South Centre Training and Research Papers
Intellectual property and patents in particular, have become one of the most debated issues on access to medicines, since the creation of the World Trade Organization (WTO) and the coming into force of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Patents are by no means the only barriers to access to life-saving medicines, but they can play a significant, or even determinant, role. During the term of patent protection, the patent holder’s ability to determine prices, in the absence of competition, can result in the medicine being unaffordable to the majority of people living in developing countries. This first issue of the “South Centre Training Materials” aims, in its first part, to provide an introduction to key issues in the field of access to medicines and intellectual property. The second part describes and defines some basic terms and concepts of this relatively new area of pharmaceuticals policies which are the trade related aspects of intellectual property rights that regulate the research, development and supply of medicines and health technologies in general.
South Centre Training Material First Issue
Medicines and Intellectual Property: 10 Years of the WHO Global Strategy
Martin Khor, Executive Director of the South Centre, noted that in this WHO Bulletin editorial Professor Carlos Correa explains some of these TRIPS flexibilities and makes the point that they are not widely used because of lack of knowledge on how to use them but also due to external pressures being put on those countries that use or try to use them. Thus a lesson that can be drawn from this editorial is that civil society and academics can play a bigger role in explaining the flexibilities and in countering moves by drug companies or governments that act on their behalf, so that the flexibilities can be more widely used.
Flexibilities provided by the Agreement on Trade-Related Aspects of Intellectual Property Rights
Carlos M Correa
Available at: http://www.who.int/bulletin/volumes/96/3/17-206896.pdf?ua=1
WHO Bulletin Editorial March 5 2018
In 1995, when the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) came into effect, all but the least-developed members of the World Trade Organization (WTO)1 were bound to provide intellectual property protection for pharmaceutical products.
The proponents of the Agreement had argued that the global strengthening of such protection would spur innovation. However, after the Agreement came into effect, there was a fall in the number of new medicines being approved annually. So far, the main impact of the Agreement on TRIPS has been on the prices of medicines. In the absence of competition, prices can be fixed – by the owners of the relevant intellectual property rights – on the basis of what the market can bear. Although treatment of hepatitis C with sofosbuvir can cost as much as 84 000 United States dollars (US$) per patient in countries where the drug has patent protection, it is expected to cost less than US$ 300 in countries where the product has not been covered by a valid patent.2
To minimize the problems caused by the Agreement, academics, governments of low-income countries, many nongovernmental organizations, the World Health Organization (WHO) and other United Nations organizations pay special attention to the Agreement’s so-called flexibilities.3,4 In this issue of the Bulletin, Ellen ‘t Hoen and others summarize the use of some of these flexibilities over 15 years.5 These flexibilities – e.g. compulsory licenses, government use for non-commercial purposes, non-exclusive protection of test data and parallel imports – can be used to mitigate the detrimental impact of the Agreement’s provisions on market dynamics and access to medicines.
The right of WTO members to exploit such flexibilities was confirmed at WTO’s Ministerial Conference in 2001.3 After 2015, both the United Nations Secretary-General’s High Level Panel on Access to Medicines6 and the panel that conducted a review of WHO’s global strategy and plan of action on public health, innovation and intellectual property7 highlighted the importance of the flexibilities in the Agreement on TRIPS. The extent to which such flexibilities have already been incorporated into national laws and practice shows substantial variation. Several compulsory licenses – allowing a company to produce a patented product or process without the consent of the patent owner – have been issued for medicines, mainly to treat infections with human immunodeficiency virus. Most of these licenses have led to substantial reductions in the costs of treatment. The use of such licenses is not limited to low- and middle-income countries. In Germany, for example, the Federal Court of Justice confirmed a compulsory license that allowed Merck to continue the commercialization of an antiretroviral drug for which another company, Shionogi, held a patent.8
Another important flexibility is provided by the definition of the standards of patentability, and the rigour with which they are applied in determining whether a claimed invention is patentable. Weaknesses or gaps in such standards can allow ever-greening by the pharmaceutical industry – e.g. the obtaining of additional patents on a different crystalline form, a new formulation or new use of a known medicine – which may be enforced to block or delay the market entry of generic equivalents. Although several countries have fine-tuned their patentability standards in order to limit ever-greening, many countries still apply inappropriately broad criteria.
