The time for procrastination over patents is over

The path to patent law reform in South Africa has been long and arduous. But the need for finalisation of legislation is now even more urgent given the Covid-19 pandemic and the expected rush to the patent office for monopolies on new and repurposed medicines, diagnostics, medical devices, and other vital health products, including personal protective equipment.

Although the government finally issued its progressive IP Policy Phase 1 in 2018, this followed a seven-year campaign by civil society to end the stranglehold of pharmaceutical patents on access to medicines. The campaign demanded substantive examination of patent applications on medicines, tightening patent eligibility requirements, and making use of lawful flexibilities under international law to bypass or override patent rights when necessary to protect public health and access to medicines for all.

The Fix the Patent Laws Campaign, by now a coalition of over 40 patient and advocacy groups, was launched in 2011 by the Treatment Action Campaign, SECTION27, and Doctors Without Borders to advocate for such reforms, all lawfully permitted under the World Trade Organisation Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). After a long-delayed false start with a poorly drafted proposed policy, the then Department of Trade and Industry developed an excellent policy proposal in 2018 articulating and justifying the need for the pro-public health reforms. This policy was then adopted by Cabinet.

Now, almost two long years later, people in South Africa still await the needed legislative changes that will operationalise the government’s declared and thoroughly vetted policy outline.  Even then, the legislation will need to be released for public comment – what we hope will be an expedited and compact process. The proposed legislation was intended to be released by March or April this year, but now the urgency is even more evident.

The Covid-19 pandemic has inspired an unprecedented global effort to research, develop, and obtain regulatory approval for vitally needed diagnostic tests, medicines, vaccines, medical devices and other health products. However, at the same time that researchers are working overtime in laboratories and sharing their research in a gratifying turn to open science, pharmaceutical companies and medical devices companies are racing to patent offices around the world to secure monopoly protections on products developed with substantial public funding.

South Africa remains uniquely vulnerable to this rush to patenting because it readily grants patents with no substantive examination as to their merits, and at rates of approval far in excess of even the United States and Europe, let alone other middle-income countries facing similar health threats. This system of examination on mere formalities results in an unending stream of secondary “evergreening” patents on new uses, formulations, dosages, variations, and combinations of known medicines which lengthen the monopolies on them without adding significant therapeutic benefits.

Many of the Covid-19 investigational medicines and vaccines currently under review build on previously patented inventions, with the result that the newly granted 20-year patent monopolies will likely erect a huge affordability barrier to the kind of emergency response needed to face down the Covid-19 threat.  To defeat this pandemic, South Africa will need to overcome existing patent, trade secret, and other access barriers, and prevent unworthy patents on new Covid-19 uses of known medicines and medical technologies and supplies.

This is an emergency. Not only must South Africa immediately release its draft legislation to amend the Patents Act No 57 of 1978, but it must also adopt and enforce a short timeframe for comment and deliberation.

The South African government declared a national state of disaster on 15 March 2020 and subsequently issued a number of regulations to give effect to that declaration. Among these are regulations exempting the banking sector from applying certain provisions of the Competition Act No 89 of 1998.

We propose that in the context of the current crisis, the Minister of Trade, Industry and Competition considers appropriate regulations in respect of patented, and pending applications, for medical products and, further, uses his authority in terms of section 4 of the Patents Act to utilise any relevant patented inventions for public purposes.

Parliament should also consider adopting emergency measures in respect of medical products commensurate with the threat posed by Covid-19. Parliament should adopt emergency legislation patterned on that proposed in its BRICS partner, Brazil, that would grant automatic compulsory licences on Covid-19-related medicines and medical products so that the country can immediately secure alternative and cheaper sources of supply, including by mobilising its own domestic manufacturing capacity.  

However, South Africa should go a step further by requiring compulsory access, if needed, to originators’ clinical trial data, trade-secret-protected know-how, and other data and exclusive rights needed to fast-track emergency sources of supply.

These approaches will have the added benefit of both utilising and enhancing local pharmaceutical manufacturing capacity in South Africa and on the continent. Already, under the auspices of the African Union Development Agency (AUDA-NEPAD), the African Pharma Conference has convened a meeting of stakeholders on a possible continental Covid-19 response in order to assure and sustain supply lines. They include: the African Centre for Disease Control and Prevention, African Society for Laboratory Medicine, Federation of African Pharmaceutical Manufacturers Association, African Development Bank, WHO-AFRO and others.

In a world where rich countries are rushing to the front of the queue to outbid countries in the global south, and to stockpile scarce medical supplies, South Africa and other African countries must act urgently to overcome and prevent monopoly protections on vital life-saving medicines, diagnostics, vaccines, and devices.

Unless timely action is taken, South Africa could be faced with a new form of “pharmaceutical apartheid” like that experienced in the early days of the AIDS response, when access to medicines here was blocked by decisions made by rich countries and pharmaceutical companies in the global north.  

It is time to act urgently. The time for procrastination is over. DM/MC

Professors Vawda and Baker are Honorary Research Fellows, School of Law, University of KwaZulu-Natal.