he year 2020 having been largely disrupted by the Covid–19 pandemic, the news and prospects of getting a vaccine could be the best thing 2021 could offer.
As the world welcomes the vaccine, the media have reported that the available doses have been pre-purchased by richer countries. This is not the first time the world is in such a place of combating a public health crisis.
When several countries agreed to be signatories to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) in 1994, patentability of pharmaceutical products was approved and this meant that pharmaceutical companies had the monopoly to determine the prices of medicines. This would in turn diminish the ability of most developing countries in accessing drugs.
At the time, the world was battling the HIV/AIDS epidemic and this meant that the impact of the epidemic would escalate especially in poor countries which could not access the medicines.
Although Article 31 of the TRIPS Agreement assigned governments an avenue of compulsory licensing for purposes of remedying anti-competitive practices, cases of emergency, government use, public interest grounds and in instances of insufficiency of working of an invention; most countries that tried to invoke these flexibilities faced resistance from pharmaceutical companies.
This explains why in 1998 over 39 pharmaceutical companies instituted a case against the government of South Africa after enacting a new patent law that permitted it to use both parallel importation and compulsory licensing during the surge of the HIV/AIDS epidemic in the country.
However, the pharmaceutical companies withdrew their case in 2001 after pressure from civil society organizations globally.
Such developments influenced the international debate that saw developing countries seeking a declaration from the World Trade Organisation Ministerial Conference in Doha (9th – 14th November 2001) on grounds that the TRIPS Agreement should not prevent members from adopting measures necessary to ensure access to medicines hence the birth of the Doha Declaration.
On 6th December 2005, the TRIPS Council adopted the Protocol amending the TRIPS Agreement by inserting Article 31. The amendment made it possible for countries to export medicines under compulsory license to countries with no or insufficient manufacturing capacity.
The amendment also allowed members to issue compulsory licenses for the production and export of pharmaceuticals to an eligible importing member. The amendment took effect on 23rdJanuary 2017.
As much as there have been such progressive developments in the international legal regime, the realities and challenges faced by poor countries continue to soar and the emergence of Covid–19 presents new challenges.
On 14th December, 2020 the East African newspaper reported that majority of the East African citizens will have to wait until 2022 to access the Covid–19 vaccine and that the region would have to be a beneficiary of the GAVI vaccine initiative, co-led by the World Health Organisation.
And on 9th December 2020, I the Ministry of Health of Uganda tweeted that it had submitted a COVAX application on 7th December 2020 under the GAVI COVAX facility where it hopes to access 9 million doses of the vaccine to cover 20% of the population. The mere fact that poor countries are not applying directly to the manufacturers says a lot as to how the intellectual property regime continues to hamper access to medicines in poor countries.
The efforts by governments of the poor countries to access the vaccine through the COVAX application is also subject to the production capacity of the few intellectual property holding manufacturers. This therefore means that COVAX also competes with the developed countries to secure supply from the few manufacturers. Due to funding gaps, it is estimated that COVAX has reserved approximately 700 million doses while countries included on the COVAX advance market commitment represent over 3 billion people.
The irony is that the European Union intends to reserve over 1.5 billion Covid–19 doses for a population of fewer than 450 million people.
The TRIPS flexibilities that would be complementary to national intellectual property legal regimes of poor countries continue to be undermined by developed countries like the United States, Japan, and European Union with the aim of protecting their pharmaceutical industries. Such a status quo makes it impractical to exercise the TRIPS flexibilities.
This explains why India and South Africa submitted a proposal to the World Trade Organisation requesting the members to waive their intellectual property rights: copyright, industrial designs, and patents until the global population receives effective vaccines to Covid- 19.
The proposal however has been opposed by most developed countries like the Unites States, United Kingdom, and Norway arguing that the existence of such an intellectual property system fosters innovation and incentivizes new inventions of vaccines.
Uganda’s Industrial Property Act 2014 recognizes the use of compulsory license and other flexibilities provided for under the TRIPS Agreement. The Act is to the effect that the rights under the patent do not extend to acts in respect of articles which have been put on the market in Uganda or in any other country or imported into Uganda by the owner of the patent or with his or her consent.
Therefore, once a product has been sold with the consent of the patent holder, the rights of commercial exploitation over this product can no longer be exercised by the owner since they are exhausted. Therefore, subsequent acts of resale or other forms of commercial use can no longer be opposed or controlled by the patent holder. Hence parallel imports anywhere in the world may no longer be opposed based on Intellectual Property rights because of the concept of international exhaustion.
In such a case the patent holder no longer has the monopoly to set the prices of drugs. The prices would be definitely lowered to enable access to developing counties and least developed counties like Uganda.
However, efforts made by countries like Uganda to benefit from her legal regime and complement it with the international instruments are frustrated by the developed countries which seek to protect their pharmaceutical companies at the expense of preserving lives.
The world is facing a pandemic and there is no better time for the world to unite than today.
Stay Safe and always put on your mask.