Effect of free trade agreements on pharmaceutical market competition: The case of the 2009 US-Peru free trade agreement and its implementation as national drug policy.

Free Trade Agreements (FTA) are controversial for threatening essential aspects of health, especially access to affordable medicines. The US-Peru FTA required changes in the Peruvian pharmaceutical legislation that resulted in the implementation of the National Drug Policy (NDP) of 2009. The NDP included more robust technical requirements for registration, a Peruvian Good Manufacturing Practices certificate, a longer timeline for drug registration, and an increase in registration fees. This study evaluated the impact of the FTA on the number of registrations and competition in the Peruvian pharmaceutical market. Data for the period January 2005 to April 2014 were provided by the Peruvian drug regulatory authority (Dirección General de Medicamentos, Insumos y Drogas, DIGEMID). A total of 31,114 pharmaceutical products with unique registration numbers were evaluated. Brand drug new registrations decreased from 1789 in 2005 to 455 in 2013, and the number of generic registrations decreased from 621 in 2005 to 114 in 2013. Brand re-registrations also decreased from 714 in 2005 to 58 in 2013. There were 228 brand products awaiting registration in 2009 and 1,908 in 2013. The proportion of products awaiting registration was three times greater for brand than for generic products in 2009-2013. Registration of brand and generic medicines significantly declined after the implementation of the US-Peru FTA in 2009. The decline in the number of registrations was associated with more robust technical requirements, a longer DIGEMID registration timeline, and an increase in registration fees. The stronger registration requirements are expected to increase the quality of the drugs marketed in the country, but also less competition and a reduction in domestic registrations.

Access to essential drugs in Guyana: a public health challenge.

Guyana's pharmaceutical sector faces major challenges that limit access to essential drugs. This study analyzes Guyana's drug policy and regulation, public financing, and drug procurement and delivery. The study also identifies main barriers to drug access and proposes alternatives to strengthen the country's public health functions. Data were collected from the country's regulatory agencies, public procurement agency, pharmacies, wholesalers, and pharmaceutical companies. The information was supplemented with interviews with a convenient sample of Guyanese health authorities and stakeholders. Data were also compiled from scientific databases, and web pages of the country's Ministries of Health, Commerce and Finance, the Bureau of Statistics, and international organizations. Major barriers to drug access include: (1) lack of national drug policy and regulation, and limited role of the regulatory authority; (2) inefficient drug selection and irrational drug use; (3) insufficient financial resources and lack of drug pricing policy; (4) inefficient planning and managing public supply system; (5) deficient epidemiological and information systems; and (6) inadequate infrastructures and human resources shortage. Improving drug access in Guyana requires the strengthening of the country's public health functions and the implementation of a national drug policy and pricing policy, streamlining the drug financing, procurement, and planning and managing drug supply; and adequate infrastructures and human resources.

Analysis of the impact of the Uruguay Round Agreements Act on pharmaceutical patents.

The Uruguay Round Agreements Act (URAA) was enacted by the United States Congress in 1994. The URAA provided substantial modifications to the framework for U.S. patent law that came into effect January 1, 1953. Changes in patent regulation are especially important in the pharmaceutical sector because the patent system determines, in large part, the reward that an inventor can derive from discovery of a new drug. Most pharmaceutical patents are classified as utility patents. Pharmaceutical patents may include claims for the active ingredient per se, for the formulation of the active ingredient for use as a pharmaceutical, for therapeutic indications and uses, and for methods of manufacturing the drug. The U.S. has a First-to-Invent system to establishing the right of priority of an invention, but most countries have a First-to-File priority system. The First-to-Invent system allows for public disclosure of inventions prior to patent filing. In contrast, the First-to-File system encourages early filing of patent applications. In both systems, filing an application for a patent as soon as the drug is discovered allows inventors to obtain an earlier date of invention relative to potential competitors and establish the right of priority over the invention.

Negotiating antiretroviral drug prices: the experience of the Andean countries.

OBJECTIVES: This study analyses the effect of the Andean countries' June 2003 negotiation of antiretroviral drug (ARV) prices. The objectives were to assess the problems faced during the negotiation process, to evaluate the impact of the negotiation on ARV prices, and to identify factors that could make it difficult for countries to implement the results of the negotiation. METHODS: Price information of ARVs purchased by public programmes during 2004 was collected from the ministries of health. A survey of the ministries of health was conducted using a questionnaire with information related to the countries' health care and drug regulations and policies. Interviews with a convenient sample of key Andean health authorities and other stakeholders were also conducted. RESULTS: Study results show that the negotiation did achieve lower prices and higher quality and bioequivalence standards for ARVs. However, in general, the public health care programmes of the six countries analysed did not purchase ARVs from the companies that participated in the negotiation, nor did they base purchases on the prices or quality and bioequivalence criteria established in the negotiation. Prices paid by the Andean countries' public programmes in 2004 were a weighted average of 65% higher than the negotiated prices; and this difference in negotiated prices vs. actual prices represented 39.5% of the programmes' ARV expenditures in 2004, or US$18 million in ARV expenditures. CONCLUSION: The successful development and implementation of multinational price negotiations requires that participant countries coordinate pharmaceutical regulations and policies, and pool procurement processes.