India and South Africa have asked the World Trade Organisation to seek a waiver in some provisions in the International agreements of IP (Intellectual Property) rules to simplify the export procedures of medicines / vaccines by making it available to the general public and to prevent the hindrances in IP procedures in the regime of patent, trade secret, industrial design, copyright and protection of undisclosed information which may come in procedure of vaccine / medicines development and availability and other medical developments for Covid 19 which is the top priority of the hour.
Purpose is to make sure that apart from the developed nations no developing nations should be left behind in the race of vaccine nationalism race.
The proposal was presented jointly by India and South Africa at the WTO, an intergovernmental body overseeing international trade, on 2 October. The matter is expected to be taken up for discussion at a meeting of the TRIPS Council, which administers the agreement, on 15-16 October.
According to the government, there should be major waiver until the world develops immunity and vaccine or medicines are available globally without any discrimination or legal national or international laws.
“Internationally, there is an urgent call for global solidarity, and the unhindered global sharing of technology and know-how in order that rapid responses for the handling of COVID-19 can be put in place on a real time basis,” the letter says. It asks that the council urgently approach the WTO’s high-level decision-making body, the General Council.
WAIVER in IPR –
It is a special use of Compulsory license for export of medicines to those countries that has an insufficient production capacity keeping in mind the urgency of the medical situation. That is TRIPS Article 31 bis. In the matter of India and a South Africa the problem is there is no generic source of this Covid drug globally and majorly in sufficient production capacity estimated by their national governments by assessing on-going all situations like manpower and resource security. Waiver seems to be the appropriate solution as of now. Even if authorities grant compulsory license the problem of insufficient production capacity arises therefore export of the drugs is the solution as of now till the time country is capable of making its own drugs.
Background of the TRIPS Waiver Agreement –
The TRIPS agreement originally put down significant hurdles for the effective use of compulsory licensing for the supply of medicines to countries without sufficient medicines production capacity. This was because article 31(f) of TRIPS restricted compulsory licensing too predominantly for the supply of the domestic market.
In other words, issuing a compulsory license to produce medicines mostly for export was not compliant with TRIPS. As a result countries that relied on importation to give effect to a compulsory license were at a disadvantage compared to those with production capacity.
This problem was recognized in 2001 by the Doha WTO ministerial conference that took a decision to find an “expeditious solution” to the problem. This became known as the Paragraph 6 mechanism after the section of the Doha declaration that addressed the issue.
Since 30 August 2003, a waiver to Article 31(f) has been in place that allows WTO Members to issue compulsory licenses specifically for export to address needs notified by other countries under the system.
The waiver formed the basis for a permanent amendment of the TRIPS Agreement (Article 31bis) which came into force on 23 January 2017 and replaces the waiver.
TRIPS Article 31bis does not need to be invoked in case a compulsory license is needed to import sources of generic medicines that are already available on the international market.
While in principle the system is available for all WTO Members, in 2003 some high-income countries opted out of the mechanism as importers. These countries are: Australia, Canada, the European Communities (with its member states), Iceland, Japan, New Zealand, Norway, Switzerland, and the United States.
Note: however, that countries that have chosen to opt out of the use of the TRIPS 31bis mechanism as an importer can still use compulsory licensing to allow importation of generic medicines that do not require a compulsory license in the country of production.
Various International Drug companies have said they have to protect data to fund and develop the Intellectual property in this sector which is very urgent to develop. Though lot of IP espionage, IP stolen trade secrets cases have been come up which also needs major protection. It is also a concern and this side should also be known. Therefore WHO (world health organization) has supported as of now a Covid 19 technology access pool where IP data can be shared voluntarily. Aptly no doubt there is a global demand of vaccines and medicines at a rapid speed. Many developed nation like Europe, United States, Britain, Germany have already placed major order and bets at millions of medicines and vaccines even without proper
completion of vaccines trials. Developing nation are not in a role to place such bets therefore for ethical reasons and for global harmony developing nations cannot be left behind as it’s not a one nation concern and everybody has to cooperate for deal with another country at some point of their life to run the economy.
In a country like India, Modi government has lauded the efforts and hard workers done by Indian medical experts and scientists in contributing their work and research studies in to the Covid vaccines and prevention of Covid 19 medicines by making other drugs and medicines which can indirectly at least calm Covid, which can’t be ignored completely in pharmaceutical capacity of India.
India in harmonious terms very recently exported and made an Anti-viral drug hydroxychloroquine (commonly known as HCQ) to some nations like US and Britain.
India is the world’s largest manufacturer of hydroxychloroquine. It recently banned exports saying the stocks were needed for Indians, but the government lifted the ban on Tuesday and said it would supply the drug to “nations badly affected by the coronavirus” and neighboring countries to help out during the pandemic.
These cooperating actions by Modi govt are appreciating to claim and present their points and opinions at General Assembly of UN for demand of Waiver. Other countries should definitely take this into consideration however India claims to the largest producer of this drug but there are some loopholes like there has been reported to be shortages of this drugs in Indian stores .
Arguments have been presented by the countries in joint submission in a council for Trade related aspects of intellectual property rights ( TRIPS ) that some countries specifically developing nations whose affecting rate is very disproportionate would find it very difficult to cope up to this pandemic to access the vaccines and medicines quickly.
Leena Menghaney, who heads the access campaign in South Asia for international aid group Doctors without Borders, called it “crucial that other member governments of the WTO support this, as we need to ensure that vaccines, drugs and other medical tools needed for COVID-19 can be scaled up by countries and their manufacturers without facing protracted negotiations for licenses.”
Africa’s 54 countries have teamed up during the COVID-19 pandemic to pursue equitable access to any effective vaccine. An African Union communiqué in June said governments around the world should “remove all obstacles” to any vaccine’s swift and equitable distribution, including by making all intellectual property and technologies immediately available.
The communiqué specifically mentioned the Doha Declaration on public health by WTO members in 2001, which refers to the right to grant compulsory licenses – where a government can license the use of a patented invention without the consent of the patent-holder.