Patents Could Impact Negatively on Zim’s Access to COVID-19 Treatment

DOZENS of coronavirus vaccines are currently under development as the world races towards getting a vaccine that could rescue the world from the prevailing misery. To date, more than 150 coronavirus vaccines are in development across the world—and hopes are high to bring one to market in record time to ease the global crisis.

By Michael Gwarisa

The World Health Organization is also coordinating global efforts to develop a vaccine, with an eye toward delivering two billion doses by the end of 2021. However, in the midst of all these positive developments, the issue of  cost and access to the vaccine remains a key factor considering that the coronavirus is a global pandemic that has spread to almost each and every part of the world including poorly resourced countries.

According to a communique issued following the ‘Africa’s Leadership Role in COVID-19 Vaccine Development and Access’ conference of the African Union (AU), African health ministers took a crucial step to state their concern that patents and other technology barriers could negatively impact the ability to ensure access of future potential COVID-19 vaccines in developing countries.

This acknowledgement stands in stark contrast to the misconception commonly expressed by pharmaceutical corporations and some public health actors that intellectual property does not play a major role in restricting access to vaccines. Not only does the AU make this important point, but it also emphasizes that governments should urgently make use of legal and policy options to eliminate intellectual property barriers, as needed, in the interest of public health.

Past experience including with the pneumococcal vaccine and human papillomavirus vaccine—has shown that patents  can affect every step of vaccine development, and monopolies can hinder timely introduction of affordable vaccines in developing countries. Sufficient and timely supply of any COVID-19 vaccine will require a broad manufacturer base, which must be supported by opening access to all necessary technology, intellectual property and data with full rights to use, manufacture and supply globally.

For a country like Zimbabwe whose health sector and economy are in the doldrums, access to vaccines and COVID-19 medicines could be a toll order owing to tight restrictions patents come with. According Simbarashe Makahamadze an Intellectual Property Rights Consultant at Palladium IP Consultants, patents on pharmaceutical products including COVID-19 vaccines could hit hard on developing countries which lack the capabilities to manufacture their own medicines, Zimbabwe included.

The general issue is that the purpose of the patent law is to promote innovation and in such a sense, when someone gets a patent, they get 20 years to utilise or commercialise that patent before it goes into the public domain and that same law applies to pharmaceutical patents, they will be protected for those 20 years where the owner of the patent or the owner of that pharmaceutical product has got time to commercialise and get money out of that patent because there is a lot of investment and research that would have been invested to get to the patent level.

“Then there is the issue of COVID-19 which is a crisis and if you look at the developing countries, most of them are not equipped and don’t have the capability to actually manufacture their own pharmaceutical products. What normally happens is that if you look at patents or what is called patent landscaping, you find that most of the patents might actually not be protected in the developing countries because its either not a market of interests for that patent but for all the pharmaceutical products that come to Africa and the developing world, you see that the pharmaceutical companies do have existing and valid patents in those countries and jurisdictions,” Mr Makahamadze.

He added that there is an initiative that was started by one of the developing countries where the countries are having the COVID-19 intellectual property pool and the World Health Organisation (WHO) is also involved. The initiative seeks to mobilise resources to help in the fight against the pandemic.

“There is also a legal option that can be used to utilise patent protected COVID-19 possible solutions and medications. In this case, from a developing world point of view, there is a flexibility that was introduced by the World Trade Organisation (WTO) under the trade related aspects of the Intellectual Property Rights (IPR) which is commonly known as the TRIPS agreement.

“The compulsory license which also part of the Zimbabwe Patent Act allows either the production of drugs under certain circumstances or the importation of patent protected drugs from other countries if the importing country for example Zimbabwe lacks the pharmaceutical or industrial infrastructure that is necessary to manufacture these pharmaceuticals. The compulsory licensing can actually be done without the patent holder’s consent.”

He however added that there are certain conditions that need to be met for the compulsory licence to be effected so that the drugs even if they are patented, they can actually be manufactured and utilised especially in the face of a crisis like COVID-19 which most countries have classified a calamity.

