This article is written by Ananaya Shee of 2nd year of Narsee Monjee Institute of Management Studies, Bangalore.
Abstract
The Doha Declaration is a significant document that emerged from the World Trade Organization’s Ministerial Conference held in Doha, Qatar, in 2001. This declaration outlines a comprehensive set of commitments and principles aimed at addressing various global trade issues, with a particular focus on fostering development and improving access to essential medicines. Key aspects include the reaffirmation of the principles of non-discrimination, the recognition of the special needs of developing countries, and the acknowledgment of the relationship between intellectual property rights and public health. The Doha Declaration, by emphasizing the importance of flexibility in implementing trade agreements, especially concerning public health concerns, represents a pivotal moment in international efforts to balance trade policies with broader developmental objectives.
Key words- Doha, intellectual property rights, trade agreements.
History-
In 2005, WTO members reached agreement on an amendment to the TRIPS Agreement to make permanent the temporary waiver contained in the August 30 WTO Decision, which itself fulfilled the requirement of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health of November 14, 2001. This decision created a mechanism to allow WTO members to issue compulsory licences to export generic versions of patented medicines to countries with insufficient or no manufacturing capacity in the pharmaceutical sector. The 2005 Ministerial Declaration stated:
“We reaffirm the importance we attach to the General Council Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, and to an amendment to the TRIPS Agreement replacing its provisions. In this regard, we welcome the work that has taken place in the Council for TRIPS and the Decision of the General Council of 6 December 2005 on an Amendment of the TRIPS Agreement.”
The amendment, the first ever to the TRIPS Agreement, was circulated to WTO members for formal adoption. A deadline of December 1, 2007 was set for members to accept the permanent amendment. For the amendment to be put into effect, at least two-thirds of members must formally adopt it.
On November 30, 2007, Peter Mandelson, the then European Union’s Trade Commissioner, announced that the European Union formally accepted the World Trade Organization -approved protocol of December 2005, amending the TRIPS Agreement. However, in order for the decision to have legal effect, two-thirds of the WTO’s 153 Members are required to ratify the agreement. The current total of Members accepting the amendment is 45.
In 2008, a decision was made to extend the deadline for accepting the TRIPS agreement amendment. The deadline was extended until 31 December 2009 or “such later date as may be decided by the Ministerial Conference.” The General Council further extended the deadline in 2011 to 31 December 2013.
In 2017, after further extensions, enough members ratified the amendment to reach the two-thirds threshold, bringing the TRIPS amendment into effect.
The Doha Declaration and the right to health
The Doha Declaration does not explicitly refer to the right to health. However, the recognition that the TRIPS Agreement” can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all” is crucial for the realization of that right. Article 25 of the Universal Declaration of Human Rights (1948) recognises that a standard of living adequate for the health and well-being of the individual and that person’s family, including medical care, is a right to which all human beings are inherently entitled to. Article 12 of the International Covenant on Economic, Social and Cultural Rights (1966) requires that States take steps necessary for the full realization of this right, including those steps necessary for: the reduction of infant mortality and for the healthy development of the child; the prevention, treatment and control of epidemic, endemic, occupational and other diseases; and the creation of conditions which would assure to all medical service and medical attention to all in the event of sickness.
The presence of a right to health in several national constitutions has helped to focus attention on the problem of access to medicines. In South Africa, the right to health care services, including reproductive health care, is enshrined in Section 27.1(a) of the Constitution and can be read in conjunction with the obligation on the state to take reasonable legislative and other measures, within its available resources, to achieve the progressive realization of each of these rights (section 27.2) and the right of every child to basic health care services (section 28.1). These human rights became the basis of a complaint related to access to patented pharmaceutical products that was brought before the South African Constitutional Court in July 2002. The applicants, the Treatment Action Campaign (TAC), were concerned that the refusal of the South African government to make the ARV nevirapine available in the public health sector and not setting out a timeframe for a national programme to prevent mother-to-child transmission (MTCT) of HIV breached these terms. Finding in favour of the applicants, the South African Constitutional Court held that sections 27.1 and 27.2 of the Constitution require the government to devise and implement within its available resources a comprehensive and coordinated programme to realize progressively the rights of pregnant women and their newborn children to have access to health services to combat MTCT of HIV. The Court also confirmed that the State is obliged to ensure that children are accorded the protection contemplated by section 28.1(c) of the Constitution. The South African government was ordered to remove the restrictions that prevent nevirapine from being made available for the purpose of reducing the risk of MTCT of HIV without delay.
