number of manufacturers that operate in the market, the stage in the product life cycle, the differentiation of pro-ducts in the market and the possibility of incremen-tal innovations define the present price as well as its tendency to fall.

The fall in prices reflected the degree of ma-turity achieved in product technologies until a new disruptive technological wave occurs in the medical procedures related to the products under analysis.

FACTORS RELATEDTO THE PRODUCT ANDITS TECHNOLOGICALMATURITY STAGE

CONCLUSIONS

Prices for similar implants can vary signifi-cantly across regional markets.

These differences may arise from different types of bargaining, supply-demand conditions and bargaining power of hospitals or distribu-tors in these markets, as well as the range of unpaid services such as logistics, sterilization rate, disallowances, discounts, defaults and other market failures that end up being incor-porated into prices.

This fact was verified for several countries, according to a study by Wenzl and Mossialos (2018). The magnitude of the variation was quan-tified by the authors cited by calculating the coe-fficient of variation.

The study by Wenzl and Mossialos (2018) showed that price differentials are weakly corre-lated with hospital purchase volumes, but may relate to purchase volumes of a basket of pro-ducts of a particular manufacturer, modalities and time periods (WENZL and MOSSIALOS, 2018, p.1575).

PRICE COMPARISONS BETWEEN COUNTRIES

There was a trend of falling prices of the two products analyzed for the case of Brazil and the other countries considered in the analysis. The fall may be related to the technological ma-turity cycle of products abroad and in Brazil.

The prices of Brazilian products are com-patible with international parameters.

Despite the absence of trade barriers and harmonization of regulatory requirements among European countries, the price differen-ces of medical devices were significant among countries. As pointed out by Wenzl and Mos-sialos (2018), these differences suggest that fac-tors related to the internal structure of health systems determine these prices, such as: access to technology, rules for obtaining insurance reimbursements, purchase and compensation mechanisms hospitals and agents incentives to contain costs..

PRICETENDENCIES

The analysis of the graphs presented with the comparisons of stents and primary total knee prosthesis show that Brazil is included in the world average of sale to the final consumer. There is no severe discrepancy between prices in Europe and the United States compared to prices in Brazil. We have proved from this study that the media frenzy of many players over abusive values is not in line with reality. ABRAIDI shows again the reality of the market, perma-nently removing fantasies created, most of the time, with the intention of hiding what is really happening. The document produced here is a way of alerting society in general so that we stop analyzing isolated facts and concentrate on the whole. *

3. ANÁLISE COMPARATIVA DE PREÇOS DE DISPOSITIVOS MÉDICOS IMPLANTÁVEIS EM PAÍSES SELECIONADOS

4Distortions of the health system

4. DISTORTIONS OF THE HEALTH SYSTEM97THE CYCLE OF THE SUPPLY OF HEALTH PRODUCTS IN BRAZIL96

Last year, we showed a series of distortions that affect the entire Brazilian health system, es-pecially importers and distributors of health pro-ducts. In general, as mentioned, the imbalance in the relationship between the players leads to an unbalanced division of responsibilities that does not adequately remunerate each link in the heal-th chain and still burden the patient, either from the public system that has to spend more, or the private sector, which has to face abusive readjust-ments.

Distortions that affect distributors and impor-ters persist and, according to research with ABRAI-DI associates, have increased in volume and in-tensity, demonstrating that effective action is still needed to curb certain behaviors.

It is known that the Brazilian health system faces an unprecedented structu-ral crisis, with a huge imbalance in the relationship between the players in the sector, caused by poor regulation that does not control the abuses of economic power practiced by certain agents, besides conducts of commercial nature which contribute to high costs and low efficiency.

The imbalance in the responsibilities be-tween the players of the health system and the mechanisms of financial control adopted cause problems of remuneration of the links of the chain, burdening the patient.

The imbalance in the relationship between industry players caused by poor regulation contributes to high costs and low efficiency.

DISTORTIONSOF THE HEALTHSYSTEM

*

BILLINGRETENTION

The practice known as “billing retention” by insurers, health plans and hospitals occurs when, after performing the previously authorized surgi-cal procedure, and the consequent use of related products and materials, both the operator and the hospital do not authorize the billing, under pe-nalty of retaliation, thus postponing the payment of the materials.

According to ABRAIDI research with its as-sociates, the estimated total amount of billing withheld or blocked in 2018 reached R$488,5 million, against R$539,6 million in 2017, down 9.46%.

The average term until the issuance of the in-voice, after the surgery, in 2018 ranged from 29 to 53 days.

After the invoice was issued, the deadline for payment in 2018 ranged from 62 to 81 days.

In addition, it was possible to observe, in 2018, that there was an increase in retained billing amou-nts for private hospitals and for the SUS, in compa-rison with 2017. In relation to insurers and health plans, there was a reduction in the amounts.

