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Brazil’s population has topped 200 million and ist still growing. Latin America’s largest

market for pharmaceuticals is also first on the list of emerging target markets for German

makers of patented drugs and generics. PharmaReport Brazil provides German companies

with regular, relevant legislative and regulatory news.

It is a service of the initiative Health – Made in Germany, whose aim is to strengthen Gemany's

position as a leading global provider of health care products and services. Health – Made in Germany

was initiated by Germany's Ministry for Economic Affairs and Energy (BMWi).

Regarding legislative news, a law to speed up the drug registration process and a law for traceability of the

drugs during the entire process was sanctioned. Additionally, the House of Representatives approved a bill

banning the interruption of drug production without the government‘s authorization and debated over the

patent law, to reduce drug prices for HIV/AIDS treatment. Further, Representatives approved a bill that

relieves pensioners from the duty to pay federal taxes on prescription medication prescribed by a public

health system professional. The government introduced to Congress an Act that gives permission to reduce

drug prices in exceptional cases and the House of Representatives is also analyzing a bill that determines a

tax exemption for dengue vaccinations.

ANVISA published several resolutions, including a resolution that introduces changes concerning the

inclusion, modification and exclusion of items into the list of Common Brazilian Terms for pharmaceuticals.

Another resolution adds products to the original list of products frequently imported by patients with

corresponding medical prescriptions. ANVISA introduced an update of the list of narcotics, psychotropic

drugs and other drugs under special control and allowed pharmaceutical ingredients listed in Normative

Instruction n° 3 to be manufactured, imported and commercialized. An additional resolution introduced

control measures for the sale, prescription and distribution of drugs containing anfepramone,

femproporex, mazindol and sibutramine. Further regulation proposed drug traceability anticipating the

changes that are awaiting presidential approval. ANVISA has also issued explanatory information about

codes for pre-consultation regarding the possibility of dosage biowaiver or due to pharmaceutical form.

The deadline for filling petitions of innovative drugs for complexity evaluation has been postponed and

ANVISA reopened the discussion regarding the outsourcing of stages of productions, quality control and

drug storage.

On drug pricing, as a consequence of the economic crisis, pharmaceutical industry has granted significant

sales discounts to the public sector. Drugs for the treatment of Recurrent-Remitting Multiple Sclerosis,

non-small cell lung cancer, overweight and obesity and renal cancer were approved by ANVISA. The Public

Health System has also two new drugs available for treatment of secondary hyperparathyroidism.

According to Interfarma sales in drugstores have grown by 42% in five years. The Febrafar Institute of

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Research and Continued Education released a study that shows that 45% of customers are prioritizing price

(on generic drugs) to the detriment of the brand when buying drugs.

ANVISA signed an agreement together with the Pan American Health Organization for the implementation

of Regulatory Exchange Platform Secured in the Agency. The Ministry of Health will invest on technology

transfer and acquisition for production of a growth hormone and drugs for rheumatoid arthritis and

oncologic diseases. The Federal Pharmacy Council elaborated a technical note to proceed with the Sectoral

Agreement regarding reverse logistics of drugs. Also, the Brazilian postal service will distribute drugs for the

Public Health System.

Legislation

1. Law 13.410/2016 and law 13.411/2016 were sanctioned by the Brazilian President

29/12/2016 Two new laws on drug registration and control were published in the Federal Official Gazette. Law 13.411/2016 speeds up the drug registration process. Drugs registered as “urgent” need to be registered within 90 days, other drugs have now 120 days or more (max. 365 days for so-called “general” drugs) for registration before they are allowed to be sold on the Brazilian market. Law no. 13.410/2016 changes the rules for the application of the National Drug Control System. It now permits the tracking of drugs from their production until they reach the final consumer. For more information on the provisions of these new laws, please see the articles within our October and November newsletters. The laws will enter into force 90 days after their publication. Links: http://www12.senado.leg.br/noticias/noticias/materias/2016/12/29/sancionadas-duas-leis-para-registro-e-controle-de-remedios-no-pais http://www.planalto.gov.br/CCIVIL_03/_Ato2015-2018/2016/Lei/L13410.htm http://www.planalto.gov.br/CCIVIL_03/_Ato2015-2018/2016/Lei/L13411.htm 2. House of Representatives’ Bill (Projeto de Lei da Câmara dos Deputados – PL) 1135/15