Research has shown that the TRIPS flexibilities are poorly exploited and that much more could be done to align intellectual property protection with public health policies. Actions include adopting patentability guidelines, streamlining the procedures for granting compulsory licenses and training patent examiners and judges. One of the objectives of the 2018 Global Summit on Intellectual Property and Access to Medicine was to provide a strategic platform to discuss successes and setbacks for governments and civil society in resisting trade, lobbying and litigation threats that undermine the use of TRIPS flexibilities’.9 UNITAID’s call for proposals supporting access to medicines through innovative use of TRIPS flexibilities10 also points to the need for further action in this area.
In determining the extent to which the flexibilities are used, issues of classification may arise.5 The extent may be easily overestimated if, for example, we counted as a use of a TRIPS flexibility every patent application rejected due to a rigorous examination or every purchase of generic drugs made by the government of a low income country in a situation where intellectual property rights could have been enforced to prevent generic substitutions. The data should show whether the use took place in low-, middle- or high-income countries, as in the use of compulsory licenses and other flexibilities the main challenges are faced by the latter. To support the more extensive exploitation of the flexibilities provided by the Agreement on TRIPS, we need a continuous effort from academics, governments, international and nongovernmental organizations. The health of a large part of the world’s population depends on timely and effective action.
References are available
Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001-2016
Ellen FM ‘t Hoen, Jacquelyn Veraldi, Brigit Toebes & Hans V Hogerzeil
See here for the full paper:
Millions of people, particularly in low- and middle-income countries, lack access to effective pharmaceuticals, often because they are unaffordable. The 2001 Ministerial Conference of the World Trade Organization (WTO) adopted the Doha Declaration on the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement and Public Health. The declaration recognized the implications of intellectual property rights for both new medicine development and the price of medicines. The declaration outlined measures, known as TRIPS flexibilities, that WTO Members can take to ensure access to medicines for all. These measures include compulsory licensing of medicines patents and the least-developed countries pharmaceutical transition measure. The aim of this study was to document the use of TRIPS flexibilities to access lower-priced generic medicines between 2001 and 2016. Overall, 176 instances of the possible use of TRIPS flexibilities by 89 countries were identified: 100 (56.8%) involved compulsory licences or public noncommercial use licences and 40 (22.7%) involved the least-developed countries pharmaceutical transition measure. The remainder were: 1 case of parallel importation; 3 research exceptions; and 32 non-patent-related measures. Of the 176 instances, 152 (86.4%) were implemented. They covered products for treating 14 different diseases. However, 137 (77.8%) concerned medicines for human immunodeficiency virus infection and acquired immune deficiency syndrome or related diseases. The use of TRIPS flexibilities was found to be more frequent than is commonly assumed. Given the problems faced by countries today in procuring high-priced, patented medicines, the practical, legal pathway provided by TRIPS flexibilities for accessing lower-cost generic equivalents is increasingly important.
Intellectual Property Issues
CSOs concerned over timing of IP policy review in India
Published in SUNS #7881 dated 25 September 2014
TWN Info Service on WTO and Trade Issues (Sept14/11) 26 September 2014
Third World Network www.twn.my
Geneva, 24 Sep (Kanaga Raja) — Ahead of Indian Prime Minister Narendra Modi’s visit to the United States, a number of civil society organisations (CSOs) and prominent individuals in India have raised concerns over the timing of a Ministry-level review of the country’s intellectual property rights (IPR) policy.
The groups underlined that India’s IPR policy is TRIPS-compliant, and that India chose to use the health safeguards available in the TRIPS Agreement, to protect the interests of Indian patients as well as millions of people living in other developing countries.
The law requires that patented inventions are available to the public at affordable prices as well as obligates the patent holders to work their patents in India. By making use of flexibilities in the TRIPS agreement, the Indian Patents Act and policy reduce options to pharmaceutical companies, be they Indian or foreign, to profit from diseases or those suffering from them.
“The Indian law has stood the test of time and judicial scrutiny. It is also increasingly serving as model legislation for many developing countries including Brazil,” the statement stressed. The CSOs are concerned about the implications of the Minister’s statement, linking innovation with strengthened IP protection. Read more here