   
  
IP/C/W/680  
 
4 June  2021 
(21-4600) Page: 1/3 
Council for Trade -Related Aspects of  
Intellectual Property Rights  Original: English  
 
  
URGENT TRADE POLICY RESPONSES TO THE COVID -19 CRISIS: INTELLECTUAL 
PROPERTY  
COMMUNICATION FROM THE EUROPEAN UNION TO THE COUNCIL FOR TRIPS  
1.  The COVID -19 pandemic continues to be a global health and economic crisis affecting all 
WTO Members. Concerted global efforts are required to ensure that all people in all countries have 
access to safe and effective COVID -19 vaccines and therapeutics as soon as possible. The WTO must 
step up its efforts to ensure that the rules -based global tradi ng system plays its role in response to 
the crisis.  
2.  On 4 June the European Union submitted to the WTO General Council a Communication on 
"Urgent trade policy responses to the COVID -19 crisis". The Communication underlines that the EU 
strongly supports a m ultilateral and comprehensive response to the COVID -19 pandemic. The most 
urgent challenge now is to ensure a rapid and equitable roll out of vaccines and therapeutics globally, 
as this is the only way to control the virus effectively.  
3.  The Communication un derlines that the rules -based global trading system can contribute to 
expanding the production of and equitable access to COVID -19 vaccines and therapeutics swiftly. 
Since last year, together with a growing number of WTO Members , the EU has been calling fo r a 
multilateral Trade and Health initiative. The EU has also been engaged in discussions on the proposal 
for a temporary waiver of intellectual property rights for COVID -19 health products, and has strongly 
supported the WTO 's Director General in her init iative to consider practical ways to enhance 
production capacity and cooperation with the private sector.  
4.  The EU proposes that WTO Members  agree as soon as possible on a global trade initiative for 
equitable access to COVID -19 vaccines and therapeutics en compassing the following three 
components: 1) trade facilitation and disciplines on export restrictions; 2) expansion of production, 
including through pledges by vaccine producers and developers and; 3) clarification and facilitation 
of TRIPS Agreement fle xibilities relating to compulsory licences.  
5.  While the EU considers that the General Council should be the forum to address all three 
components in a comprehensive manner, the third component on intellectual property is in the remit 
of the Council for TRIP S. For this reason, the EU is presenting the specific elements related to 
intellectual property to the Council for TRIPS.  
6.  The rapid development of several safe and effective COVID -19 vaccines has shown the value of 
intellectual property, in terms of the n ecessary incentives and rewards to research and innovation. 
With the support of public financing, pharmaceutical and biotechnology companies throughout the 
globe have built on their expertise and invested resources to find solutions against COVID -19. With 
several successful vaccines available, research into alternative vaccines and new treatments against 
COVID -19 continues. In that context, the role of intellectual property will continue to be essential. 
However, the role of intellectual property is not lim ited to incentivising the development of vaccines 
and treatments. Intellectual property should also play an important role in enabling equitable access 
to COVID -19 vaccines and therapeutics.  IP/C/W/680  
 