05/12/2016 The House of Representatives’ Committee for Social Security and Family Affairs approved a bill banning the interruption of drug production without the government‘s authorization, referring to drugs for continuous use that do not have a similar or generic equivalent on the market. According to the bill, pharmaceutical companies will have to report any intention of taking the above-mentioned drugs temporarily or definitely

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off the market twelve months in advance. The bill stipulates further that the companies would have to inform the reasons for taking the drugs off the market as well as a time line for continuing production. The bill is now going to be analyzed by the Committee for Constitutional, Justice and Citizenship Affairs. Link: http://www2.camara.leg.br/camaranoticias/noticias/SAUDE/520689-SEGURIDADE-PROIBE-INTERRUPCAO-DE-PRODUCAO-DE-REMEDIO-SEM-AVAL-DO-GOVERNO.html 3. Debates in the House of Representatives request revision of the patent law and integration of new drugs

for HIV/AIDS treatment

05/12/2016 The revision of the trademark and patent law (law no. 9.279/96) to reduce drug prices was debated this Monday during a joint session of the Human Rights Commission and the Participative Legislation Commission in the House of Representatives. Both commissions debated as well the integration of new drugs for HIV/AIDS treatment in Brazil. During the debate the twenty-year protection of patents, breaking of patents, compulsory licenses and other measures such as international cooperation were discussed as possible options to provide drugs at a lower price for patients with HIV, cancer and Hepatitis C. Links: http://www2.camara.leg.br/camaranoticias/noticias/SAUDE/520727-DEBATEDORES-PEDEM-REVISAO-DA-LEI-DE-PATENTES-PARA-REDUZIR-PRECO-DE-REMEDIOS.html http://www2.camara.leg.br/camaranoticias/noticias/SAUDE/520656-INCORPORACAO-DE-NOVOS-MEDICAMENTOS-PARA-TRATAR-HIVAIDS-E-TEMA-DE-DEBATE.html 4. House of Representatives’ Bill (Projeto de Lei da Câmara dos Deputados – PL) 5178/16

09/12/2016 The Senior Citizens Rights Committee approved bill no. 5178/16, which relieves pensioners within the so-called Regime Geral de Previdência Social from the duty to pay federal taxes on prescription medication prescribed by a public health system professional. This initiative works towards a reduction of consumer prices for drugs. Especially within this demographic group the cost is considered considerably higher due to elevated necessities of health treatments. The bill will now be discussed conclusively by the Finance and Tax Committee and the Committee for Constitutional, Justice and Citizenship Affairs. Link: http://www2.camara.leg.br/camaranoticias/noticias/SAUDE/521048-COMISSAO-ASSEGURA-A-APOSENTADO-ISENCAO-DE-TRIBUTOS-EM-MEDICAMENTOS.html

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5. Federal Provisional Act 754/2016

20/12/2016

The government introduced to Congress the Provisional Act (Medida Provisória) 754/16, which gives permission to the Chamber of Regulation of the Drug Market (CMED) Council to authorize the reduction of drug prices in exceptional cases. Please see also our article on this topic in our November newsletter. Bill no. 10.742/03 which created the CMED already included rules to regulate the pharmaceutical sector, but authorized only a one time per year drug price reduction. The Provisional Act now changes the bill, extending the possibilities of drug price reductions, without altering the possibility to increase drug prices in exceptional cases, which had been already a part of the bill no. 10.742/03. The MP is being questioned by several representatives, who are fearing that it will be used to increase drug prices continuously, and that it only beneficiates the pharmaceutical industry, since CMED consists of industrial and commercial representatives only. In order to stay valid, the MP has to be approved by both the House of Representatives and the Senate and converted into law according to the provisions of the Federal Constitution of Brazil. Links: http://www2.camara.leg.br/camaranoticias/noticias/SAUDE/521607-MP-AUTORIZA-REDUCAO-OU-AUMENTO-DE-PRECO-DE-REMEDIO-A-QUALQUER-TEMPO.html http://www2.camara.leg.br/camaranoticias/radio/materias/RADIOAGENCIA/521815-DEPUTADOS-QUESTIONAM-MEDIDA-PROVISORIA-QUE-PERMITE-MUDANCA-NOS-PRECOS-DE-REMEDIOS.html http://www2.camara.leg.br/camaranoticias/noticias/SAUDE/521816-MP-QUE-AUTORIZA-REAJUSTE-DE-MEDICAMENTOS-E-ALVO-DE-CRITICAS.html 6. House of Representatives debates tax reliefs for dengue vaccination

