Pharmaceutical Executive Europe - November/December 2007 - (Page 28)

28 World Health Nov/Dec 2007 Pharmaceutical Executive Europe Developing Strategies for Developing Countries With the progress of HIV/AIDS treatment, the practice of making drugs available to developing countries has undergone a sea change. Anne V. Reeler and Joseph Saba review the lessons learned and propose a new model for doing business with these emerging economies. rior to the HIV/AIDS epidemic, it was generally accepted that, because of their high prices and the lack of healthcare infrastructure, many high-tech patented drugs could not be made available in developing countries. High prices were justified because of the research costs involved and the need for return on investment; consequently, most of the pharmaceutical industry took a “one size fits all” approach and kept their drugs at the same price in all markets. This model has been challenged profoundly by HIV/AIDS. The research-based industry has undergone ten turbulent years of lawsuits, activism and international pressure to make life-saving drugs available at low cost in developing countries. Most, if not all, of the research-based industry has complied with these expectations for HIV/AIDS drugs. There is now an expectation that drugs, whether for lifethreatening conditions or for chronic diseases, should be available and accessible in emerging economies and developing countries. Improvements in the delivery mechanisms for the newer drugs have been so substantial that patients no longer require hospitalization but can take life-saving oral drugs at home. Many of these life-saving drugs, however, are still too expensive. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement initially established 20-year patents on pharmaceutical products, but a provision allowed emerging economies to produce (or threaten to produce) P generic versions of patented drugs through compulsory licensing. Countries are supposed to seek approval from the patent holder, but this requirement can be waived in cases of national emergency or extreme urgency.1 Some governments have also used parallel importing, which means that governments are able to buy (generic) drugs from the cheapest source globally, but TRIPS does not address this. Emerging economies vs Big Pharma The real question for the research-based industry is what to do with emerging economies that may have some purchasing power but are unable to provide for the entire population. The track record is one of conflict and lawsuits. Both compulsory licensing and parallel imports have been used by governments of emerging economies. The Government of South Africa passed a law in 1997 to use both options and was sued by a group of pharma companies in 1998.2 The US was initially supportive of the lawsuit, but, under international pressure, later withdrew its support. After three years the companies gave up the lawsuit, having achieved nothing but a great deal of damage to their reputations. Brazil is another example of an emerging economy where the government has fought, and won, the battle for generics. In 2001 the dispute was between the Brazilian and the US governments. The Government of Brazil used a Brazilian law that stipulates that all

Table of Contents for the Digital Edition of Pharmaceutical Executive Europe - November/December 2007

Pharmaceutical Executive Europe - November/December 2007
Contents
From the Editor
News and Analysis
Calendar
Brussels Report
A Year in Pharma
Working With IQWiG
Developing Strategies for Developing Countries
Due Pharmacovigilance
Streamlining Synergies
A New Europe for CROs
The Mix
Last Word

Pharmaceutical Executive Europe - November/December 2007