Access to antiretroviral (ARV) drugs to fight HIV is a critical component of efforts to stem the tide of the disease. Until the early 2000s and the inauguration of the US President’s Emergency Plan to Fight AIDS (PEPFAR),⁽²⁾ whose ambition is to provide ARVs to Africans in particular, these drugs were largely out of reach to those most vulnerable to infection. Although access is still far from the UN and Millennium Development Goal (MDG) of ‘universal’ (pegged at 80% of those who qualify for drugs – a standard that is itself subject to change), it is much better than it was; but the question now stands, will such progress continue, or will it be stalled?

As this brief introduction notes, access to ARVs in Africa is premised largely on the largess of external donors: foreign governments, international organizations and private foundations. In recent years, local governments have also stepped up to the plate and are funding an increasing share of the financial burden associated with procuring, delivering and monitoring drug interventions. Is this arrangement sustainable? What stands it in good stead? What threatens to derail it? This CAI discussion paper explores some of the current drug deals being considered in the global forums that lay down the rules of trade and thus determines Africans’ access to life-saving medications. It delves further into the opportunities and challenges for the continent’s fight against the HIV & AIDS pandemic. Finally, it concludes with some recommendations for what can be done to assure drug access – and to boost overall efforts to eradicate HIV & AIDS.

Access to drugs in Africa: theory and practice

In theory, access to life-saving drugs such as ARVs, is protected under the World Trade Organization’s (WTO) Trade-Related Intellectual Property (TRIPS) agreement. TRIPS stipulates that in the case of a national emergency, such as is arguably the case in countries where HIV prevalence is above 1% of the general population – the definition of a generalised epidemic – governments who are not capable of producing their own drugs are allowed to invoke voluntary or compulsory licenses as well as to proffer parallel imports to source the medications necessary for their infected citizens to survive.⁽³⁾

According to Ellen ‘t Hoen, former Policy and Advocacy Director of the Médecins Sans Frontières (MSF) campaign for the access to essential medicines and currently the Senior Intellectual Property (IP) Advisor at UNITAID, which sources and pools funding for ARVs, “between 2001 and end of 2007, 52 developing and least-developed countries have issued post-Doha compulsory licenses for production or import of generic versions of patented medicines.”⁽⁴⁾ Most prominent among these were ARVs. “Many countries have also used the flexibilities as leverage in price negotiations with patent-holding pharmaceutical companies.”⁽⁵⁾

However, despite these ostensive theoretical ‘rights’, and their occasional successful invocation in practice, more commonly “efforts by countries like South Africa and Brazil to deploy TRIPS flexibilities in the face of genuine AIDS ‘emergencies’ in their populations were challenged by both the United States and global pharmaceutical corporations in different forums.”⁽⁶⁾ Whereas Brazil ‘won’, South Africa ‘lost’, and went on to pursue a controversial strategy of not procuring ARVs until both internal and external pressure groups and actors forced the Government’s hand. In the meantime, according to a study conducted by Harvard University, some 300,000+ people had died.

Now these rights are facing a further set of challenges in the form of a proliferation of bilateral and regional Free Trade Agreements (FTAs) that circumvent the original TRIPS regulations and often impose TRIPS-Plus obligations, which require stricter IP and patent protection on countries. Countries on the receiving end of TRIPS-Plus obligations are consistently less able and apt to negotiate for better terms. Asserts Michelle Childs Director of Policy and Advocacy for Médecins Sans Frontières’ campaign for access to essential medicines,

Europe is using the fact that few people understand the technicalities of TRIPS and the implications of data exclusivity to appear virtuous by claiming that they will abide by the Doha Declaration while at the same time tying India into an agreement that could make generics more expensive and delay their access to people in the developing world who need them.⁽⁷⁾

The impact of this turn of events on access to ARVs in Africa is further compounded by generic producer India’s gear-shift: once exempt from TRIPS strictures (under provisions excusing developing countries who applied for it from compliance though 2005) it is increasingly interested in protecting its own burgeoning innovation. India’s sights are on more lucrative markets and it is aligning itself and its intellectual property legislation with TRIPS-Plus. This is set to be enshrined in a pending FTA between the European Union (EU) and India focused on data exclusivity.