22/12/2016 The House of Representatives is currently analyzing bill no. 5908/16, which determines a tax exemption for dengue vaccinations from import tax (Imposto de Importação - II) and from the federal tax on processed products (Imposto sobre Produtos Industrializados - IPI). Link: http://www2.camara.leg.br/camaranoticias/noticias/SAUDE/521647-PROPOSTA-ISENTA-DE-TRIBUTOS-VACINA-CONTRA-DENGUE.html

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Regulatory Affairs – ANVISA 1. ANVISA Resolution RDC n°. 127

Resolution

01/12/2016

Published on December 2nd, 2016, in Official Federal Gazette (DOU) No. 231, Section 1, page 63

This resolution introduces changes to resolutions RDC nº 64/2012 and nº 104/2016, concerning the inclusion, modification and exclusion of items into the list of Common Brazilian Terms for pharmaceuticals – DCB (Denominações Comuns Brasileiras). The updated DCB list includes nine new active pharmaceutical substances, as well as ten new excipients and four new biological products. Links: http://portal.anvisa.gov.br/noticias?p_p_id=101_INSTANCE_FXrpx9qY7FbU&_101_INSTANCE_FXrpx9qY7FbU_groupId=219201&_101_INSTANCE_FXrpx9qY7FbU_urlTitle=insumos-farmaceuticos-e-31-novos-itens-sao-incluidos-na-dcb&_101_INSTANCE_FXrpx9qY7FbU_struts_action=%2Fasset_publisher%2Fview_content&_101_INSTANCE_FXrpx9qY7FbU_assetEntryId=3113716&_101_INSTANCE_FXrpx9qY7FbU_type=content http://portal.anvisa.gov.br/legislacao#/visualizar/334663 http://portal.anvisa.gov.br/documents/10181/2718376/RDC_127_2016_.pdf/c16e3b6c-bb53-4106-9be1-c467b6c74941 2. ANVISA Resolution RDC n°. 128

Resolution

02/12/2016

Published on December 2nd, 2016, in Official Federal Gazette (DOU) No. 232, Section 1, page 33

The resolution introduces an update of Annex 1 (cannabidiol based products and products associated with other cannabinoids, inter alia THC) in accordance with chapter 1, section II of resolution RDC n° 17, from the 6th of May 2015. The update adds products to the original list of products frequently imported by patients with corresponding medical prescriptions. Import proceedings for these patients are simplified. A list of added drugs can be found at the links below. None of these cannabidiol based products are registered in Brazil or have been submitted to clinical tests with ANVISA. However, they had already received import authorization by ANVISA. Links: http://portal.anvisa.gov.br/legislacao#/visualizar/334664

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http://portal.anvisa.gov.br/noticias?p_p_id=101_INSTANCE_FXrpx9qY7FbU&_101_INSTANCE_FXrpx9qY7FbU_groupId=219201&_101_INSTANCE_FXrpx9qY7FbU_urlTitle=atualizada-lista-de-produtos-com-canabidiol-importados&_101_INSTANCE_FXrpx9qY7FbU_struts_action=%2Fasset_publisher%2Fview_content&_101_INSTANCE_FXrpx9qY7FbU_assetEntryId=3112819&_101_INSTANCE_FXrpx9qY7FbU_type=content 3. ANVISA Resolution RDC n°. 130

Resolution

02/12/2016

Published on December 4th, 2016, in Official Federal Gazette (DOU) No. 232, Section 1, page 33

The resolution introduces an update of Annex 1 (list of narcotics, psychotropic drugs and other drugs under special control) of decree SVS/MS nº 344, from May 12, 1998. The decree was updated in view of the final phase of registration proceedings for the drug Mevatyl® in Europe and the possibility of future prescription in Brazil. As of now, there are no drugs based on the plant Cannabis sativa L. available in the country. ANVISA alerts furthermore that Mevatyl® stands in no relation with cannabidiol based drugs imported exceptionally by certain patients (see our article above on RDC 128). Links: http://portal.anvisa.gov.br/legislacao#/visualizar/334666 http://portal.anvisa.gov.br/noticias?p_p_id=101_INSTANCE_FXrpx9qY7FbU&_101_INSTANCE_FXrpx9qY7FbU_groupId=219201&_101_INSTANCE_FXrpx9qY7FbU_urlTitle=nova-regra-permite-medicamento-com-canabidiol-e-thc&_101_INSTANCE_FXrpx9qY7FbU_struts_action=%2Fasset_publisher%2Fview_content&_101_INSTANCE_FXrpx9qY7FbU_assetEntryId=3112766&_101_INSTANCE_FXrpx9qY7FbU_type=content 4. ANVISA Normative Instruction – IN n°. 14