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  7.  In less than a year, the global production of COVID -19 vaccines h as gone from 0 to 2 billion 
doses produced by end of May 2021. It is estimated that more than 10 billion doses of COVID -19 
vaccines will be produced by the end of 2021. However, the urgency of the public health crisis 
requires not only the acceleration of the production of vaccines but also their equitable global 
distribution.  
8.  The 2001 Doha Declaration on the TRIPS Agreement and Public Health clarifies the links between 
the TRIPS Agreement, its flexibilities and public health. It affirms that the TRIPS Agr eement does 
not and should not prevent Members from taking measures to protect public health. It further affirms 
the flexibilities contained in the TRIPS Agreement, including specific flexibilities related to 
compulsory licences. The Doha Declaration state s that each Member has the right to grant 
compulsory licences and the freedom to determine the grounds upon which such licences are 
granted. It also states that each Member has the right to determine what constitutes a national 
emergency or other circumsta nces of extreme urgency which includes public health crises.  Under 
paragraph 1 of Article 66 of the TRIPS Agreement and following further extensions of the period 
provided therein, the least developed country Members are exempted from the obligations under  
the TRIPS Agreement except Articles 3, 4 and 5 until July 2021. The extension of this period is 
currently under discussion by the Council for TRIPS. The least developed country Members are also 
specifically exempted from obligations under Sections 5 (Pate nts) and 7 (Protection of undisclosed 
information) of Part II of the TRIPS Agreement with respect to pharmaceutical products until 2033.  
9.  The discussions in the Council for TRIPS since the start of the COVID -19 pandemic have identified 
aspects related to th e use of compulsory licensing that, in the view of a number of WTO Members, 
limit the use of this tool. In order to address these aspects, provide more legal certainty and enhance 
the effectiveness of the system, the EU considers that all WTO Members shoul d be ready to agree 
on the following:  
a. The pandemic is a circumstance of national emergency and therefore the requirement to 
negotiate with the right holder may be waived;  
b. To support manufacturers ready to produce vaccines or therapeutics at affordable pr ices, 
especially for low - and middle -income countries, on the basis of a compulsory licence, the 
remuneration for patent holders should reflect such affordable prices; and  
c. The compulsory licence could cover any exports destined to countries that lack 
manufacturing capacity, including via the COVAX facility.  
10.  Point (a) refers to Article 31(b) of the TRIPS Agreement, which provides that a compulsory 
licence may be granted if "the proposed user has made efforts to obtain authorisation from the right 
holder  on reasonable commercial terms and conditions and that such efforts have been unsuccessful 
for a reasonable period of time". Article 31(b) further provides that "this requirement may be waived 
by a Member in the case of a national emergency or other circu mstances of extreme urgency or in 
cases of public non -commercial use". The EU proposes to clarify that the circumstances of a 
pandemic fulfil the requirement of a national emergency and therefore the requirement to 
demonstrate the efforts to negotiate for a certain period of time can be waived. Waiving this 
requirement ensures that any WTO member can proceed quickly to issue a compulsory licence. 
Finally, paragraph 5 of Article 31 bis on compulsory licence granted for export purposes provides that 
it is with out prejudice to any provisions of the TRIPS Agreement, other than paragraphs (f) 
(predominantly for the supply of the domestic market) and (h) (adequate remuneration) of Article 
31 of the TRIPS Agreement. Therefore, the EU proposes to clarify that the wai ving of the requirement 
to negotiate with the right holder applies also in the circumstances of Article 31 bis. 
11.  Point (b) concerns a clarification of Article 31(h) on the adequate remuneration to be paid to 
the right holder. Article 31(h) provides "that the  right holder shall be paid adequate remuneration 
in the circumstances of each case, taking into account the economic value of the authorisation". 
Paragraph 2 of Article 31 bis specifies this rule for circumstances of export to countries that lack 
manufactu ring capacity. It provides that in a situation of a compulsory licence for export purposes 
the adequate remuneration is to be determined taking into account the economic value of the licence IP/C/W/680  
 
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  to the importing member. The EU proposes to clarify that in the c ircumstances of a pandemic, WTO 
Members can set the remuneration to the right holder at a level that reflects the price charged by 
the manufacturer of the vaccine or therapeutic under a compulsory licence. This would support 
production and supplies of vacc ines and therapeutics at affordable prices to low and middle -income 
countries. This should also include the case of supplies to the COVAX Facility, which is the main 
global initiative to ensure equitable and fair access to safe and effective vaccines in th e short term.  
12.  Under point (c), the EU proposes to tackle a procedural aspect of Article 31 bis and the Annex 
to the TRIPS Agreement. Under the procedure established in the Annex, each eligible importing 
Member makes a notification to the TRIPS Council that specifies in particular the names and 
quantities of the product needed. At the same time, the exporting Member must also notify the 
Council for TRIPS of the grant of the licence, including any conditions attached to it. The exporting 
Member must include th e information of the licensee, the product and the quantities, the duration 
of the licence and the "country(ies) to which the product(s) is (are) to be supplied". The EU proposes 
that in the circumstances of a pandemic, the WTO Members agree that the expor ting Member may 
provide in one single notification a list of all countries to which vaccines and therapeutics are to be 
supplied directly or through the COVAX Facility. The objective is to ensure that with a single 
notification providing the elements requi red under Article 31 bis for transparency purposes, the 
export can go ahead.  
13.  The EU considers that these elements are most urgent to ensure the full and effective application 
of the TRIPS flexibilities in relation to compulsory licences. However, the EU is  also ready to engage 
on other points regarding the facilitation of the use of compulsory licensing as provided for in the 
TRIPS Agreement. In addition, the EU is ready to consider which actions and what support the 
Council for TRIPS and each WTO Member in dividually can provide to other WTO Members to facilitate 
the use of these flexibilities in practice. The EU would also propose to recall the technical support 
offered by the Secretariat of WTO to all WTO Members that seek to use the systems of Articles 31  
and 31 bis.  
14.  Global equitable access to safe and effective COVID -19 vaccines and therapeutics is a common 
objective of all WTO Members. As a matter of urgency, the production of COVID -19 vaccines must 
be ramped up as soon as possible and their equitable an d global distribution at affordable prices 
must be ensured. It is therefore urgent for the WTO to take multilateral action on a contribution by 
the trading system towards an expansion of production and equitable access to COVID -19 vaccines 
and therapeutics . The EU considers that the proposal for a comprehensive WTO initiative for 
equitable access to COVID -19 vaccines and therapeutics encompassing the three main components, 
including but not limited to intellectual property, should facilitate finding a commo n solution among 
WTO Members and bring about a concrete urgent response to the COVID -19 crisis.  
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