994. DISTORTIONS OF THE HEALTH SYSTEM


20182017

Billing of ABRAIDI associatesretained by paying source.In R$ millions – 2017/2018

Source: Associates Research ABRAIDI

COVENANTS, HEALTH PLANS AND INSURERS

331

177113.8

148.9

PRIVATE HOSPITALS

94.8

162.6

SUS HOSPITALS

2018

Total: R$488,5 million1

1Calculation estimated based on the research sample associated with ABRAIDI.

GRAPH 27Average number of days untilthe issuance of ABRAIDI associates’invoices for each paying source.Comparative in days – 2017/2018



68

5362

45

PRIVATE HOSPITALS

54

29

SUS HOSPITALS

20182017

1Running days

GRAPH 28


Average number of days between invoiceissuance and payment - associatedwith ABRAIDI by paying source.Comparative in days – 2017/2018

92

62

83 81

91

67



PRIVATE HOSPITALS SUS HOSPITALS

20182017

GRAPH 29

Looking at the figure above, it is noted that a distributor takes, on average, around 112 days be-tween the supply of the products and the actual receipt of the payment. This equals 3 months and 22 days: 1 month and 12 days for the issuance of the invoice and 2 months and 10 days of the issue until payment.

In 2018, the survey with ABRAIDI associates revealed that, after the issuance of the invoice, 72.6% of the total amounts receivable from the companies are executed in the period between 30 and 90 days after the issuance of the invoice.

21,1% of retained earnings amounts are paid between 91 and 180 days, while 6.3% of the amounts take more than 180 days to be paid.

1 Average days spent between paying sources (estimate from the Associates Research ABRAIDI)

2 Average days spent between paying sources (estimate from the Associates Research ABRAIDI)

DAYS2

DAYS DAYSMONTHS112 223= +

70

BILLING AUTHORIZATIONSURGERY PAYMENT

Average time between invoice issuanceand receipt of ABRAIDI Associates.


DAYS1

42

APROVADO

AUTHORIZATION OF PROCEDURE

FIGURE 14


DISALLOWANCES

Generally, disallowances occur when the operator or health plan refuses to pay for some products, materials or equipment used in surgery previously authorized by them (in some cases, the entire hospital bill may be disallowed), for a series of bureaucratic reasons, third-party or non-justifiable.

In a survey carried out by ABRAIDI with its as-sociates in 2018, 87% of associates suffered from disallowances, which totals R$127,2 million in disallowed amounts, an increase of 26.2% compa-red to 2017.*

Total disallowances of ABRAIDI associates in 2018: R$127,2 million.

Occurrence of disallowance practiceby health plans or operators.In % of associates – 2018


GRAPH 30

Practice occurs

No practiceoccurs 13 %

%87


On average, 59% of disallowance cases are re-submitted by distributors, compared to 64% in 2017.

The recovery rate of the disallowance amou-nts in 2018 was 23%, against 22.7% in 2017.

The covenants, operators and health plans are responsible for 84% of all the volume of di-sallowances to be received by the distributors.

Total volume of disallowanceof ABRAIDI associates.In R$ millions – Comparative 2017/2018


100,8

127,2

Disallowance

20182017

GRAPH 31Another distortion that affects the entire health system is the default. It occurs when the pro-vider is not remunerated after 180 days from the completion of the surgical procedure. Also considered as default are amounts “lost” due to bankruptcy of the service provider or paying

Occurrence of losses with default by hospitals,operators and public agencies.In % of associates – 2018


Total estimate of losses, due to default, of ABRAIDI associates in 2018:

R$ 554.8 million.

source and even by intentional default.In 2018, 81% of ABRAIDI’s associates recorded los-ses with default by hospitals, operators or public agencies. In 2017, that index was 91%.*

Sufferlosses

Does notsuffer losses 19 %

%81

DEFAULT

GRAPH 32

4. DISTORTIONS OF THE HEALTH SYSTEM 4. DISTORTIONS OF THE HEALTH SYSTEM106 107THE CYCLE OF THE SUPPLY OF HEALTH PRODUCTS IN BRAZILTHE CYCLE OF THE SUPPLY OF HEALTH PRODUCTS IN BRAZIL

The hospital discount can be characterized as the unilateral practice of hospitals to require or impose on suppliers the concession of discou-nts as an essential condition for the supply of products, materials and equipment. In addition to the discount, it is possible to find cases in whi-ch hospitals charge the distributors the so-called “sterilization fee”, which is the hospital’s entire responsibility (see health surveillance standards) and is therefore already included in the account to the operators, thus not charging the supplier.

When suppliers refuse to give the discount, they are usually retaliated. In 2018, 67% of asso-ciates said they suffered retaliation, a 17% reduc-tion compared to 2017.

Occurrence of the hospital discount practice.In % of associates – 2018


Yes

No 27 %

%73

According to an ABRAIDI survey in 2018, 73% of the associates said that there is a hospital dis-count practice in their region of commercial ope-ration. In 2017, this number was 89%, which may indicate a possible reduction in the occurrence of this practice.

