Generic drugs in Brazil: historical overview and legislation

The Brazilian generic drugs policy was implemented in 1999 with the aim of stimulating competition in the market, improve the quality of drugs and improve the access of the population to drug treatment. The process of implementing this policy allowed the introduction and discussion of concepts that had never before been used in the context of drug registration in Brazil: bioavailability, bioequivalence, pharmaceutical equivalence, generic drugs, biopharmaceutical classification system, biowaiver. The present article provides definitions for these concepts in the context of Brazilian legislation as well as a historical and chronological description of the implementation of the generic drugs policy in Brazil, including a list of current generic drug legislation. This article contributes to the understanding of the Brazilian generic drugs policy and facilitates the search for information concerning the legal requirements for registration of drugs in Brazil.

New Strategic Direction for Alcohol and Drugs 2006-2011 (NI) - Consultation response

The Institute of Public Health in Ireland welcomes the opportunity to comment on the consultation paper on the New Strategic Direction for Alcohol and Drugs 2006-2011 (NSD). We particularly welcome the approach taken in the strategy, which, from the conceptual base of the Programme Logic Approach, is firmly based on desired outcomes and the pathways leading to them. The Institute aims to improve health in Ireland, North and South by working to combat health inequalities and influence public policies in favour of health. The Institute applies a holistic model of health which emphasises a wide range of social determinants, including economic, environmental, social and biological factors, as well as the health and social services. The Institute’s work is based on the premise that improving health and reducing health inequalities can only be achieved through addressing these broader determinants of health.

National Drugs Strategy 2009-16: Implementation of Actions Progress Report End 2012

The National Drugs Strategy 2009-16 is a cross cutting area of public policy and service delivery. It is based upon a co-ordinated approach across the full range of Government Departments and Agencies involved in delivering drugs policy. The overall objective of the Strategy is to tackle the harm caused to individuals, families and communities as a result of problem drug and alcohol use through the five pillars of supply reduction, prevention, treatment, rehabilitation and research. The progress achieved across the 63 Actions of the National Drugs Strategy by Government Departments and Agencies is reported here. Click here to download PDF 295kb  

2006 Drugs estimate refuels debate on governance, Issue 17, Spring 2006

In November 2005 €34.027 million was voted for the Drugs Initiative, which funds the local and regional drugs task forces, and the Young People’s Facilities and Services Fund (YPFSF), in 2006 – an 8 per cent increase on the allocation for 2005 and ‘well in excess of inflation’ according to the government. The community sector strongly criticised this estimate, calling for an additional €8 million to €15 million, to fund the projects identified following the creation of the Emerging Needs Fund in January 2005. In February 2006, the government revised its drugs estimate upwards by a further €8.979 million. As well as criticising the 2006 drugs estimate, the community sector raised a series of concerns with regard to governance – the rules, processes and behaviour that affect the way in which powers are exercised4 – or, in short, decision-making with regard to drugs policy in Ireland.This resource was contributed by The National Documentation Centre on Drug Use.

Debate sobre política de drogas a través de la opinión en cuatro medios colombianos (2009-2013)

Este trabajo de grado aborda la contribución del periodismo en la configuración del debate en Colombia sobre política de drogas, a través de un análisis de contenido a las columnas y editoriales publicadas entre 2009 y 2013 en cuatro medios de referencia del país. Se identificaron los perfiles de quienes participaron, los argumentos y las políticas defendidas que plantearon, y la manera como presentaron sus opiniones en El Espectador, El Tiempo, La Silla Vacía y Semana. El desarrollo de la discusión en los textos demuestra una evolución respecto al tema en la medida que hay una transformación del paradigma punitivo hacia un camino menos restrictivo frente a la producción, el tráfico y consumo de drogas ilícitas. Se sugiere que los hechos coyunturales motivaron en parte dicho cambio al ejercer influencia en los giros y la visibilidad que toma el debate dentro de la prensa.