Proposed new drug deals: the EU-India FTA

The proposed EU-India FTA is shrouded in secrecy, but seems to rest primarily upon an increasingly mutual interest to shore up data exclusivity provisions and IP safeguards to vouchsafe both European and Indian public (government-sponsored) and private (business) investments in innovation. As seen briefly above, the EU’s case for protection of intellectual property rights has its precedent in TRIPS and TRIPS-Plus, though this bilateral agreement would reach beyond what is enshrined in that multilateral legislation.

On the one hand, the EU’s push for enhanced protection of data exclusivity is warranted and could even prove beneficial: by ensuring the continuation of research and development into new and better drugs (as is the example in this case) and by preserving the bio-equivalence of generics (though the necessity of this is disputed below).

On the other hand, however, there is little evidence that research and development per se are harmed by the presence of generics or stymied by less vigorous intellectual property protections. Furthermore, little research and development is being invested into acute, infectious diseases that primarily affect the developing world (notably still HIV, TB and Malaria, as well as a host of infectious water-borne diseases) whose treatment would be severely compromised by such a successful FTA.

As such, what does appear certain is that a successful agreement between the two could severely hamper African access to generic ARVs which are the lifeblood of the continents’ drug-based efforts to combat the HIV & AIDS pandemic. According to Childs, quoted above, the EU-India FTA would enshrine data exclusivity to the point of requiring generic drug producers to “conduct their own clinical trials,” despite the inherent redundancy, delay and questionable ethics of such a requisite.⁽⁸⁾

MSF purchases 80% of its ARVs from India, and a full 92% of patients in low- and middle-income countries, most of them in Africa, rely on such generics to treat their infection. Consequently, the proposed FTA between the EU and India, designed to secure data exclusivity and IP rights, “will have a devastating public health impact around the world and adversely affect the right to health of millions of patients,”⁽⁹⁾ because in addition to the stipulations on data exclusivity and IP rights, “future scale-up using newly recommended ARVs will likely be hampered until Indian generic producers can provide the dramatic price reductions and improved formulations observed in the past.”⁽¹⁰⁾

The implications are even more dire when taking into account the increased evidence of viral resistance to cheaper first-line ARV drug therapies and the corresponding need for second- and eventually third-line drugs. As James Kamau, head of the Kenya Treatment Access Movement, notes, stricter data exclusivity and IP provisions as entailed in the EU-India FTA, “this marriage of convenience would also result in death for many Africans, particularly those who need newer, second-line drugs that may now take years to reach them.”⁽¹¹⁾

The EU has asserted that TRIPS protects drug access for the poorest and most vulnerable, that – “The [European] Commission explicitly recognizes India’s right to issue compulsory licenses for life-saving medicines,”⁽¹²⁾ e.g. it protects India’s interests and incentives to commit to the FTA - but as evidenced above, this has hardly been the case in practice, particularly in Africa. So what about Africa? And HIV & AIDS?

African opportunities

As far-fetched as it may sound, Africa, African Governments, and African citizens, do have a chance to secure benefits from the trend towards threatened further disenfranchisement illustrated by the FTA, such as the one outlined and criticized above. Their chance lies in the fact, stated at the outset, that more African Governments are assuming a more active role in financing and dictating the terms of their trade – including life-saving medications.

One method of action is contained in the increasing share of national budgets being allocated to fighting HIV & AIDS and to address health generally. Governments and national actors are thus more able to dictate the terms of their spending – and to take it elsewhere, including to invest in producing their own ARVs and other drugs, to shoring up their health systems and to retaining their (often well-trained) staff with incentive programmes and improved working conditions.

Another is the partnership framework agreements being implemented by PEPFAR and signed at this stage by Malawi and South Africa. These stipulate increased country ownership in the preparation and implementation of anti-HIV strategies, and might well serve as breeding grounds for teaching policy makers the ropes of (tangled) international negotiations. Given that lives are at stake on the African side, the incentives should be high.