09/12/2016

Published on December 12th, 2016, in Official Federal Gazette (DOU) No. 238, Section 1, page 44

This Normative Instruction determines that pharmaceutical ingredients listed in Normative Instruction n° 3 from June 2013 may be manufactured, imported and commercialized if the registration had been granted or registration request had been filed with all necessary documentation requested by RDC n° 57/2009. Links: http://portal.anvisa.gov.br/legislacao#/visualizar/337082 http://portal.anvisa.gov.br/documents/10181/3132266/IN_14_2016_.pdf/21cd69f9-d078-4675-8337-7c3f0a2ba059

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5. ANVISA Resolution RDC no. 133

Resolution

15/12/2016

Published on December 13th, 2016, in Official Federal Gazette (DOU) No. 241, Section 1, page 201

The resolution modifies resolution RDC nº 50, issued on September 25th, 2014, which introduces control measures for the sale, prescription and distribution of drugs containing anfepramone, femproporex, mazindol and sibutramine, its salts and isomers. Drugs based on formulas containing anfepramone, femproporex and mazindol continue to be prohibited – except for formulas present in registered drugs with proven efficacy - since art. 9 of RDC nº 50 was not modified. Since there are currently no registered drugs based on these substances in Brazil, those drugs may not be commercialized in the country. The resolution also stipulates limits for the daily dosages (DDR) recommended for these drugs. Links: http://portal.anvisa.gov.br/legislacao#/visualizar/337083 http://portal.anvisa.gov.br/documents/10181/3136242/RDC_133_2016_.pdf/4f8401f3-b081-4b3e-ad38-bbf37d44f16f http://portal.anvisa.gov.br/noticias?p_p_id=101_INSTANCE_FXrpx9qY7FbU&_101_INSTANCE_FXrpx9qY7FbU_groupId=219201&_101_INSTANCE_FXrpx9qY7FbU_urlTitle=rdc-reune-regras-para-venda-dos-anorexigenos&_101_INSTANCE_FXrpx9qY7FbU_struts_action=%2Fasset_publisher%2Fview_content&_101_INSTANCE_FXrpx9qY7FbU_assetEntryId=3137431&_101_INSTANCE_FXrpx9qY7FbU_type=content 6. Regulation proposal: traceability is discussed in public audience

07/12/2016 The ANVISA regulation proposal on drug traceability anticipates the changes that are due to bill (PL) no. 4069/2015, which already passed the House of Representatives and is now awaiting presidential approval. The proposal includes a variety of important points already included in the bill, as for example a centralized data base, coordinated by the agency and the assessment that some drugs do not need to be traced, as for example nonprescription drugs and products acquired through Health Ministry programs, because these already went through a particular program of acquisition, which monitors every step. Link: http://portal.anvisa.gov.br/noticias?p_p_id=101_INSTANCE_FXrpx9qY7FbU&_101_INSTANCE_FXrpx9qY7FbU_groupId=219201&_101_INSTANCE_FXrpx9qY7FbU_urlTitle=rastreabilidade-e-discutida-em-audiencia-publica&_101_INSTANCE_FXrpx9qY7FbU_struts_action=%2Fasset_publisher%2Fview_content&_101_INSTANCE_FXrpx9qY7FbU_assetEntryId=3117589&_101_INSTANCE_FXrpx9qY7FbU_type=content

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7. Explanation of the codes for pre-consultation in dosage biowaiver or pharmaceutical form biowaiver

05/12/2016

ANVISA has issued explanatory information about codes for pre-consultation regarding the possibility of dosage biowaiver or due to pharmaceutical form issued by the Chamber of Regulation of the Drug Market (CMED): 10927 – Proportionality of the formulations for biowaiver of other dosages 10928 – Biowaiver due to pharmaceutical form These codes may only be used for consultation prior to the submission of the application for registration of generic, similar and new drugs. In case of use of these codes for consultation regarding biowaiver of drugs whose application for registration has already submitted, or are already registered or whose analysis is the responsibility of another management area, the request will be closed. Link:

http://portal.anvisa.gov.br/noticias?p_p_id=101_INSTANCE_FXrpx9qY7FbU&_101_INSTANCE_FXrpx9qY7F

bU_groupId=33836&_101_INSTANCE_FXrpx9qY7FbU_urlTitle=esclarecimento-acerca-dos-codigos-de-

assunto-para-consulta-previa-sobre-

bioisencao&_101_INSTANCE_FXrpx9qY7FbU_struts_action=%2Fasset_publisher%2Fview_content&_101_I