Produção descentralizada de medicamentos essenciais no Instituto de Tecnologia em Farmacos do Estado do Rio de Janeiro: um diagnostico estrategico de sua implementação

Nesta dissertação procura-se discutir a política de descentralização da assistência fanna-.;êutica no que diz respeito à produção e a distribuição de medicamentos. Para tanto, efetuou-se um estudo de caso em Far-Manguinhos / FIOCRUZ analisando sua estrutura organizacional e administrativa, assim como as estratégias utilizadas para implementar o processo de descentralização preconizado pelo SUS. Usou-se como referencial teórico artigos clásicos que contextualizam a realidade do setor farmacêutico nacional e mundial. O estudo se desdobra através da evolução política do setor da saúde no Brasil, com ênfase na política de medicamentos adotada a partir da criação da Central de Medicamentos - CEME, até a atualidade. Ao final são feitas algumas sugestões que poderão nortear outras discussões sobre assistência farmacêutica no Brasil.

La transformación de la política antidrogas de Estados Unidos y su incidencia en la cooperación colombo-estadounidense en la lucha contra las drogas (2010-2014).

Con la llegada del demócrata Barack Obama a la presidencia de Estados Unidos, se inició un proceso de transformación de la política antidrogas estadounidense, lo cual, impactó en el ámbito doméstico y exterior, en ése último, especialmente en cuanto cooperación refiere. Considerando lo anterior, la investigación analiza cómo la transformación de la política antidrogas de Estados Unidos ha incidido en la cooperación colombo-estadounidense en materia de lucha contra las drogas. Para ello, se estudia la transformación del modelo estadounidense, se identifica la evolución de la cooperación contra el narcotráfico entre los dos Estados en el periodo 2009- 2014 y se examina la incidencia de la transformación de la política estadounidense antidrogas en la política antidrogas de Colombia.

Workplace Drugs and Alcohol Policies - Example of a Model Policy (PDF 113 KB)

The Workplace Drugs and Alcohol Policy aims to contribute to a safe, healthy and productive work environment by: • Preventing drugs and alcohol problems through awareness raising; • Identifying problems at the earliest stage; • Offering support to those who have a problem. The policy has been developed in conjunction with our employees, their representatives and management and applies equally to all staff including all levels of management. åÊ

Drugs, law enforcement, and foreign policy : hearings before the Subcommittee on Terrorism, Narcotics, and International Communications and International Economic Policy, Trade, Oceans, and Environment of the Committee on Foreign Relations, United States Senate, One Hundredth Congress, first session.

"February 8, 9, 10, and 11, 1988"--Pt. 2.

``This is your brain on drugs'': The public policy of anti -drug programming. An exploratory analysis of media and other sources of drug information for adolescents

In the 1980s, government agencies sought to utilize research on drug use prevention to design media campaigns. Enlisting the assistance of the national media, several campaigns were designed and initiated to bring anti-drug use messages to adolescents in the form of public service advertising. This research explores the sources of information selected by adolescents in grades 7 through 12 and how the selection of media and other sources of information relate to drug use behavior and attitudes and perceptions related to risk/harm and disapproval of friends' drug-using activities.^ Data collected from 1989 to 1992 in the Miami Coalition School Survey provided a random selection of secondary school studies. The responses of these students were analyzed using multivariate statistical techniques.^ Although many of the students selected media as the source for most of their information on the effects of drugs on the people who use them, the selection of media was found to be positively related to alcohol use and negatively related to marijuana use. The selection of friends, brothers, or sisters was a statistically significant source for adolescents who smoke cigarettes, use alcohol or marijuana.^ The results indicate that the anti-drug use messages received by students may be canceled out by media messages perceived to advocate substance use and that a more persuasive source of information for adolescents may be friends and siblings. As federal reports suggest that the economic costs of drug abuse will reach an estimated $150 billion by 1997 if current trends continue, prevention policy that addresses the glamorization of substance use remains a national priority. Additionally, programs that advocate prevention within the peer cluster must be supported, as peers are an influential source for both inspiring and possibly preventing drug use behavior. ^