HOSPITALAR DISCOUNT

*

*

GRAPH 33

Occurrence of retaliation when denyingthe hospital discount concession.In % of associates – 2018


Yes

No 33 %

%67

After refusing to grant discounts, 43% of the associates were retaliated and stopped selling to the same client, while 57% of them were able to sell anyway.

GRÁFICO 34


or health plans, hospitals generally charge other fees, and may be called a “sterilization fee.” In 2018, 63% of the associates said they were pressured to pay these rates, compared to 60% in 2017.

The average time taken by an associate to re--sell his products to hospitals and health plans after refusing to grant discounts was 105 days in 2018, compared to 153 days in 2017.

Even when the sale is made directly to insurers

Percentage of ABRAIDI associateswho resold the customer, even afterrefusing to grant the discount.In % of associates – 2018


Did notresold

Resold 43%

%57

*

GRÁFICO 35

Occurrence of pressure by the hospitalfor the discount, even when the billingis done for the health plan.In % of associates – 2018


Yes

No 37 %

%63

GRAPH 36

4. DISTORTIONS OF THE HEALTH SYSTEM 4. DISTORTIONS OF THE HEALTH SYSTEM110 111THE CYCLE OF THE SUPPLY OF HEALTH PRODUCTS IN BRAZILTHE CYCLE OF THE SUPPLY OF HEALTH PRODUCTS IN BRAZIL

The most common unpaid services are the provision of equipment and instru-ments (75% of the associates) and the supply of surgical technologists perfusio-nists or other professionals (45.8% of the associates).

Suppliers are estimated to have billing losses equivalent to 7% of the value of the product with unpaid services.

Occurrence of unpaid servicesprovided by associates ABRAIDI.In % of associates – 2018


%75

%45.8

SUPP

LY O

F EQ

UIP

MEN

TA

ND

/OR

INST

RU

MEN

TS

SUR

GIC

AL

TEC

HN

OLO

GIS

TS/

PER

FUSI

ON

IST

S O

R

OT

HER

PR

OFE

SSIO

NA

LS

OT

HER

S

%20.8

Nowadays, in the health sector, providers are often faced with situations in which they are required to provide services that are not remunerated by hospitals, operators and health plans as a condition for selling products.

UNPAID SERVICES

*

GRAPH 37

LOSSES FOR DISTORTION


Additional costs to the distributor’s operation due to distortions in the health products sector.In % of average monthly operating cost

In 2018, the estimate of losses and costs caused to the operation of health care pro-viders reached 55%, against 42% in 2017. This shows the crisis faced by distributors and importers, who saw the distortions caused, hospitals, operators and health plans.

DEFAULT

VALIDITY LOSSES

BILLING RETENTION

LOSSES DUE TOPRODUCT WASTE OR

DAMAGE TO EQUIPMENTAND INSTRUMENTS

UNPAID SERVICES,SURGICAL TECHNOLOGISTS, EQUIPMENT,

INSTRUMENTS AND OTHERS

FINANCIAL DISCOUNTOR OTHER UNDUE FEES

DISALLOWANCES

4%

8%

12%

13%

7%

*

4%

7%

55%

DIS

TORT

ION

S

GRÁFICO 38

CONCLUSIONS


The companies that import and distribute health products face an unprecedented crisis, following the crisis that permeates the entire sec-tor, caused by the imbalance of responsibilities among health players.

Despite the apparent improvement over some distortions in the indus-try, there are still serious problems to be resolved.

The comparison of the average prices of some medical devices in Brazil and in other countries clearly shows that the Brazilian market is in line with the world market, making any governmental interference in the market unnecessary and harmful in terms of prices.

Government initiatives to improve the health system, improve access to and care for the population, and better regulate the interaction be-tween the actors of the system necessarily involve an open dialogue with all.

Currently, the health sector coexists with a tax complexity that brings negative impacts and costs for all companies. A tax reform is needed to organize the obligations and allow to increase the investments and the development of the sector.

It is fundamental, on the part of all, that the actions to raise the standards of ethics, conduct and integrity of the market should be placed as a priority.

When comparing the responses of the annual survey with ABRAIDI asso-ciates between 2017 and 2018, and considering the new information and data brought to the debate, it is possible to draw some conclusions.

*

BAIN J.S. (1959). Industrial Organization, New York, John Wiley & Sons, Inc. (II edition, 1967)

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114ABRAIDI ASSOCIATED COMPANIES - 2018


THE CYCLE OF THE SUPPLY OF HEALTH PRODUCTS IN BRAZILTHE CYCLE OF THE SUPPLY OF HEALTH PRODUCTS IN BRAZIL

ACREPSC DE HOLANDA

ALAGOASFIX BRASIL LTDA.IMPLAMEDICAL ALAGOAS COM. DE PRODUTOS MÉDICOS LTDA.