NSTANCE_FXrpx9qY7FbU_assetEntryId=3113395&_101_INSTANCE_FXrpx9qY7FbU_type=content

8. Deadline for petitioning of innovative medicines postponed

14/12/2016

The Chamber of Regulation of the Drug Market (CMED) informed that the deadline for filling petitions of innovative drugs for complexity evaluation has been postponed until January 31, 2017. The postponing is motivated by a series of questions presented about completing the form. ANVISA will monitor the petitions of innovative drug that await in the line for the registry analysis, to accelerate the process. Link: http://portal.anvisa.gov.br/noticias?p_p_id=101_INSTANCE_FXrpx9qY7FbU&_101_INSTANCE_FXrpx9qY7F

bU_groupId=219201&_101_INSTANCE_FXrpx9qY7FbU_urlTitle=prorrogado-prazo-de-peticoes-de-

medicamento-

inovadores&_101_INSTANCE_FXrpx9qY7FbU_struts_action=%2Fasset_publisher%2Fview_content&_101_I

NSTANCE_FXrpx9qY7FbU_assetEntryId=3133219&_101_INSTANCE_FXrpx9qY7FbU_type=content

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9. ANVISA answers questions regarding installations outsource proposal

12/12/2016

As mentioned in the Newsletter edition of November, ANVISA reopened the discussion regarding the outsourcing of stages of productions, quality control and drug storage. On December 8, 2016, ANVISA organized a meeting to clarify the Public Consultation Nr. 273 on this topic. It was organized together with Abimip (Brazilian Non-Prescription Medicine Industry Association), Alanac (National Pharmaceutical Labs Association), FarmaBrasil Group (Association for representation of Aché, Biolab, Cristália, Libbs, EMS, Hypermarcas, Hebron, Eurofarma and União Química), Interfarma (Association of the Research Driven Pharmaceutical Industries), PróGenéricos (Generic Drugs Association) and Sindusfarma (Pharmaceutical Industry Union). ANVISA discussed questions regarding the RDC n. 61 (published on February, 3, 2016) but also stated that the agency is open to evaluate each case as well as possible exceptions to the rule. Link: http://sindusfarma.org.br/cadastro/index.php/site/ap_noticias/noticia/1464

Drug pricing

1. Reduction of sales prices for drugs sold to public sector due to economic crisis

12/12/2016

As a consequence of the economic crisis, pharmaceutical industry have granted significant sales discounts to the public sector due to negotiations by the public sector. At the federal level, reductions were, on average, 7% for synthetic drugs bought in Brazilian currency Reais and 17% for those negotiated in US-Dollar. For instance, at the end of September an agreement with GSK (GlaxoSmithKline) was announced according to which HIV drugs were bought at a discount of 70%. In 2016, sales to the public sector represented half of that company´s revenue. But according to the Association of the Pharmaceutical Research Industry, Interfarma, tough negotiations are a lesser problem than the decreasing purchase volume of the public entities which in consequence lead to shortages as well as payment defaults. Link: http://www.interfarma.org.br/noticias/1151

Drug licensing and registration

1. Product approved for the treatment of Multiple Sclerosis

27/12/2016

The new biological product Plegridy (peginterferona beta-1a), used in the treatment of Recurrent-Remitting Multiple Sclerosis (RRMS) in adult patients, has been registered and approved by ANVISA.

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The active substance in Plegridy® is peginterferona beta-1a which may prevent the body´s defense system from damaging the brain and the spinal cord. Peginterferona beta-1a is a long-term modifier form of interferon, a natural substance produced by the body and responsible for protecting against infections and diseases. Although it does not cure the disease, the treatment with Plegridy® can delay the disabling effects of MS and can help in reducing the outbreaks.