Evaluating health policy and legal responses : how to reduce barriers and improve access to orphan drugs for rare diseases in Canada

Abstract : Rare diseases are debilitating conditions often leading to severe clinical manifestations for affected patients. Orphan drugs have been developed to treat these rare diseases affecting a small number of individuals. Incentives in the legal framework aimed to recoup the research and development cost of orphan drugs for pharmaceutical companies have been implemented in the United States and the European Union. At the present time, Canada is still lacking a legal and policy framework for orphan drugs. Several problems at the federal and provincial levels remain: lack of research funds for rare diseases, discrepancies on orphan drug policies between provinces, difficulties to access and reimburse these high price drugs. Recommendations and measures are proposed, such as a pan-Canadian (national) scientific committee to establish evidence-based guidelines for patients to access orphan drugs uniformly in all provinces with a disease specific registry, a formal agreement for a centralized Canadian public funding reimbursement procedure, and increasing the role of “guardian” for prices by the Patented Medicines Review Board in Canada. These recommendations and measures will be beneficial for the implementation of a policy framework for orphan drugs in Canada.

Application of a policy framework for the public funding of drugs for rare diseases

BACKGROUND: In many countries, decisions about the public funding of drugs are preferentially based on the results of randomized trials. For truly rare diseases, such trials are not typically available, and approaches by public payers are highly variable. In view of this, a policy framework intended to fairly evaluate these drugs was developed by the Drugs for Rare Diseases Working Group (DRDWG) at the request of the Ontario Public Drug Programs. OBJECTIVE: To report the initial experience of applying a novel evaluation framework to funding applications for drugs for rare diseases. METHODS: Retrospective observational cohort study. MEASURES: Clinical effectiveness, costs, funding recommendations, funding approval. KEY RESULTS: Between March 2008 and February 2013, eight drugs were evaluated using the DRDWG framework. The estimated average annual drug cost per patient ranged from 28,000 to 1,200,000 Canadian dollars (CAD). For five drugs, full evaluations were completed, specific funding recommendations were made by the DRDWG, and funding was approved after risk-sharing agreements with the manufacturers were negotiated. For two drugs, the disease indications were determined to be ineligible for consideration. For one drug, there was insufficient natural history data for the disease to provide a basis for recommendation. For the five drugs fully evaluated, 32 patients met the predefined eligibility criteria for funding, and five were denied based on predefined exclusion criteria. CONCLUSIONS: The framework improved transparency and consistency for evaluation and public funding of drugs for rare diseases in Ontario. The evaluation process will continue to be iteratively refined as feedback on actual versus expected clinical and economic outcomes is incorporated. © 2014 Society of General Internal Medicine.

Problems in the regulatory policy of the drug market

OBJECTIVE Analyze the implementation of drug price regulation policy by the Drug Market Regulation Chamber.METHODS This is an interview-based study, which was undertaken in 2012, using semi-structured questionnaires with social actors from the pharmaceutical market, the pharmaceuticals industry, consumers and the regulatory agency. In addition, drug prices were compiled based on surveys conducted in the state of Sao Paulo, at the point of sale, between February 2009 and May 2012.RESULTS The mean drug prices charged at the point of sale (pharmacies) were well below the maximum price to the consumer, compared with many drugs sold in Brazil. Between 2009 and 2012, 44 of the 129 prices, corresponding to 99 drugs listed in the database of compiled prices, showed a variation of more than 20.0% in the mean prices at the point of sale and the maximum price to the consumer. In addition, many laboratories have refused to apply the price adequacy coefficient in their sales to government agencies.CONCLUSIONS The regulation implemented by the pharmaceutical market regulator was unable to significantly control prices of marketed drugs, without succeeding to push them to levels lower than those determined by the pharmaceutical industry and failing, therefore, in its objective to promote pharmaceutical support for the public. It is necessary reconstruct the regulatory law to allow market prices to be reduced by the regulator as well as institutional strengthen this government body.