AMAZONASHW COMÉRCIO DE PRODUTOS HOSPITALARES LTDA. LIDERA COMÉRCIO DE ARTIGOS MÉDICOS LTDA-EPPRODRIGO SARAN AZEVEDO-ME

BAHIACORAMED COMÉRCIO DE ARTIGOS MÉDICOS LTDA.DUDER PRODUTOS MÉDICOS LTDA.HEMOCAT COMÉRCIO E IMPORTAÇÃO LTDA.IMPLANTES MÉDICOS BAHIA COM. DE PRODS. MÉD. HOSP. LTDA.JDR COMÉRCIO PRODUTOS CIRÚRGICOS LTDA.JOINTMED - COM. DE MAT. CIR. HOSP. E ORT. LTDA.MEDICICOR COMERCIAL - EIRELIORTHEK COMÉRCIO E IMPORTAÇÃO DE PRODUTOS HOSPITALARES LTDA.SYNTECH COMÉRCIO IMPORTAÇÃO EXPORTAÇÃO LTDA.

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Rio Branco

MaceióMaceió

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FortalezaFortalezaFortalezaFortalezaFortalezaFortalezaFortalezaFortaleza

BrasíliaBrasíliaBrasíliaBrasíliaBrasíliaBrasíliaBrasíliaBrasíliaBrasíliaBrasíliaBrasíliaBrasíliaBrasília

ABRAIDI ASSOCIATED COMPANIES

ESPÍRITO SANTO ALFA MEDICAL LTDABONE SURGERY COM. DIST. LTDA.COMERCIAL COSTA GOMES LTDA.EMILCARDIO PRODUTOS HOSPITALARES EIRELIENDOTEX COMERCIAL MATERIAIS MÉDICO HOSPITALARES LTDA.ENDOVIX IMP. E COM. DE MATERIAL HOSPITALAR LTDA.MEDICAL SUTURE COM. LTDA.MULTIVISION COMÉRCIO DE MATERIAL HOSP. EIRELIORTHOHEAD INSTR. E IMPL. CIRÚRGICOS LTDA.PH COMÉRCIO DE PRODUTOS HOSPITALARES LTDA.UL QUÍMICA E CIENTÍFICA LTDA.VITÓRIA HOSPITALAR LTDA.

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VitóriaVitóriaCariacicaVitóriaVitóriaVila VelhaVitóriaVitóriaSerraSerraVitóriaVitória

Aparecida de GoiâniaGoiânia

São LuísSão Luís

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PARÁ ART MED COMÉRCIO LTDA.-MEBIOSAÚDE PRODUTOS HOSPITALARES LTDA.CTA CLÍNICA TRAUMA ARLES EIRELI-EPPEXATA NORTE DISTR HOSPITALAR LTDA.IMPLANTUS COMÉRCIO E REPRES. DE PRODUTOS HOSPITALARES LTDA.

PARAÍBA ARTSÍNTESE COM. MAT. EQUIP. HOSPITALARES LTDA.CIENLABOR INDÚSTRIA E COMÉRCIO LTDA.PROMED MATERIAIS CIRÚRGIGOS LTDA.TOP IMPLANTES MATERIAIS CIRÚRGICOS LTDA.

PARANÁ ARTROFIX COMÉRCIO DE MATERIAIS CIRÚRGICOS LTDA.CARDIO E ENDO LUMINAL PROD MÉDICOS LTDA.CICLO MED DO BRASIL LTDA.FORMATHOS FORNECEDORA DE MATERIAL HOSPITALAR LTDA.HYPERDINÂMICA REPRESENTAÇÕES COMERCIAIS LTDA.INVASIVE IMP. E COM. DE PROD. MÉDICOS LTDA.L&G MATERIAIS CIRÚRGICOS LTDA.ONIVALDO BUENO MARQUES - EPPORTHOFACE IMPLANTES ESPECIAIS LTDA.ORTOESTE COM. PROD. MÉD. HOSPITALARES LTDA.POLYMEDICAL IMP. E COM. DE PRODUTOS MÉDICOS LTDA.PRÓ VASCULAR REPRESENTAÇÕES COMERCIAIS LTDA.PROSPINE COMÉRCIO DE MATERIAIS CIRÚRGICOS LTDA.PROSURG PRODUTOS MÉDICOS LTDA.PROTECNO COMÉRCIO DE MATERIAIS HOSPITALARES LTDA.TC TÉCNICA CIRÚRGICA COM. MAT. HOSP. ODONT. LTDA.TECMEDIC COMÉRCIO DE PRODUTOS MÉDICOS LTDA.TECNOMEDICAL PRODUTOS MÉDICOS LTDA.TKL IMP. E EXP. DE PRODUTOS MÉDICOS E HOSPITALARES LTDA.

