Role of Security Exception in the Unprecedented COVID-19 Pandemic
The unprecedented COVID-19 pandemic has challenged the healthcare sectors all
over the world. A sudden scale up in the production of PPE kits, COVID testing
kits, medicines, masks, scanners and ventilators was the need of the hour. After
the innovation of vaccines, their production and exportation worldwide became
the following critical need. The extreme sufferers of this adversity were the
third world countries.
The reason being one, the lack of infrastructure and the
inability to produce in such huge numbers. Second, the intellectual rights of
the owners on these production technologies or the product itself. The owners
have the sole right to determine. The invention carries several primary and
secondary rights around it, making it further challenging to invent something
without infringing the IPR. As said, the third world countries were stuck from
Keeping such a situation in mind, in 1995 the WTO members in the
eighth round of GATT negotiations adopted the Agreement on Trade-Related Aspect
of Intellectual Property Rights (TRIPS), which comes up with flexible measures
which include a grant of compulsory license, invocation of security exceptions,
parallel importation, use of transitional waivers for the less developed
countries and ensuring the fair procedure while enforcing IPR.
Article 73(b)(iii) of the TRIPS agreement, which talks about security
exceptions, which states that a member state is not prohibited from taking steps
necessary to protect essential security interests, taken in the time of war or
other emergencies in international relations. The members may invoke this
provision to suspend the IP rights on the innovation. This will facilitate
domestic production if the country is capable of or ease the importing of such
The question arises whether the COVID-19 pandemic forms an "emergency in international relations?" To answer this, we need to refer to the para
5(c) Doha Declaration, which includes "public health crisis and epidemic",
as a national emergency. Thus, the invocation of Article 73(b)(iii) in a far
concerning situation like a COVID-19 pandemic is valid. Moreover, a WHO declared
global pandemic constitutes an international emergency.
Another question that arises is how effective is the invocation of Article
73(b)(iii) of the TRIPS Agreement?
Taking into view the production of vaccines, medicines and pharmaceuticals
carrying heavy patents, the countries benefited by invocation of Art 73(b)(iii)
would only be the countries with excellent production capacity.
security exceptions and justify the suspension of the patent rights in order to
protect their national security interests. By doing so, they can start producing
the product in their own country without violating the holder's patent rights.
But what happens to the countries with poor manufacturing capacity?
Coming to the importation aspect of vaccines, medicines and pharmaceuticals, we
can maybe say that the country "C" with poor manufacturing capacity can import
these products from country "B", which is producing in mass by way of compulsory licencing. The problem arises when Article 31(f) of TRIPS comes into the
Article 31 talks about Compulsory licencing and the grounds to be
followed on its issuance. It is a licence granted by the government of a state
allowing another party to use the product without the patent holder's consent.
Article 31(f) puts a limitation saying that after a compulsory licencing grant,
the producing country shall only use the product for supply in its domestic
market. Such a condition puts underdeveloped or developing countries at peril
To overcome such an issue in 2003, the General Council of WTO adopted
paragraph six of the Doha Declaration on TRIPS and Public Health, in the form of
Article 31bis. It starts with defining what pharmaceutical products are, which
country is eligible to import and who is an exporting country.
It goes on to
provide a procedure laid down for such importation. The fundamental requirement
is that the country needs to establish that it is a country with poor or no
production capacity. Thereby, it waives the obligation under Article 31(f),
thereby letting the country with poor manufacturing capacity import a particular
pharmaceutical product from the country producing under the compulsory licencing
grant. Such importation does not violate any provisions under the agreement.
Hence, invocation of security exceptions can only be beneficial to countries
with good production capacity. As far as the underdeveloped countries are
considered Article 31bis is the provision that comes to the rescue.
Law Article in India
You May Like
Legal Question & Answers