Link:

http://portal.anvisa.gov.br/noticias?p_p_id=101_INSTANCE_FXrpx9qY7FbU&p_p_col_id=column-

2&p_p_col_pos=1&p_p_col_count=2&_101_INSTANCE_FXrpx9qY7FbU_groupId=219201&_101_INSTANCE

_FXrpx9qY7FbU_urlTitle=aprovado-produto-para-tratamento-de-esclerose-

multipla&_101_INSTANCE_FXrpx9qY7FbU_struts_action=%2Fasset_publisher%2Fview_content&_101_INS

TANCE_FXrpx9qY7FbU_assetEntryId=3162315&_101_INSTANCE_FXrpx9qY7FbU_type=content

2. ANVISA approves new drug for treatment of lung cancer

19/12/2016

ANVISA approved a new drug to treat non-small cell lung cancer (NSCLC). The drug is included in the category “new drugs“, which applies to innovative products with synthetic and semi-synthetic active ingredients. ANVISA approved the registration of the new drug Tagrisso® (orsimertinib), in the pharmaceutical form of a coated pill. It is indicated for the treatment of patients of non-small cell lung cancer (NSCLC) with locally advanced or metastatic, MTCT-positive, which progresses using, or after a therapy with inhibitors of the tyrosine kinase to the epidermal growth factor receptors (EGFR TKI) Lung cancer is an aggressive, heterogeneous, and life-threatening disease. It has been one of the most common cancers in the world for several decades. Link:

http://portal.anvisa.gov.br/noticias?p_p_id=101_INSTANCE_FXrpx9qY7FbU&_101_INSTANCE_FXrpx9qY7F

bU_groupId=219201&_101_INSTANCE_FXrpx9qY7FbU_urlTitle=anvisa-registra-novos-

medicamentos&_101_INSTANCE_FXrpx9qY7FbU_struts_action=%2Fasset_publisher%2Fview_content&_10

1_INSTANCE_FXrpx9qY7FbU_assetEntryId=3143730&_101_INSTANCE_FXrpx9qY7FbU_type=content

3. ANVISA approves new drug for treatment of obesity

19/12/2016

ANVISA further approved an additional new drug in the category “new drugs“, which applies to innovative products with synthetic and semi-synthetic active ingredients. The drug, approved by ANVISA was Belviq® (lorcaserin hydrochloride hemihydrate), also in the pharmaceutical form of a coated pill. It is a drug indicated as an aid to a calorie reduction diet and

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increased physical activity for chronic weight control in adult patients with an initial BMI of 30kg/m² or more (obese); or overweight patients with a BMI greater than or equal to 27kg/m², in the presence of at least one weight-related disease, such as hypertension, dyslipidemia, cardiovascular disease, type 2 diabetes controlled with oral hypoglycemic agents, or sleep apnea. Obesity is one of the most prevalent chronic diseases worldwide. It is considered a multiple cause disorder and is associated with several diseases.

Link:

http://portal.anvisa.gov.br/noticias?p_p_id=101_INSTANCE_FXrpx9qY7FbU&_101_INSTANCE_FXrpx9qY7F

bU_groupId=219201&_101_INSTANCE_FXrpx9qY7FbU_urlTitle=anvisa-registra-novos-

medicamentos&_101_INSTANCE_FXrpx9qY7FbU_struts_action=%2Fasset_publisher%2Fview_content&_10

1_INSTANCE_FXrpx9qY7FbU_assetEntryId=3143730&_101_INSTANCE_FXrpx9qY7FbU_type=content

4. Renal cancer gains new treatment

16/12/2016

ANVISA approves new therapeutic indication for the biological product Opdivo ® (nivolumab) indicated for the treatment of renal cancer. The approval was published in the Official Federal Gazette on December, 12, 2016. With the publication of its registration, Opdivo® will also be suitable for the treatment of advanced renal cell carcinoma after a previous anti-angiogenic therapy. It is already indicated for Monotherapy for the treatment of advanced melanoma, treatment of locally advanced or metastatic NSCLC with progression following platinum-based chemotherapy. Patients with EGFR or ALK mutations should have progressed after a treatment with anti-EGFR and anti-ALK before receiving Opdivo®. ANVISA also approved the registration of the new drug MEKINIST® (trametinib dimethylsulfoxide), in the pharmaceutical form of a coated pill. The drug is indicated as treatment for patients with non-resectable or metastatic melanoma with a mutation of BRAF V600. Link: http://portal.anvisa.gov.br/noticias?p_p_id=101_INSTANCE_FXrpx9qY7FbU&_101_INSTANCE_FXrpx9qY7FbU_groupId=219201&_101_INSTANCE_FXrpx9qY7FbU_urlTitle=cancer-renal-ganha-novo-tratamento&_101_INSTANCE_FXrpx9qY7FbU_struts_action=%2Fasset_publisher%2Fview_content&_101_INSTANCE_FXrpx9qY7FbU_assetEntryId=3136285&_101_INSTANCE_FXrpx9qY7FbU_type=content

5. Ministry of Health incorporates new drugs for the treatment of hyperparathyroidism

16/12/2016

Patients with secondary hyperparathyroidism, deriving from chronic kidney disease, will have two more drugs available at the Public Health System (SUS) from the beginning of 2017. The drugs Paricalcitol and Cinacalcet were incorporated by the Ministry of Health.