Using TRIPS flexibilities to attain the right to health: successes and challenges
A number of experiences in developing countries show how the use of TRIPS flexibilities may be instrumental in pursuing public health objectives. After failed attempts to negotiate a price reduction for the ARV drug Kaletra® with Abbott, in June 2005 Brazil’s Minister of Health signed a decree declaring Kaletra® to be in the public interest, paving the way for compulsory licence and the manufacture of a generic version of Kaletra® to be produced by the Farmanguinhos laboratory of the Oswaldo Cruz Foundation. However, at the same time that it declared Kaletra® to be in the public interest, the Brazilian government gave Abbott a timeframe in which to offer a lower price for the drug and so avert the compulsory licence from being issued. Subsequently, in October 2005, an agreement was reached between the Brazilian Federal Government and Abbott to supply the drug at a lower price than had previously been available. In return for a lower price, the Brazilian Federal Government undertook to increase the number of patients prescribed Kaletra®, and to refrain from issuing a compulsory licence or engage in other technology transfer or foreign direct investment activities to manufacture Kaletra® locally, and fixing the stipulated price until the end of 2011, when the patent for Kaletra® would be close to expiry.
Later, in May 2007, the Brazilian government took the decision to grant a compulsory licence on a patent relating to efavirenz, an ARV of growing importance in the successful national programme to treat HIV. A remuneration of 1.5 percent of the price of the generic medicine was offered to the originator. The compulsory licence allowed the government to obtain the drug at 28 percent of the price of the original product.
In India, the use of TRIPS flexibilities has focused on Article 27.1 of the TRIPS Agreement. When India became a founding Member of the WTO, it was obliged to introduce a series of amendments to the Patents Act of 1970 that were designed to ensure compatibility with obligations set out in the TRIPS Agreement. These amendments included measures designed to meet the obligation contained in Article 27.1 of the TRIPS Agreement to extend patent protection to all fields of technology, including food, pharmaceutical and chemical products. In drafting legislative amendments to comply with its obligations under the TRIPS Agreement, India was also keen to address concerns about the adverse impact of compliance, particularly the likely implications of the TRIPS Agreement for the human right to life as enshrined in the Indian Constitution.
To ensure that the constitutional right to life is respected, Section 3(d) of the Indian Patents (Third Amendment) Act of 2005 set out that the mere discovery of a new form of a known substance is not to be considered an invention but that this could be regarded as such if it enhances the efficiency of a known invention. An explanation to that Section clarified that salts, polymers and other new versions are to be treated as the same substance and not as new, patentable forms unless they differ in their properties significantly with regard to efficacy. Although raising concerns for patentees that Section 3(d) excludes some applications that, on the usual criteria of patentability, would qualify as inventions, the provision has been described as an essential tool for keeping open the door for generic manufacture of medicines.
As a result of Section 3(d), a patent claim relating to a pharmaceutical product may relate to an active ingredient as such independently of or jointly with formulations, salts, prodrugs, isomers and so on, or cover any of these subject matters separately, but subject to a higher standard of inventive activity. This provided India with considerable flexibility to determine what constitutes an invention for the purposes of granting a patent and allows it to draw a distinction between genuinely patentable inventions and the practice of ‘evergreening’ spurious inventions. Furthermore, the Indian Patents Act of 2005 retained pre-grant opposition, which allows third parties to oppose patent applications prior to grant. Since “any person” may have legal standing to bring pre-grant oppositions proceedings, generic producers and patient groups have been able to initiate numerous successful pre-grant oppositions under Section 3(d) of the Act. In addition, the 2005 amendment introduced post-grant opposition, thereby offering the possibility of re-examining a patent application afresh. The utilization of compulsory licences in Thailand also provides a telling example of the use of TRIPS flexibilities. The Thai Patent Act 1999 contains provisions for compulsory licensing in Section 51, which provides that, to carry out any service for public consumption, any government ministry, bureau or department may exercise the rights in any patent without the requirement of prior negotiation with the patentee. Its objective relates specifically to non-commercial purposes and public interests – for example, the public health service. In 2006 the Thai government issued compulsory licences for a number of medicines used to treat HIV, cancer and heart disease.
Finally, competition law is another tool that may be used to increase access to treatment if hampered by anti-competitive practices, including – in some countries – excessive pricing. Actions under competition law may be initiated by the governments themselves, competitors and, depending on local legislation, by patients and civil society. Article 31(k) of the TRIPS Agreement enables compulsory licences to be granted on grounds of remedying anti-competitive abuses, such as excessive pricing, refusals to licence or the denial of an essential facility. A rare, but telling, example of the use of competition law in a developing country as a tool to increase access to medicines was a decision by the South African Competition Commission in 2003. It found that two pharmaceutical firms had abused their dominant position in the ARV market by denying “a competitor access to an essential facility.
References-
- This article was originally written by Carlos Correa published on undp.org/ website. The link for the same is herein. https://www.undp.org/sites/g/files/zskgke326/files/publications/Discussion_Paper_Doha_Declaration_Public_Health.pdf
- https://www.wto.org/english/tratop_e/trips_e/healthdeclexpln_e.htm
- https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001154
- en.wikipedia.org/wiki/Doha_Declaration#:~:text=This%20decision%20created%20a%20mechanism,capacity%20in%20the%20pharmaceutical%20sector