Doha and Public Health
Chapter Seventeen
Syllabus topic 1.3, "International Conventions and treaties regarding patents."
Pages 66 to 69 of 524
In one line
The Doha Declaration is the 2001 statement by every World Trade Organization member that TRIPS must not stop a country protecting public health, and it led to the one amendment TRIPS has ever had.
In the wording a student can write in an exam: the Declaration on the TRIPS Agreement and Public Health, adopted at the Fourth Ministerial Conference at Doha on 14 November 2001, affirms that the Agreement can and should be interpreted and implemented in a manner supportive of members' right to protect public health and, in particular, to promote access to medicines for all.
Why it was needed six years after TRIPS
Because TRIPS worked, and the consequences arrived. By 2000 antiretroviral treatment for a patient with human immunodeficiency virus cost between ten and fifteen thousand United States dollars a year at patented prices, and generic Indian manufacturers had begun offering the same combinations for a few hundred. In sub-Saharan Africa the arithmetic was a matter of life and death.
Two events crystallised the argument. In 1998 a large group of pharmaceutical companies sued the South African government over legislation permitting parallel importation and substitution, and withdrew in 2001 under public pressure. In 1997 the United States began dispute proceedings against Brazil over the local working requirement in its patent law, and later withdrew.
Developing members went to Doha saying that the flexibilities TRIPS contained were being chilled by the threat of litigation and trade pressure. The Declaration was the answer, and it was adopted by consensus, which means the developed members agreed to it.
What the Declaration says
Paragraph 4 is the heart of it. Members agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health, and that the Agreement can and should be interpreted and implemented in a manner supportive of members' right to protect public health and, in particular, to promote access to medicines for all.
Paragraph 5 lists the flexibilities and confirms them. Each provision of TRIPS shall be read in the light of its object and purpose as expressed in its objectives and principles, meaning articles 7 and 8. Each member has the right to grant compulsory licences and the freedom to determine the grounds on which they are granted. Each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to human immunodeficiency virus, tuberculosis, malaria and other epidemics, can represent such circumstances. Each member is free to establish its own regime for the exhaustion of intellectual property rights, which is the basis for parallel importation.
Paragraph 6 states the problem the Declaration could not solve. Members with insufficient or no manufacturing capacity in the pharmaceutical sector could make effective use of compulsory licensing only with difficulty, because article 31(f) required production under a compulsory licence to be predominantly for the domestic market. A country with no factory could licence nobody usefully. The Council for TRIPS was instructed to find an expeditious solution.
Doha and Public Health
Paragraph 7 extended the transition for least-developed members in respect of pharmaceutical products to 1 January 2016, later extended further.
What followed: the paragraph 6 system
The 30 August 2003 decision. The General Council waived article 31(f) for exporting members and article 31(h) for importing members, on conditions: the importing member must notify its needs, the exporting member must licence only the quantity needed, the product must be distinctively packaged and marked, and details must be posted on a website.
The 6 December 2005 protocol. The waiver was made permanent by inserting article 31bis and an Annex into TRIPS. The amendment entered into force on 23 January 2017 when two thirds of members had accepted it. India accepted it in March 2007. This is the only amendment TRIPS has ever had.
Section 92A of the Indian Patents Act is India's expression of it. Inserted by the Patents (Amendment) Act 2005, it allows a compulsory licence for the manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity to address public health problems, provided that country has granted a compulsory licence or notified allowance of importation. Chapter 820 works it through, including the fact that it has never once been used.
A worked example
A landlocked African member faces an outbreak of a resistant tuberculosis strain. The only effective medicine is patented there and in India, and the country has no pharmaceutical manufacturing industry.
What it cannot do. It cannot usefully grant a compulsory licence to a domestic manufacturer, because there is none. Before 2003 it also could not obtain the medicine from an Indian manufacturer under an Indian compulsory licence, because article 31(f) required Indian production under such a licence to be predominantly for the Indian market.
