Uganda: Worry for thousands as delay in reforming critical bill may render ARV drugs illegal

“We no longer fear AIDS. Eddagala gyeriri e Mulago [drugs are available at Mulago Hospital],” says Moses, 32, who tells me he has had three sexual partners in the last month and did not use condoms with any of them.

Many Ugandans take antiretroviral treatment (ART) for granted. This ARV complacency has been partly blamed for the recent spike in new HIV infections. Uganda’s HIV prevalence rates have risen from 6.7% in 2005 to the current 7.3%.

Because most ART in Uganda has been funded by the American tax payer, with PEPFAR paying for as much 85% of all HIV treatment costs in Uganda, you would regard financial sustainability as the challenge to continued access to treatment in the country.

But you would be mistaken, for it is intellectual property rights that could prove the biggest threat to access.

Intellectual property rights and access to ARVs

According to Dennis Kibira, medicines advisor at the Coalition for Health Promotion and Social Development (HEPS) Uganda, 90% of antiretrovirals (ARVs) in Uganda are generic. A generic drug is an identical copy of a branded one that is usually developed and manufactured by innovator pharmaceutical giants such as Pfizer and Norvatis. Pharmaceutical giants invest millions in developing and marketing new drugs. These are costs that generic drug manufacturers don’t incur, which means branded drugs are many times the cost of generics.

“Unless the Ugandan parliament revises and re-introduces the Industrial Properties Bill (2009), the permission to manufacture cheap generic ARV drugs will cease in 2016 with thousands affected since Quality Chemicals [Ugandan pharmaceutical company] manufactures generic AIDS drugs,’’ said Moses Mulumba, Executive Director of the Centre for Health Human Rights and Development (CEHURD).

India, which supplies most of Uganda’s HIV drugs, has developed a thriving generics industry, leading to it being dubbed ‘the pharmacy of the developed world’ for the low cost of its generic drugs. This is especially true for its antiretrovirals, some of which cost as little as a tenth of the brand price.

The best hope: the revision of the 2009 Industrial Properties Bill

For middle income countries such as India, the ban on the manufacture of generic HIV drugs came into force in 2005 under the World Trade Organisation’s Trade Related Intellectual Property Rights (TRIPS) agreement whereas a similar ban on lower income countries such as Uganda will take effect in 2016. However, were the Ugandan parliament to revise and pass its 2009 Industrial Properties Bill it would serve, among other things, to extend this grace period. This remains the best hope for the thousands on ARVs in Uganda.

However, should the TRIPS grace period expire without action being taken, Uganda will have no alternative other than to buy ARVs much more expensively from the original Western manufacturers. According to the World Health Organisation, developing countries are failing to make full use of flexibilities built into the TRIPS agreement to overcome patent barriers to acquire the medicines they need for high priority diseases, in particular HIV and AIDS.

For many, the revision of the bill cannot happen quickly enough. A dejected Gertrude Namusisi, 42, who is living positively with HIV, said: “There are few priorities before parliament which should take precedence over our very lives as Ugandans. If I was an MP this bill would be the most important item on the agenda because it affects millions of Ugandans. Look at how many Ugandans are getting infected everyday and how many will need these drugs.’’

In November last year, a consortium of NGOs led by CEHURD took out a half page newspaper appeal to Justice Minister Kahinda Otafiire to seek his support in revising the bill before it is passed by parliament.

“The bill left our desk. We did our part. It is now before parliament, specifically before the legal affairs committee,’’ a source within the Ministry of Justice said.

The Industrial Properties Bill has not been enacted since 2009 and so lapsed under the eighth session of parliament. The bill has now been inherited by the current parliament. The Ministry of Justice has indicated that a bill should not spend more than 45 days before a parliamentary committee.

Mariam Akiror, of HEPS-Uganda, said: “As stakeholders we are waiting for the public hearing on this bill. However, since April this year when the expert report on this bill was released by Ministry of Trade there have been no engagements on this bill by the ninth parliament.”

Akiror of HEPS Uganda, added that the current bill must be revised otherwise it may do “more harm than good.” In the current bill, the government needs to obtain the consent of the patent holder before making a generic drug yet the TRIPS flexibilities permits poor countries to make a copy without permission on account of a public health emergency. Akiror said that even the status quo would be preferable to this as under the current legal regime ‘big pharma’ is hard-pressed to enforce their patents.

Charles Birungi, of UNDP (Uganda), argued that the current bill is about the “enforcement of certain types of intellectual property rights”, but these are private rights enjoyed mainly by Western pharmaceutical giants. Revising the bill would be a boost for Ugandan pharmaceutical industries such as Quality Chemicals as it would legalise their production of generics.

A Uganda Law Reform Commission official said: “Laws take time to enact as you have to follow so many procedures including the draft being presented before cabinet and even [the] formulating of policy and objectives, and parliament has many priorities.”



  • comment-avatar
    Jerry 4 years

    Pliz MPs help us we cant let our people die as we see. This is the time 4 us to wake up and set up research facilities for some of us to develop our drugs and get more earnings