Uganda leads push for permanent waiver on drug patents

Monday November 09 2015

In the race against killer diseases like malaria and HIV, the world’s poor countries are largely dependent on generic drugs, according to data from UNDP and UNAids. PHOTO | FILE

Uganda is leading the world’s least developed countries (LDCs) in the ongoing showdown talks at the World Trade Organisation headquarters in Geneva, where America remains the only powerful country still refusing to grant a permanent waiver on patents on medicines.

Joining Uganda in demanding that LDCs remain protected from the enforcement of patents and other intellectual property rights on the manufacture of pharmaceuticals are the Asian states of Nepal and Bangladesh.

At issue is the impending closure, at the end of this year, of the 10-year window that WTO granted poor countries in 2006 to continue manufacturing generic drugs using the intellectual property rights of established companies from the West.

Closing this window would give developed world countries an unprecedented flexing of their muscles to control the global pharmaceutical industry by enforcing patents.

The upshot is that poor countries would be denied the ability to manufacture cheaper generic drugs that are a lifeline for most people in LDCs.

Global actors, including the European Commission most recently, have come out in support of the LDCs’ push for a permanent waiver in a bid to improve global health indicators.


“The Commission today agreed to support the LDCs’ call for easier access to cheaper medicines by means of an indefinite exemption from WTO intellectual property rules for pharmaceuticals,” EU Commissioner for Trade Cecilia Malmstrom said, in a September 10 statement.

“This exemption allows generic medicines to be imported, and produced locally, regardless of patents, for example when licences are not available.”

Earlier this year, UN agencies World Health Organisation, United Nations Development Programme and UNAids, as well as medical humanitarian organisation Medecins Sans Frontieres, had also lent their support to poor countries but the Obama administration continued to stand in the way of LDCs.

“Currently, LDCs who are members of the WTO are not required to apply most of the substantial rules on the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement until July 2021,” WHO said in June this year.

“In particular, they have no obligation to provide any protection for clinical test data or to grant patents, including on pharmaceutical products or processes.”

US plays hardball

In the October 15-16 meeting of the WTO Council on TRIPS in Geneva, US trade representative Michael Punke said his country could only offer another 10-year transition period during which the LDCs should be weaned from protection.

The TRIPS Council reconvened on October 28, with the hope that the LDCs would get a breakthrough before the end of October, but a source told The EastAfrican that the US was not ready to cede any ground when it returned to the negotiations table.

“They will be intensifying their pressure on Uganda, Nepal and Bangladesh, the main negotiators on behalf of the LDCs,” a source said.

But after sustained pressure from global health rights activists who had criticised the US as being “on the wrong side of the debate,” there was some movement.

A source familiar with the discussions in Geneva told The EastAfrican that by press time, the LDC negotiators and their US counterparts were still deadlocked at an extension period of 17 years, after the current waiver elapses.

Uganda’s permanent representative to WTO Christopher Onyanga Aparr has been chairing the LDC Group’s push, which also has the support of countries that are non-LDC like India and Kenya.

Indian companies, for instance, have found fertile ground in poor countries to establish factories that manufacture generic drugs.
Enforcement of patents would deal a blow to such companies as Uganda-based Indian investment Cipla Quality Chemicals Ltd, which manufactures generic antiretrovirals (ARVs) and anti malaria drugs.

In August this year, Kenya’s President Uhuru Kenyatta toured Cipla Quality Chemicals and a month earlier, President Edgar Lungu of Zambia — also an LDC — too visited the generic drugs factory in Kampala.

Kenya and Zambia are both members of the regional economic bloc Common Market for Eastern and Southern Africa (Comesa), which has been actively seeking extension of the patents beyond 2015, saying that its member states can develop capacity within that extension period and engage in local manufacturing of essential drugs to ensure continued access for its market of 490 million.

Here is why: Comesa covers over 80 per cent of sub-Saharan Africa – the world’s most HIV/Aids affected region; in 2009, the bloc had a total import bill of pharmaceutical products worth $2.6 billion against total exports of $276 million.

Generic drugs

Presidents Kenyatta and Lungu spoke in support of generic drugs manufacturing within the region, and promised to procure and source pharmaceutical products from the Uganda-based drugs maker, which was established in 1997 by local investors as Quality Chemicals Ltd, but in 2005 brought on board Indian firm Cipla.

In 2013, Cipla, the world’s largest generic drugs manufacturer, increased its stake in the firm to 51 per cent.

In the race against killer diseases like malaria and HIV, the world’s poor countries are largely dependent on generic drugs, according to data from UNDP and UNAids.

The two UN agencies argue that because of availability of drugs manufactured by LDCs, the percentage of people living with HIV who are not receiving ARV has been reduced from 90 per cent in 2006 to 63 per cent in 2013.

“LDCs and developing countries have effectively used transition periods to scale up access to treatment for HIV and its co-infections by importing or manufacturing lower-cost generic medicines,” say UNDP and UNAids in a May 2015 statement.

The UN agencies also revealed that medicines such as sofosbuvir used to treat chronic hepatitis C, remains a grave challenge among LDCs because of high costs — as much as $84,000 for a 12-week course in developed countries.

Generic licences have meant lower prices being offered by the patent holder in some developing countries but would still place a considerable burden on health budgets. A company in Bangladesh, making use of its LDC status, has launched its own version for $900 for the 12-week course.

With time running out for a deal in Geneva as the US continues to play hardball, it is expected that the upcoming WTO Ministerial conference in Nairobi later this year will address the LDCs position for a final deal, before the current window slams shut at the end of this year.

Moses Mulumba, the executive director of Centre for Health, Human Rights and Development, said it makes sense that poor countries get a permanent waiver because the 10-year transition the US is offering is too short a period for LDCs to develop the capacity required.

Moreover, the LDCs’ push is guaranteed under Article 66 of the TRIPS Agreement, that a once a duly motivated request is made by the LDCs, it must be granted.  

“What’s 10 years? A permanent waiver is the only approach that provides the legal certainty needed by generic suppliers so that LDCs will remain a viable market for newer medicines,” said Mr Mulumba.