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In 2014, around 45.000 patients have shown an above-normal PTH level (beyond 300pg/ml) in Brazil, according to the census of the Brazilian Nephrology Society. To control the PTH level, the Ministry of Health endorses an initial treatment for the correction of calcium and/or phosphorus levels. In case the PTH level cannot corrected with these measures, patients must be treated with alfacalcidol or calcitriol, available in the Public Health System. If, even so, the PTH level stays above the recommended threshold, then the surgery to remove a part of or the entire parathyroid gland is indicated. Link: http://portalsaude.saude.gov.br/index.php/cidadao/principal/agencia-saude/26909-saude-incorpora-novos-medicamentos-para-hiperparatireoidismo

Drug advertisement and promotion

1. Sales in drugstores have grown by 42% in five years

12/12/2016

Within one year, a Brazilian consumes on average 700 doses of drugs bought at drugstores. This puts Brazil among the ten largest pharmaceutical markets in the world. And the numbers are expected to rise further, which would lift the country to the fifth position in the global ranking within three years, according to the Brazilian Association of the Pharmaceutical Research Industry, Interfarma, with data by Quintiles IMS. The numbers mirror a reality of self-medication, easy access to drugs, high investments in advertising, sectoral lobby and failed regulation. According to the Pharmaceutical Industry Union Sindusfarma, a further reason for this increase is the growing and aging population. Additionally, more people are concerned about health and access to drugs has increased in recent years due to the entry of generics. Link: http://www.interfarma.org.br/noticias/1152

Generics

1. Research shows the strength of generic drugs and the price sensitivity of the Brazilian customer

14/12/2016; 31/12/2016

The Febrafar Institute of Research and Continued Education (IFEPEC) released a study that shows that 45% of customers are prioritizing price to the detriment of the brand when buying drugs. The institute interviewed 4.000 customers all over Brazil at the moment they were leaving the drugstore after buying drugs. The research concluded that 97% of interviewed people bought the cheaper option of the drug. In these cases, generics were the choice for the majority of the customers: 37% of them bought generic drugs, 32% bought brand-name drugs and 31% bought both (generics or brand-name drugs) that were to be sold at a cheaper price.

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Moreover, it is believed that the customers see generics as a safe alternative for brand-name drugs, with the addition of a lower price, making them consider this option when buying. From every 4 buyers, 3 did not carry the medical prescription. When questioned, 74% stated a negative answer whereas only 26% said they had it with them. Additionally, the research shows that 72% bought the drugs, but only 24% bought exactly what they were going to buy. 31% had changed part of the purchase and 45% changed their drugs themselves or by the indication of a doctor. Links: http://febrafar.com.br/genericos-vencem-desconfianca/ http://febrafar.com.br/consumidores-preferem-genericos/

Treaties, international cooperation

1. Treaty signed to implement REPs

15/12/2016

ANVISA signed an agreement together with the Pan American Health Organization (PAHO) for the implementation of the REPs (Regulatory Exchange Platform Secured) in the Agency. The agreement formalizes the commitment of ANVISA to the initiative to develop REPs. This global platform is coordinated by PAHO and allows the exchange of non-public regulatory documents to promote convergence and harmonization among the countries. During the meeting, it was also announced that the Food and Drug Administration (FDA) and the Public Health Institution of Chile will join the group of National Authorities for Regional Reference. This group consists of authorities evaluated by PAHO that received the maximum qualification (Level IV), thus, assure that drugs produced and consumed in each of these countries reach the appropriate security, quality and efficacy level. It is composed by ANMAT (Argentina), ANVISA (Brazil), CECMED (Cuba), Cofepris (Mexico), FDA (USA), HC (Canada), Invima (Colombia) and ISP (Chile). The meeting was also used to discuss new ways to cooperate and develop global actions to map and remedy regulatory weaknesses.