PERNAMBUCO ADN SAÚDE COMÉRCIO DE PRODUTOS HOSPITALARES LTDA.BRASIL ORTOPEDIA COM. IMP. PROD. CIRURG HOSP. LTDA.GOLDMEDIC PRODUTOS MÉDICOS HOSPITALARES LTDA.JL MATERIAL CIRÚRGICO LTDA.NEUROFIX COM. DE MATERIAIS HOSPITALARES LTDA.-EPPORTHOMAC IMPLANTES E SOLUÇÕES MÉDICAS LTDA.ORTHOMAX MEDICAL COM. IMPL. ORTOP. LTDA.-EPPORTHOSERV COMÉRCIO E SERVIÇOS LTDA.-ME

Governador ValadaresGovernador ValadaresBelo Horizonte

AnanindeuaBelémParauapebasBelémBelém

João PessoaJoão PessoaJoão PessoaCampina Grande

LondrinaLondrinaCuritibaCuritibaCuritibaCuritibaCuritibaCuritibaCuritibaCuritibaCuritibaCuritibaCuritibaCuritibaCascavelCuritibaCuritibaCuritibaCuritiba

RecifeRecife RecifeRecifeRecifePetrolinaRecifeRecife

ORTOPLAN COMÉRCIO DE IMPLANTES ORTOPÉDICOS LTDA.PE IMPLANTES COM. IMPL. ORTOPÉDICOS LTDA.PROSMED PRODUTOS MÉDICOS LTDA.REPRESENTA MATERIAIS CIRÚRGICOS MÉDICOS E HOSPITALARES LTDA.

PIAUÍ BIOSÍNTESE COM. IMP. MAT. MÉD. HOSP. IMPL. LTDA.

RIO DE JANEIRO ARTERIAL LIFE SERVIÇOS E COMÉRCIO LTDA.AXISTE COMÉRCIO DE PRODUTOS MÉDICOS HOSPITALARES LTDA.BIOCARDIO COMÉRCIO E REPRESENTAÇÕES LTDA.CIBRAMED PRODS. MÉD. DESCART. COM. IMP. EXP. LTDA.CLASSY MED COMÉRCIO DE MATERIAL HOSPITALAR LTDA.-MECORTEX MED COM. DE PRODUTOS HOSP. LTDA.CROMO LIFE DIST. DE MATERIAIS HOSPITALARES LTDA.DMO DISTRIBUIDORA MATERIAIS ORTOPÉDICOS LTDA.E. TAMUSSINO & CIA. LTDA.ECMAX COMÉRCIO DE MATERIAL HOSPOSPITALAR LTDA.-MEENDO MEDICAL RIO COMERCIAL LTDA.ENDO SUTURE COMÉRCIO E REPRESENTAÇÕES LTDA.ENDOTEX COMERCIAL MAT. MÉD. HOSPTALARES LTDA.FLEX LAB COMÉRCIO DE MATERIAIS CIRÚRGICOS E HOSP. EIRELI-EPPINTER HOSPITALAR LTDA.LABORATÓRIOS B. BRAUN S/AMEDICAL HEALTH COMERCIO, SERVIÇOS E IMPORTAÇÃO EIRELINOVUM SALUTARIS HOSPITALAR LTDA.NUVASIVE BRASIL COMERCIAL LTDA.OPERANDI COMÉRCIO DE MATERIAL HOSPITALAR LTDA.ORTONENSE EQUIPAMENTOS HOSPITALARES LTDA.ORTONEURO COMÉRCIO E IMPORT. MATERIAIS HOSPITALARESPER PRIMA COMÉRCIO E REPRESENTAÇÕES LTDA.PORTO SURGICAL COMÉRCIO DE MATERIAL HOSPITALAR LTDA.REALCARE COM. E REPR. DE MAT. MÉDICO HOSP. LTDA.RIO SURGICAL COMÉRCIO DE MATERIAL HOSPITALAR LTDA.RPM COMÉRCIO DE MATERIAL HOSPITALAR LTDA.SINTEX MEDICAL IMPLANTES BIOMÉDICA COMERCIAL LTDA.TECHNICARE INSTRUMENTAL CIRÚRGICO LTDA.TECNEURO PRODUTOS CIENTÍFICOS E HOSPITALARES LTDA.TELLUS RIO COMÉRCIO IMP. EXP. LTDA.WM WORLD MEDICAL IMPORTAÇÃO E EXPORTAÇÃO LTDA.ZEIKI MEDICAL PRODUTOS MÉDICOS LTDA.

RIO GRANDE DO NORTE KOMPAZO SAÚDE DIST. DE PROD. E SERV. HOSPITALARES LTDA.LITORMED COMÉRCIO DE PRODUTOS MÉDICOS LTDA.ORBIMED COM. PROD. MÉDICOS LTDA.

