UNAIDS has released a new policy brief to help countries make intellectual property rights work for them, amid growing concern that an impending free trade agreement between the European Union (EU) and India could threaten the world's supply of generic antiretroviral (ARV) drugs.
The World Trade Organization's Trade Related Aspects of Intellectual Property Rights (TRIPS) allows countries to override patents - for public health purposes - by issuing "compulsory licenses" that enable the generic manufacture of drugs still under patent.
The UNAIDS brief, published on 15 March, noted that few developing countries had exercised this right and cited a lack of capacity to deal with the complicated legal paperwork required. Nevertheless, the flexibility afforded by TRIPS has brought increased competition, helping to lower the cost of first-line generic ARVs by as much as 99 percent in the last decade.
Recent changes in World Health Organization (WHO) HIV treatment guidelines substituted stavudine, a cheaper ARV, for tenofovir, a more expensive one, making it even more important for countries to take advantage of TRIPS to keep treatment costs low and extend coverage.
The UNAIDS paper - co-authored by UNAIDS, WHO and the United Nations Development Programme (UNDP) - aims to help countries improve their access to generic ARVs by using TRIPS.
It also provides successful case studies from countries like Thailand, Brazil and Rwanda, which have used TRIPS to negotiate lower ARV prices, and recommends that governments adapt their national legislative frameworks and develop a domestic pharmaceutical production capability.
African activists speak out
According to UNITAID, an international facility for purchasing ARVs, India manufacturers most of the generic ARVs used in low-and middle-income countries, but African activists maintain that ongoing free trade talks between the EU and India will limit access to these drugs.
The EU is pushing for data exclusivity, which means Indian generics manufacturers would no longer be able to use existing drug trials to make identical generic drugs. Instead, they would be required to conduct their own clinical trials, delaying the access of poor countries to such drugs for several years. EU officials said clauses in the free trade agreement would take into consideration India’s role in producing generic medicines for the developing world.
"[Data exclusivity provisions] would apply even in cases where compulsory licenses have been issued to allow the sale of generic medicines during the life of a patent," said Jonathan Berger, a researcher at SECTION27, a South African human rights group, in a
joint statement on 9 March by SECTION27, international relief agency Medicines Sans Frontiers (MSF), and the South African AIDS lobby group, Treatment Action Campaign.
"Their existence threatens to undermine public health safeguards and flexibilities that are necessary to allow for the production and export of affordable medicines from India," Berger maintained.
More than 80 percent of ARVs dispensed in MSF programmes worldwide come from India, said Mara Kardas-Nelson, of MSF's Campaign for Access to Essential Medicines.
|If there is no access to medicines, you can't get the right to health. If you can't get your right to health, then they are sending you to the grave|
Allan Maleche, a lawyer and a member of the Kenya Ethical Legal Network on HIV & AIDS. (KELIN), said the free trade agreement could also bring with it patent extensions that would give the original makers of a drug up to 40 years of exclusive control over
formulations, and broaden the scope of enforcement measures, such as drug seizures, to safeguard the interests of patent holders - all bad news for access to generic medicines.
"If there is no access to medicines, you can't get the right to health," he noted at a presentation on intellectual property rights at a recent UNAIDS regional consultation in Johannesburg, South Africa. "If you can't get your right to health, then they are sending you to the grave."
Maleche's native Kenya used parallel imports as part of the mechanism’s
flexibility to drive down ARV costs by about 90 percent in 2001. Parallel importing allows countries to import medicines from middlemen who may not be the original manufacturer or patent-holder, but who have procured drugs abroad and can resell them to a country at a lower price than that offered directly by the patent holder.
Rwanda was the first country to use the WTO's special provisions to obtain compulsory licenses for Canadian-produced generic, fixed-dose combination ARVs. Canada gave Apotex, Inc., its largest pharmaceutical company, a compulsory export licence to produce a generic fixed-dose ARV for Rwanda without permission from the patent holders.
However, there are indications that many African countries may not have the technical expertise to fully understand intellectual property rights. Maleche noted that legislation against counterfeit drugs in Kenya and Tanzania confused generics with imitation or fake medicines.
He said there were fears that measures meant to crack down on dangerous counterfeit medicines could also affect access to legitimate generics.
The East African Community (EAC), an intergovernmental body comprising Kenya, Tanzania, Burundi, Rwanda and Uganda, is in the process of adopting a similar anti-counterfeit law that would apply automatically in all EAC member states.