Drug giants move in to block generics

Civil society organisations dealing with intellectual property rights have mounted a spirited attempt to block the European Union and US from introducing stringent patent rights that would block access to generic life-saving medicines.

A generic drug is a copy of a brand-name drug whose patent has expired. It is sold at a significantly lower price than the branded drug. In Uganda, 90% of all drugs are generics.

Denis Kibira, a medicines expert and advisor at Higher Education Partnership for Sustainability (HEPS-Uganda), says stringent patents could spell a death sentence to thousands of people living in poverty, who face life-threatening illnesses such as malaria, TB and HIV/Aids, as they would not be able to afford expensive, patented drugs. 

A nurse searching for dugs in a cabin-PHOTO/COURTESY

Currently, of the 1.3m people living with HIV in Uganda, 630,000 require anti-retroviral drugs (ARVs) and of these, 150,000 are children. The gap between supply and demand means that many Ugandans are unable to get the life saving ARVs even when they need them.

Trading away lives

As a member of the World Trade Organisation, Uganda adopted the Trade Related Aspects of Intellectual Property (TRIPS), a requirement to implement high standards of legal protection and enforcement of intellectual property rights of the original producer of a product.

According to the TRIPS agreement, least developed countries (LDCs) are supposed to enforce patents on all medicines by 2016. This would mean the end of all generic drugs. Patents guarantee the right to exclude others from making, using, offering for sale or selling the invention for 20 years from the date on which the application for the patent was filed.

But an interpretive statement of TRIPS, the Doha Declaration issued in November 2001, indicates that TRIPs should not prevent states from dealing with public health crises. It lifted patent restrictions to allow for production of cheaper generic medicines for HIV, TB and malaria.

Kibira, however, says that European pharmaceuticals have sought to roll back this provision by advocating for free trade and economic partnership agreements (FTAs) with developing countries such as India, Thailand and Brazil.

These agreements limit the gains for health rights made through the Doha Declaration which relaxed TRIPS, for example, the one being negotiated between the EU and India which would require India to trade away its ability to manufacture generic drugs. 

“The contentious provisions in the FTA would allow foreign companies to sue India over issues like price reductions on medicines and empower customs officials to seize generic medicines preventing them from reaching their destination,” Kibira explains. 

Access to medicines graphic by WHO

This is particularly worrying because India provides about 80% of the ARVs used to treat more than six million people in Africa, according to Medecins Sans Frontiers (MSF), not to mention cheaper drugs for other ailments.

“As per requirements under TRIPS, India grants product patents for drugs and pharmaceuticals while Uganda does not and these expansive laws may limit accessibility and affordability of cheap lifesaving drugs as Uganda does not have the capacity to provide drugs for its entire population,” says Moses Mulumba, executive director of the Centre for Health, Human Rights and Development (CEHURD).

Also, the provisions threaten Uganda’s opportunity to continue participating in trade and product development partnerships with India such as the one between CIPLA (Indian generic drug manufacturer) and Quality Chemicals Industrial Limited (QCIL) which has to some extent eased the accessibility and affordability of cheap drugs by Ugandans.

“Our partnership with CIPLA has boosted technological transfer, we have had more than 200 staff trained and we have also invested in research to continue producing ARVs and anti-malarials,” explains George Baguma, QCIL’s director of marketing.

Way Forward

Recently, the World Trade Organization granted LDCs an extension period till 2021 in which to enforce TRIPS.

“As a region with overwhelming capacity constraints in local pharmaceutical production and 80% of the population depending on generic drugs, this offer to extend the transition time illuminates how much more effort civil society needs to put in asking for an indefinite extension of pharmaceutical product patents,” said Mulumba.

Baguma says there is need for government to provide for compulsory licensing, enabling Uganda’s pharmaceuticals to secure licences that allow them to copy patented products and processes without fear of prosecution.