Recife RecifeOlindaRecife

Teresina

Rio de JaneiroRio de JaneiroRio de JaneiroNiteróiRio de JaneiroRio de JaneiroRio de JaneiroRio de JaneiroRio de JaneiroRio de JaneiroRio de JaneiroItaperunaRio de JaneiroRio de JaneiroRio de JaneiroSão GonçaloRio de JaneiroRio de JaneiroRio de JaneiroNiteróiVolta RedondaRio de JaneiroRio de JaneiroRio de JaneiroRio de JaneiroRio das OstrasRio de JaneiroRio de JaneiroRio de JaneiroTrês RiosRio de JaneiroRio de JaneiroRio de Janeiro

NatalNatalNatal




RIO GRANDE DO SUL BOYNTON IMPORTAÇÃO E EXPORTAÇÃO LTDA.CANADÁ CENTRAL DE NEGÓCIOS DO BRASIL LTDA.DISCOMED COMÉRCIO PRODUTOS HOSPITALARES LTDA.ENDOSUL COM. E REP. DE MAT. CIRÚRGICO LTDA.GF MEDICAL IMPLANTES CIRÚRGICOS LTDA.IMPROTEC COMÉRCIO DE MATERIAL CIRÚRGICO LTDA.INMED COMÉRCIO DE MATERIAIS HOSPITALARES LTDA.INTELIMED COMÉRCIO E REPRESENTAÇÕES LTDA.JOMHEDICA NORTE PRODUTOS MÉDICOS HOSPITALARES LTDA.MODULUS EQUIPAMENTOS MÉDICOS LTDA.OSTHEON COMÉRCIO IMP. E EXP. DE PRODS. HOSPITALARES LTDA.PORTOMED COMÉRCIO E REP. DE MATERIAIS ORTOPÉDICOS LTDA.PROGER COMÉRCIO, IMPORTAÇÃO E EXPORTAÇÃO LTDA.PROSUL COM. E IMP. DE MATERIAIS MÉDICO-CIRÚRGICOS LTDA.PROTIL - PRÓTESE E INSTRUMENTAL LTDA.SERRA NORTE IMPLANTES ORTOPÉDICOS LTDA.ZAREK DISTRIBUIDORA DE MAT. CIRÚRG. E MEDICAMENTOS

SANTA CATARINA BR MEDICAL LTDA.CMO COMÉRCIO DE MATERIAIS ORTOPÉDICOS LTDA.FENERGY COM. PROD. MÉD. HOSP. LTDA.SELECTA MED DISTRIBUIDORA PRODUTOS MÉDICOS HOSPITALARES LTDA.

SÃO PAULO A2 MEDICAL SUPLLY COMÉRCIO E REPRESENTAÇÃO LTDA.-MEACERTTA DISTRIBUIDORA HOSPITALAR LTDA.ALLERGAN PRODUTOS FARMACÊUTICOS LTDA.-EPPANGIOMEDICAL COMÉRCIO DE PRODUTOS MÉDICOS LTDA.ARTHREX DO BRASIL IMP. COM. EQUIP. LTDA.ARTROMED DISTRIBUIDORABIOCATH COMÉRCIO DE PRODUTOS HOSPITALARES LTDA.BIOMAX MEDICAL COMÉRCIO E REPRESENTAÇÕES LTDA.BM9 - COM. DE MATERIAIS CIRÚRGICOS EIRELI-EPPBONE SURGICAL EQUIPAMENTOS MÉDICOS EIRELIBOSTON SCIENTIFIC DO BRASIL LTDA.BR HOMMED COM. MAT. MÉDICOS LTDA.BRAILE BIOMÉDICA INDÚSTRIA COMÉRCIO E REPRESENTAÇÕES LTDA.BRUNO GARISTO JUNIOR - BRUMED IMPLANTESCARDIOPIRA COM. IMPORT. MAT. HOSPITALARES LTDA.-EPPCARL ZEISS DO BRASIL LTDA.COMÉRCIO E IMPORTAÇÃO ERECTA LTDA.CORTEXMEDICAL COMERCIAL DE PRODUTOS MÉDICOS LTDA.CORTICAL COMÉRCIO DE PRODUTOS CIRÚRGICOS LTDA.CRUZ ALTA PRÓ HOSPITALAR EIRELIDABASONS IMPORTAÇÃO EXPORTAÇÃO E COMÉRCIO LTDA.

Porto AlegrePorto AlegrePorto AlegrePorto AlegrePorto AlegrePorto AlegrePorto AlegrePorto AlegrePorto AlegrePorto AlegrePorto AlegrePorto AlegrePorto AlegrePorto AlegrePorto AlegreCaxias do SulPorto Alegre

FlorianópolisSão JoséFlorianópolisGaruva

Mogi GuaçuSão PauloSão PauloCampinasSão PauloRio ClaroSão PauloSão PauloSão Caetano do SulSão PauloSão PauloItuSão José do Rio PretoSão José do Rio PretoPiracicabaSão PauloSão PauloSão PauloRibeirão PretoFernandópolisSão Paulo