A third is the increasing regional effort, in Mozambique, collaborating with Brazil (whom, it should be remembered, successfully invoked compulsory licenses), in Uganda and in South Africa, to produce generic ARVs for local and regional distribution. As Roemer-Mahler argues, an alternative source of production could be found in small companies in developing countries – companies that have an incentive to develop and manufacture drugs for local consumption, and who cannot afford to target larger, extra-regional markets.⁽¹³⁾

Just this is happening. “In 2007, for instance, Uganda commissioned a facility to produce generic ARVs locally in Uganda based on a joint-venture with Cipla, an Indian generic producer,”⁽¹⁴⁾ and has gained World Health Organisation (WHO) approval for its manufacturing process and is awaiting certification of its drugs. It is not alone: “some other African countries – Ghana, Tanzania, and Ethiopia - have started exploring the feasibility of local production of generic ARV drugs along the lines of the Uganda-Cipla venture.”⁽¹⁵⁾

Finally, despite the confounding circumstances, Africa and Africans are not alone in their struggle to fight the HIV & AIDS pandemic and also to confront potentially debilitating FTAs. Despite the constraining agreements and contending trends outlined above, Indian manufacturers have just announced their intention to produce generic versions of second-line ARVs.⁽¹⁶⁾ This is good news indeed.

Conclusion and recommendations

So while access to ARVs remain an issue of life or death for millions of Africans, and is one far from being resolved or even on a straight-forward path towards any such resolution, there is scope for both steely-eyed debate and yet also room for hope. One option is for developing and emerging countries – and their economies and economic niches – to increase their cooperation; as through South-South and BRIC relations. A related benefit of such collaboration is that as a result of parallel efforts, in and beyond the scope of health-related intellectual property negotiations, these countries “may be able to not only reduce the ongoing push by the European Communities and the United States to ratchet up global intellectual property standards,” but be able to “enlarge the policy space that can be used to develop their intellectual property, trade, and public health policies.”⁽¹⁷⁾

Finally, there should be a way for both intellectual property rights’ to take their place beside the right to life; a forged balance between increasingly equal power blocks – by the ‘West’ of the US and EU, the East, and in India, or of the South, as in the increasingly assertive South-South alliances. Thus as indicated in the above discussion, the ball is not permanently in the court of the powerful of today. African and other southern countries are increasingly (re)asserting their voices and their rights, and those of their citizens, to, among other things, provide access to essential medicines to fight HIV & AIDS, scoping out and creating new spaces to guarantee access. It is a long journey replete with setbacks; but it is not over yet – and need not be a zero-sum game.

NOTES:

(1) Contact Annamarie Šehović through Consultancy Africa Intelligence’s HIV & AIDS Unit (annamarie.sehovic@consultancyafrica.com).
(2) Coupled with increased funding from Global Fund to Fight HIV, Tuberculosis (TB) and Malaria, UNAIDS and private donors such as the Gates and Clinton Foundations.
(3) See Roemer-Mahler, A., 2010. Business Strategy and Access to Medicines in Developing Countries. Global Health Governance, IV (1). For more details about the right to invoke TRIPS provisions visit http://www.ghgj.org.
(4) Quoted in Aginam, O., 2010. Global Health Governance, Intellectual Property and Access to Essential Medicines: Opportunities and Impediments for South-South Cooperation. Global Health Governance, 4 (1), http://ghgj.org.
(5) Ibid.
(6) Ibid.
(7) Plus News IRIN, ’EU-India deal could threaten access to essential HIV drugs’, 9 November 2010, http://www.irinnews.org.
(8) Ibid.
(9) MSF, ‘UN Special Rapporteur Anand Grover on EU-India FTA's threat to generic medicines’, 10 December 2010, http://www.msf.org.
(10) Waning, B., et al. 2010. A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries. Journal of the International AIDS Society, http://www.jiasociety.org.
(11) Plus News IRIN, ’EU-India deal could threaten access to essential HIV drugs’, 9 November 2010, http://www.irinnews.org.
(12) Ibid.
(13) See Roemer-Mahler, A., 2010. Business Strategy and Access to Medicines in Developing Countries. Global Health Governance, IV (1). For more details about the right to invoke TRIPS provisions visit http://www.ghgj.org.
(14) Quoted in Aginam, O., 2010. Global Health Governance, Intellectual Property and Access to Essential Medicines: Opportunities and Impediments for South-South Cooperation. Global Health Governance, 4 (1), http://ghgj.org.
(15) Ibid.
(16) US Council on Foreign Relations Global Health Update 10 January 2011.
(17) Yu, P.K., 2008. Access to Medicines, BRICS Alliances, and Collective Action. American Journal of Law and Medicine, 34, pp.345-394. as quoted in Aginam, O., 2010. Global Health Governance, Intellectual Property and Access to Essential Medicines: Opportunities and Impediments for South-South Cooperation. Global Health Governance, 4 (1), http://ghgj.org.

Written by Annamarie Bindenagel Šehović ⁽¹⁾