A patent is filed for the COVID-19 vaccine...what now?
Various countries across the globe are in a race against time to develop the first vaccine for COVID-19. While Russia has reported a possible vaccine for the virus, some scientists have argued that they have cut several corners to release their vaccine, which raises some concerns regarding its safety.
The process of developing a pharmaceutical composition that is safe for human consumption could very easily cost millions and take a significant amount of time, as it requires several compounds to be tested, of which only a small number are viable for human testing.
The human candidates are subjected to controlled testing or human trials to determine firstly whether the compound is effective and, secondly, whether there are any side-effects.
As one can only imagine, these companies will want to recoup some of their costs in some shape or form. This is often achieved by registering their intellectual property rights in the form of a patent. If the patent is granted, the company will obtain a limited-term monopoly over their pharmaceutical in the marketplace to help recover the costs of research and development.
The prospect of one company obtaining a monopoly over the eventual COVID-19 vaccine has undoubtedly raised some concerns, as various pharmaceutical companies are accused of charging exorbitant prices for some life-saving medications.
For example, the former American hedge fund manager, Martik Shkreli, rose to infamy when he raised the price of the pyrimethamine drug used to treat parasite diseases, toxoplasmosis and cystoisosporiasis (commonly referred to as “Daraprim”) from $13.50 to $750 overnight. Shkreli argued that the increase was required to increase funds used to develop improved drug compounds, but the move was revealed to be nothing more than a cash-grab.
The big question therefore is, how will the pricing of a COVID-19 vaccine be controlled if one company has obtained a monopoly over it? More importantly, how will it be priced in South Africa?
Some foreign jurisdictions have measures put in place to deal with such a situation. The United States of America has the Bayh-Dole Act 1980 which empowers the American government to use patents that result from federally supported research. In addition, the Act also provides that the government can be granted a free license to use the patent or, alternatively, put measures in place for a third party to use the patent on its behalf.
The system is somewhat similar in South Africa, but with some important differences. Section 56 of the Patents Act provides for the possibility that a compulsory license be granted where the patent is not being worked in South Africa to an adequate extent, as well as where the price of importing the patented pharmaceutical is excessive.
In addition, South Africa’s Medicines and Related Substances Control Act (the Medicines Act) and Medicines and Medical Devices Regulatory Act (SAMMDRA) also have provisions for granting compulsory licences in respect of drug patents.
The Medicines Act has strict guidelines directed to the pricing of medicines by the manufacturer, distributor/wholesaler, and the licensed retailer. These measures have been put in place to allow the Minister of Health to make affordable medication available to protect public health, which was well exemplified by South Africa’s response to the AIDS crisis; resulting in South Africa having the world’s largest antiretroviral treatment (ART) programmes to make these drugs readily available to the South African market.
In conclusion, South Africa like many countries around the world, has the necessary legislative measures in place to consider making vaccines and other medicines affordable and even freely available to the general public, and the public and private health sectors are committed to giving patients the treatment they need. The AIDS crisis, like other health crises that came before it, has taught our health sector a great deal as to how to respond to those challenges we now face with the COVID-19 pandemic, and the foreseeable future.