DENUO MEDIC IMPORT. E EXP. LTDA.DMF MEDICAL MAT MÉDICOS LTDA. MEDPA DISTR. PAULISTA ARTIGOS MÉDICOSDPM VALE COM. DE PRODS. CIRÚRGICOS LTDA.-EPPEDWARDS LIFESCIENCES COM. PROD. MÉD. CIRÚRGICOS LTDA.ENDOTEC PRODUTOS MÉDICOS LTDA.FOCCUS MEDICAL EQUIPAMENTOS MÉDICOS EIRELIGADE IMP E EXP MAT EQUIPS HOSPS LTDA.GM DOS REIS JR. IND. E COM DE EQUIP. MÉDICOS LTDA.GUSSON - EQUIPAMENTOS MÉDICOS HOSPITALARES LTDA.HELCA IMP. EXP. COM. DE MAT. CIR. LTDA.HEXAGON IND. COM. DE IMPLANTES ORTOPÉDICOS LTDA.HMA PRODUTOS MÉDICOS LTDA.-MEHMS IMP. E COM. DE PROD. MÉDICOS LTDA.I 9 IMPLANTES, COM. DE PROD. E EQUIP. MÉD.HOSP. LTDA.I-MEDIC COMERCIO DE PRODUTOS HOSPITALARES LTDA-EPPIMPLAMED IMPLANTES ESP. COM.IMP. EXP. LTDA.INBONE COM. IMP. E EXP. DE PRODUTOS MÉDICOS LTDA.INOMEDICAL COM. PROD. HOSPITALARES LTDA.INOVASC DISTRIBUIDORA DE MATERIAL MÉDICO HOSPITALAR LTDA.-MEINTERMEDIC TECHNOLOGY IMPORTAÇÃO EXPORTAÇÃO LTDA.INVASIVE SP MEDICAL DEVICES COM. DE PRODS. MÉDICOS LTDA.IOL IMPLANTES LTDA.IOMED ORTOPEDIA ESPECIALIZADA LTDA.-EPPJOHNSON & JOHNSON DO BRASIL IND. E COM. PROD. SAÚDE LTDA.JOTEC DO BRASIL IMP E COM EQUIPS HOSPLAS - LATIM AMERICAN SOLUTIONS IMP. E EXP. LTDA.LDR BRASIL COM. IMP. EXP. PROD. MÉD. LTDA.LG COMERCIAL LTDA.LIMA DO BRASIL LTDA.LIVANOVA BRASIL COM. E DIST. DE EQUIP. MÉD. HOSP. LTDA.LIVE COM. DE PROD. CIRÚRGICOS MÉD. HOSP.LTDA.LOTTUS COM. IMP. E EXP. DE MATERIAIS MÉDICOS LTDA.M&LIMA COM MAT MÉD LTDA.-MEMAX CARE IMPORT. E DIST. DE PRODS. MÉDICOS HOSP. LTDA.-EPPMAX SURGICAL COMÉRCIO DE IMPLANTES ORTOPÉDICOS LTDA.MAXI MÉDICA ARTIGOS CIRÚRGICOS E HOSPITALARES LTDA.MB OSTEOS - COM. IMP. MATERIAL MÉDICO LTDA.MEDARTIS IMPORTAÇÃO E EXPORTAÇÃO LTDA.MEDCORP HOSPITALAR LTDA.MEDIC CALL COM. DE PRODTS. MÉDICO HOSPITALARES LTDA.MEDIC SOLUTION PROD.MÉD. HOSPITALARES LTDA.MEDICAL ORTOPEDIA COM. IMP. EXP. MAT. CIRÚR. LTDA.MEDICAL PROVIDER COM. ATACADISTA DE MATS. MÉD. E HOSP. LTDA.MEDICAL SUPORT MAT. MÉD. HOSPITALARES LTDA.-MEMEDTRONIC COMERCIAL LTDA.MF MEDICAL COM. DE PRODTS. MÉDICOS E HOSPITALARES LTDA.-EPP

São PauloSanto AndréSão PauloSão José dos CamposSão PauloSão PauloSão PauloSão Bernardo do CampoCampinasFernandópolisSão PauloItapiraSão Caetano do SulS. Bernardo do CampoSão PauloValinhosSão PauloSão PauloSão PauloSão José dos CamposSão PauloSão PauloDiademaSão PauloSão PauloValinhosSão PauloSanto AndréBonfim PaulistaBarueriSão PauloSão PauloCampinasSão PauloSão PauloRio ClaroSão PauloSão PauloSão PauloSão PauloSão Bernardo do CampoSão PauloValinhosCampinasRibeirão PretoSão PauloSão Paulo