What the paragraph 6 system lets it do. It notifies the Council for TRIPS of the name and quantity of the product needed, confirms it has insufficient manufacturing capacity, and either grants a compulsory licence itself or notifies that it will allow importation.
An Indian manufacturer then applies to the Controller under section 92A. The Controller may grant a compulsory licence solely for manufacture and export to that country, on terms and at a royalty the Controller fixes. The product must be distinctively packaged so that it cannot be diverted into other markets.
And section 92A(3) is worth noting, because it says that the provision does not prejudice the extent to which patented pharmaceutical products produced under any other compulsory licence can be exported.
Doha and Public Health
Legal status: what a Declaration is and is not
It is not an amendment. The Declaration did not change a word of TRIPS. It is a Ministerial Declaration adopted by consensus.
But it is not merely political either. Under article 31 of the Vienna Convention on the Law of Treaties a treaty is interpreted in the light of any subsequent agreement between the parties regarding its interpretation. A declaration adopted by consensus by all members about the meaning of their own treaty is exactly that, and panels and the Appellate Body have treated it accordingly.
The amendment, article 31bis, is a different thing. It is binding treaty text and it entered into force on 23 January 2017 for members that had accepted it.
What it does NOT mean
It does not suspend patents in a health emergency. It confirms that a member may use the flexibilities TRIPS already contained, above all compulsory licensing, and that it may decide for itself what an emergency is. The patent stands and the patentee is paid.
It does not give a member a free hand. The conditions in article 31 still apply, and the paragraph 6 system carries its own notification and anti-diversion conditions.
And it did not solve the access problem. The article 31bis mechanism has been used once in the world, by Canada to export an antiretroviral to Rwanda in 2007 to 2008, and section 92A has never been used in India. Chapter 820 records why the mechanism is thought to be too cumbersome.
Quick revision
Doha Declaration on the TRIPS Agreement and Public Health, adopted 14 November 2001 at the Fourth Ministerial Conference.
Paragraph 4: TRIPS does not and should not prevent members from taking measures to protect public health, and must be interpreted and implemented supportively of that right.
Paragraph 5: read TRIPS in the light of articles 7 and 8; each member may grant compulsory licences and determine the grounds; each member decides what is a national emergency, and public health crises can be one; each member sets its own exhaustion regime.
Paragraph 6: the problem of members with no manufacturing capacity, referred to the Council for TRIPS.
30 August 2003 waiver; 6 December 2005 protocol inserting article 31bis; in force 23 January 2017. India accepted in March 2007.
India's expression: section 92A of the Patents Act 1970, inserted in 2005, never yet used.
Test yourself
1. What is the legal status of the Doha Declaration? It is a Ministerial Declaration adopted by consensus, not an amendment. It binds interpretation as a subsequent agreement of the parties about the meaning of their treaty, under article 31 of the Vienna Convention on the Law of Treaties.
Doha and Public Health
2. What problem did paragraph 6 identify and how was it solved? That a member with insufficient or no pharmaceutical manufacturing capacity could not make effective use of compulsory licensing because article 31(f) required production to be predominantly for the domestic market. It was solved by the waiver of 30 August 2003 and then permanently by article 31bis, in force 23 January 2017.
3. Which Indian provision carries out the paragraph 6 system? Section 92A of the Patents Act 1970, allowing a compulsory licence for the manufacture and export of patented pharmaceutical products to a country with insufficient or no manufacturing capacity that has granted a compulsory licence or notified allowance of importation.
4. Does the Declaration allow a country to ignore a patent during an epidemic? No. It confirms the member's freedom to use the flexibilities TRIPS contains, principally compulsory licensing, and its freedom to decide what an emergency is. The patent remains and adequate remuneration is payable.
The rest of this subject
These notes are cut from the University's printed syllabus. Open the syllabus itself, or the past papers, for the same subject.