“Whether the rights holder or the patent holder were not to grant their consent to allow countries to manufacture, it is still possible to then proceed and impose a compulsory licence over severe health challenges like the COVID-19. The government should however be in a position and willing to pay a reasonable fee to the holders of the patents.

“There are also other medications which are already in existence, a combination of those which can also be use to treat or at least control COVID-19. The concept still applies that  those medications if they are going to be produced or if they are going to be mass produced, the easier option will be compulsory licensing where they have to just manufacture or import for the purposes of dealing with a health crisis,” said Mr Makahamadze.

Under the compulsory licensing, the government has to issue a Statutory Instrument (SI) or a legal instrument allowing the manufacturing or importing of a patent protected pharmaceutical product for the purpose of dealing with a health crisis and there should be conditions that need to be met for an issue to be regarded as a national crisis which requires the introduction of compulsory licencing.

“The problem however is that, even if Zimbabwe is granted the licence to manufacture COVID-19 related drugs, is the country able to manufacture. I doubt so, the only option will then be to import which is called parallel importation.

“For example, the 2002 compulsory licence that was issued by the Ministry of Justice when they declared a state of emergency for HIV and AIDS. The compulsory licence was meant to enable the government to make use of any patented drugs including Antiretroviral (ARVs) medications to treat HIV and related conditions and this compulsory licence was actually issued to Varichem. This compulsory license for Zimbabwe however was not really successful I don’t think even Varichem even managed to manufacture the related drugs and ARVs.”

According to Candice Sehoma, Access Campaign Advocacy Officer with MSF in South Africa, there is need for African leaders to take a leading role in advocating for the relaxation around access to medications especially in the face of COVID-19.

“It is extremely encouraging to see African leaders state so clearly that they know the impact patents and other forms of intellectual property could have on access to a potential future COVID-19 vaccine in their countries. We are enthusiastic about the leadership demonstrated in this communique, not least the leadership that Africa CDC has shown in driving an African response to the COVID-19 pandemic.

“For too long, there has been an outright denial of the fact that patents and other intellectual property hinder access to newer vaccines in developing countries. There is ongoing denial and ambiguity by several global health actors and industry around policy plans and messages with regard to intellectual property and technology transfer and their impact on ensuring access to a COVID-19 vaccine. Few promises have been made so far to ensure the full transfer of technologies for vaccine production in developing countries and concrete measures are yet to be put in place to remove intellectual property barriers,” said Sehoma.

She added that past experience has shown that patents can have a serious negative impact on the price and supply of newer vaccines for resource-limited countries, including in Africa  by restricting market entry for vaccine manufacturers in developing countries and delaying access.

“We can’t let history repeat itself and follow down the same path where we pretend patents aren’t a problem and instead overpay specific pharmaceutical corporations for expensive vaccines. The world really can’t afford any delays which could be caused by unjustified private control of any future COVID-19 vaccine.

“We hope to see African leaders put their own recommendations into action, by taking legal measures to ensure that intellectual property does not get in the way of their people’s timely access to any future COVID-19 vaccine.”

Take home messages from a recent  AU and African Health Minister meeting indicate that, for developing countries to benefit from the COVID-19 related medications,  countries should make full use of legal and policy measures, as the AU stresses. Pharmaceutical corporations with essential vaccine technologies should make these publicly available, and COVID-19 vaccine developers should openly share their data, know-how and technology to facilitate rapid scale-up at the global level.

The operative language in the AU communique reads as follows:

“RECOGNISE the barriers that intellectual property, including patents, trade secrets and other technological knowhow has posed to timely introduction of affordable vaccines in developing countries in the past.

“ACKNOWLEDGE this experience, noting that there is an urgent need for countries to make full use of legal and policy measures, including flexibilities enshrined under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and Doha Declaration, South-South and North-South collaboration to ensure monopolies do not stand in the way of access to COVID-19 vaccines.

“ALSO CALLS UPON, and in line with the recommendations of the 73rd World Health Assembly resolution on the COVID-19 response, for all countries to remove all obstacles, including, but not limited to, the use of the flexibilities provided in the TRIPS agreement, to ensure that all relevant technologies, intellectual property, data and knowhow are openly and immediately made available and the rapid scale-up of geographically diverse production to be made possible.”

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