MICROMEDICAL IMPLANTES DO BRASIL LTDA.MM MEDICAL PRODUTOS MÉDICOS E HOSPITALARES LTDA.MP COMÉRCIO DE PRODUTOS MÉDICOS LTDA.MR ORTHOS COM. E IMP. DE PROD. HOSP. LTDA.-EPPNIVAA PRODUTOS MÉDICOS E HOSPITALARES LTDA.NOVELTY COM. IMP. PROD. CIRÚRG. ORTOP. LTDA.-EPPOP ASSIS – MEORTHO STEEL DISTRIBUIDORA DE MATERIAL HOSP. LTDA.ORTHO SYSTEM-COM. IMPORT. E EXPORT. DE IMPLANT. ORTOP. LTDA.ORTHOFIX DO BRASIL LTDA.ORTHOMAXX HOSPITALAR EIRELIORTHONEURO COM. IMP. EXP. PRODS. MÉDICOS LTDA.ORTO´S COM. PROD. MED. HOSP. LTDA.ORTOCIR ORTOPEDIA CIRÚRGIA LTDA.ORTOMEDIC DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA.ORTOMED-PRÓ HOSPITALAR COM. E REPR. LTDA.ORTOSPINE COM. IMP. E EXP. DE MAT. HOSP. LTDA.ORTOSYS COMÉRCIO DE MATERIAIS CIRÚRGICOS LTDA.OSTEOLINK PRODUTOS MÉDICOS LTDA.OSTEUM PRODUTOS MÉDICOS E HOSPITALARES LTDA.-MEPAOLA PORTALEONI EIRELI-EPPPRIME CIR. IMP. EXP. COM. DE PROD. ORT. LTDA.-EPPPRISMA MEDICAL LTDA.PRONEC EQUIPAMENTOS CIRÚRGICOS LTDA.-MEQUANTUM IMPORTAÇÃO E DISTRIB. DE PRODUTOS MÉDICOS LTDA.RCL IMP. COM. LOC. MAT. MED. HOSPITALARES LTDA.RIAADE SUPRIMENTOS MÉDICOS LTDA.ROVER DISTRIBUIDORA DE PRODS. PARA SAÚDE LTDA.SAO PAULO SURGICAL COMÉRCIO DE MATERIAL HOSPITALAR LTDA.SINNERGY IMPORTAÇÃO E EXPORTAÇÃO LTDA.SLIM PRODUTOS MÉDICOS EIRELI-MESMITH & NEPHEW COM. DE PRODS. MÉDICOS LTDA.SOMMA PRODUTOS HOSPITALARES LTDA.SP INTERVENTION LTDA.SPINE LEVEL - COM. IMPORT. E LOCAÇÃO DE PRODS. MÉDICOS LTDA.SPM COMÉRCIO DE PRODUTOS MÉDICOS LTDA.STRYKER DO BRASIL LTDA.SUPPORT SURGICAL COM. DE PROD. HOSP. E ODONT. EIRELI - EPPSURGICARE COM. PROD. CIRÚRGICOS LTDA.SYNCROFILM DISTRIBUIDORA LTDA.TECHNICARE SOCORRO TÉCNICO MAT. HOSP. LTDA.TECNIMED COM. IMP. DE PROD. MÉD. HOSP.LTDA.TELLUS COMÉRCIO IMPORTAÇÃO E EXPORTAÇÃO LTDA.TRAUMACAMP COM. E LOCAÇÃO DE PROD. MÉD. HOSP. LTDA.TRÍADE IMPLANTES COM. IMP. EXP. IMPL. ORT. LTDA.VENTURA BIOMÉDICA LTDA.WL GORE & ASSOCIATES DO BRASIL LTDA.

São PauloSão PauloSão PauloSão PauloCampinasS. Bernardo do CampoSão Caetano do SulSta. Cruz do Rio PardoValinhosRio ClaroSão PauloSão José do Rio PretoSão PauloSão PauloSão PauloS. Bernardo do CampoSorocabaBarueriCampinasS. Bernardo do CampoSão Caetano do SulPraia GrandeCampinasRibeirão PretoRibeirão PretoCotiaSão Caetano do SulRibeirão PretoS. Bernardo do CampoSão PauloSão PauloSão VicenteSão PauloRibeirão PretoSão PauloS. Bernardo do CampoS. Bernardo do CampoSão PauloCampinasPaulíniaSão PauloSão PauloSão Caetano do SulSão PauloCampinasSão José dos CamposSão José do Rio Preto

WORLD MEDICA COMERCIO DE PRODUTOS MEDICOS LTDA.WRIGHT MEDICAL LTDA.X-SAFE COM. PROD. MED. HOSP. LTDA.

SERGIPE IMPLAMEDICAL SERGIPE COMÉRCIO DE PRODUTOS MÉDICOS LTDA.MEDPLACE DISTR MEDICO HOSPITALAR LTDA.-MEORTOPLAN SERGIPE LTDA.

São PauloSão PauloSão Caetano do Sul

AracajuAracajuAracaju


ABRAIDIBrazilian Association of Importers and

Distributors of Health Products

Rua General Jardim, 770 - 1º andar - conjunto 1AVila Buarque - São Paulo - SP

4 the cycle of the supply of health products in brazil · 2021. 4. 5. · operation of import and...

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