Links: http://portal.anvisa.gov.br/noticias?p_p_id=101_INSTANCE_FXrpx9qY7FbU&_101_INSTANCE_FXrpx9qY7F

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http://portal.anvisa.gov.br/noticias?p_p_id=101_INSTANCE_FXrpx9qY7FbU&_101_INSTANCE_FXrpx9qY7F

bU_groupId=219201&_101_INSTANCE_FXrpx9qY7FbU_urlTitle=anvisa-integra-reuniao-das-autoridades-

nacionais-de-referencia-

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2. Ministry of Health invests R$ 443 Million for the productions of biological medicinal products

08/12/2016

The Ministry of Health will invest nearly R$ 443 Million per year for the technology transfer and acquisition of five biological medicinal products. The new Partnerships for Productive Development (PDP in Portuguese) were announced on December, 8 2016 and will reduce the costs of drugs and stimulate the national production. The new drugs are already distributed freely by the Public Health System. Moreover, they will be produced by four public labs and seven private companies by the end of the technology transfer procedure. Nowadays, the total of biological medicinal products represents only 4% of the quantity distributed by the Public Health System and 51% of the purchasing budget. They are in total 5 drugs: adalimumab and infliximab (Rheumatoid arthritis), filgrastim and rituximab (oncologic diseases) and somatropin (growth hormone). The Ministry of Health has 86 partnerships of productive development in effect. Among them are 18 public labs and 43 private labs for the development of 88 drugs, 4 vaccines and 13 health products. With this announcement, 7 new partnerships will be incorporated to the existing list. The PDPs’ aim is to transfer technology for the national production of drugs, inputs and strategic technologies for the health segment. The deadline for the project conclusion, containing the completion of the technology transfer procedure will be at most 10 years. Links: http://portalsaude.saude.gov.br/index.php/cidadao/principal/agencia-saude/26775-saude-investe-r-443-mi-para-producao-de-medicamentos-biologicos http://portalsaude.saude.gov.br/index.php/cidadao/principal/agencia-saude/26771-ministerio-da-saude-anuncia-investimento-para-producao-de-medicamentos-biologicos

Initiatives in the distribution and retail segment

1. Drug Disposal: Federal Pharmacy Council elaborates a proposal to revive the Sectoral Agreement

16/12/2016

The Working Group for Drug Disposal and Reverse Logistics of the Federal Pharmacy Council (CFF) elaborated a technical note in order to proceed with the Sectoral Agreement that involves three proposals presented by manufacturers, importers, distributors and retailers regarding reverse logistics of drugs. The Agreement did not receive an update or position from the Ministry of Environment since 2014.

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The CFF study presents the current scenario of drug disposal in Brazil and measures already taken regarding reverse logistics. The biggest impasse on the topic of reverse logistics is the lack of a specific legislation to determine final treatment and disposal of the collected drugs. According to the Group, the study should be presented in hearings at the Ministry of Health and the Ministry of Environment, as well as serve as a basis for discussions in Health Surveillance conferences in 2017. The Working Group was implemented by the CFF in October, 2016 to revive past activities regarding drug waste that have been realized since the release of the National Policy of Solid Residues. Link: http://www.cff.org.br/noticia.php?id=4253&titulo=Descarte+de+medicamentos%3A+CFF+elabora+proposta+para+resgatar+Acordo+Setorial

2. Brazilian postal service will distribute drugs for the Public Health System

28/12/2016

The Ministry of Health signed a contract for the transport of drugs and other products for the Public Health System with the Brazilian Post and Telegraph Company that won the bid due to best price. The change should reduce the costs for shipping the health product inputs to all regions of Brazil. The Brazilian postal service will start services for the Ministry of Health on February 24, 2017. The company is responsible for air and ground transportation of strategic inputs for the health sector, drugs and thermolabile – perishable or not – biologic or not, vaccines, kits for disasters, equipment, field hospitals, generators, food etc. This contract follows the contract with Voetur Cargas e Encomendas that had expired at the end of December, 2016. Therefore, the Ministry of Health made a public call for an emergency contract of 60 days. 40 institutions participated in the bidding proceedings. Only two companies presented a proposal, one of them being Voetur. The company will carry out the service until February 2017, and hand over the service to the Brazilian postal service. Link: http://portalsaude.saude.gov.br/index.php/cidadao/principal/agencia-saude/27061-correios-distribuirao-medicamentos-para-o-sus

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