Thousands of Ugandans enrolled on antiretroviral treatment in Uganda risk an Aids drugs shortage unless a grace period placed on the manufacture of generic Aids drugs imposed under TRIPS, an international trade law, is extended beyond July 2013. According to Denis Kibira of the Health Rights NGO, HEPS-Uganda, almost 90 per cent of Aids drugs available on the Ugandan market are generic drugs from India.
A generic drug is an identical copy of a brand name. Under World Trade Organisation (WTO)’s TRIPS agreement, to which Uganda is a signatory, poor countries were given a transitional period to consume generic Aids drugs based on original formulas developed by mainly Western pharmaceutical companies such as Pfizer and Smith Kline Beecham, which invest heavily in developing new Aids drugs. For pharmaceutical products, this ban will take effect in 2016.
According to the WHO, ‘Developing countries are failing to make full use of flexibilities built into the World Trade Organisation’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to overcome patent barriers and, in turn, allow them to acquire the medicines they need for high priority diseases, in particular, HIV/Aids.
According to Mr Kibira, almost all Aids drugs used in Uganda are manufactured in India and Uganda under an international intellectual property law that permits drug manufacturers in developing countries to manufacture pharmaceutical products that imitate those originally made by Western pharmaceutical companies on account of public health emergencies in poor countries.
For developing countries such as India, the ban on manufacture of generic Aids drugs came into force in 2005 under the TRIPS agreement of the WTO whereas a similar ban on poorer developing countries such as Uganda will take effect in 2016 unless Uganda passes a national law that allows for extension of this deadline.
Pharmaceutical products have a deadline of 2016. UNAIDS,UNDAP and WHO have urged all developing countries to enact TRIPS ‘flexibilities’ or provisions with the international trade law that allows poor countries to use patented medicines under a public health emergency provision.
“Unless the Ugandan Parliament revisits and passes the Industrial Properties Bill, the permission to manufacture cheap generic ARV drugs will cease in 2016 with thousands affected since Quality Chemicals manufactures generic Aids drug,’’ said Moses Mulumba,Executive Director of CEHURD, a healthcare access rights NGO advocacy group.
With the expiry of the TRIPS grace period, the alternative in Uganda would be to buy these drugs much more expensively from the original Western manufacturers at prices beyond the reach of the majority Ugandan ARV user.
Aids triple-combination therapy, which costs $10,000 per patient per year in industrialised countries, can now be obtained from Indian generic drugs company, Cipla, for less than $200 per year. Generic Aids drugs enabled millions gain access to Aids treatment in poor countries. The 2013 and 2016 TRIPS deadlines threaten to reverse these gains and turn Aids treatment into a preserve of patients in rich Western world.
Recently, Dr Raymond Byarugaba, head of Uganda Aids Information Centre, announced that this year, there will be 150,000 new HIV infections in Uganda up from 130,000 last year and 100,000 in years before adding to the already rising number of those in need of antiretroviral treatment which they can’t access.
At the moment, passing the Industrial Properties Bill in Uganda, after amending it to take full advantage of the ‘flexibility’ in the TRIPS agreement, which would, inter alia, extend the grace period for manufacturing generic Aids drugs remains the best hope for the thousands on Aids treatment most of whom rely on generic drugs manufactured by Indian pharmaceutical companies such as CIPLA or its subsidiaries in Africa.
On Monday, November 14, the world marked 10 years since the DOHA Declaration, which secured a grace period for developing countries to implement patents for pharmaceutical products. Sadly, poor countries, including Uganda, have not taken full advantage of this grace period and this puts the lives of millions at stake as the clock ticks to the 2013 and 2016 deadlines.
Mr Zakumumpa is an HIV/Aids specialist at Makerere University and a key correspondent for the International HIV/Aids Alliance.