Intellectual property regimes are usually assumed to exert positive enticements on technological innovation. However, given the serious nature of access to critical health technologies for most of the worldâ€™s population, it is worth revisiting this presumption for health technologies. The reasons contributing to this situation range from weak supply systems to exorbitant prices. The factors that stimulate innovation are often biased against conditions that excessively affect the populations of developing nations. For example, there were only 11 medicines for tropical diseases amongst1325 new medicines launched between 1975 and 1997.[ii] The amalgamation of market failure and under-investment by the public sector discourages the innovation in developing countries. The procedure of bringing a new product to the market is both costly and lengthy. Due to the resource implications and the uncertainties involved, creating an environment favorable to successful innovation is indispensable.Therefore the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) took the initiative to undertake the strenuous task of balancing private and public interests. On one side, it protects the interests of the pharmaceutical companies that invest heavily in research and development of drugs, while on the other hand, it allows nations that are a member of World Trade Organisation (WTO) to support public health in their respective countries. It allows developing and least developed countries to have the benefit of a moratorium[iii] on implementing pharmaceutical patents until the years 2005 and 2016 respectively. However, this is of little consolation[iv]since the dispensation has been effectively neutralized by industrially developed nations. For example, a number of pharmaceutical companies challenged the South African legislation authorized the minister of health to issue compulsory license under certain circumstances. The law was based on the hypothesis that expensive drugs were unaffordable to large sections of society and that the following lack of access to drugs was leading to a serious health crisis within the country. The action of the pharmaceutical industry against the South African initiative led to widespread criticism of the TRIPS agreement by the developing world, NGOs and human rights activists led to the Doha Declaration on Public Health of November 2001. Once TRIPS was adopted in 1994, developing and least developed countries were obliged to effect changes in their patent laws in accordance with the agreement. But, in the meantime, they were to provide Exclusive Marketing Rights (EMR)[v] to those who had obtained patents in other member countries on or after the date of the entry into force of the TRIPS agreement. They were also required to create a mechanism to enable the filing of patent applications pending the expiry of the moratorium on the implementation of pharmaceutical patents. The objective of the Doha Declaration on the TRIPS Agreement and Public Health was to clarify the official stand on certain provisions of TRIPS relating to public health. It recognises the concerns of developing countries and LDCs on the issue. The Declaration clarifies that 'public health crises' can represent 'a national emergency or other circumstances of extreme urgency', and that an 'emergency' may be either a short-term problem, or a long-lasting situation.[vi] It recognises the gravity of the public health problems afflicting many developing and least developed countries.[vii]It accepts legitimate concerns regarding the pricing of drugs, its effect on access to drugs and the impact of lack of access on public health.[viii]At the same time, it acknowledges that intellectual property protection is important for the development of new medicines. It also reiterates that the agreement should be interpreted and implemented in the light of members' right to protect public health and promote access to medicines for all.[ix] However there are few significant gaps in the Doha Declaration which makes it vulnerable to narrow interpretations:
- It does not define the term 'public health'. This leaves the interpretation at the mercy of the whims and fancies of the WTO Dispute Settlement Body.
- It does not recognize the general problems faced by developing countries in promoting public health. The pharmaceutical industry would certainly like to interpret this provision restrictively, leaving out certain diseases prevalent in member countries which may not be internationally acknowledged as epidemics.[x]
- Another inherent defect is built into the system through the condition that member countries can make use of options such as the compulsory license mechanism to promote public health only when a health crisis has arisen. This limitation clearly weakens their right to utilise the obvious flexibility to take preventive and precautionary action before a disease becomes a full-blown crisis.
- The Declaration does recognise the problems posed by the pricing of drugs and the impact of this on access. At the same time, it accepts the significance of intellectual property rights for the development of new medicines. Through this apparent even-handedness it does little to reassure member countries that they can undertake action to ensure wider access to medicines without the threat of legal disputes.
- Further, the Declaration states that the agreement has to be interpreted in the light of its objectives and principles, which means it has to be read with Articles 7 and 8 of TRIPS. Those provisions are liable to be interpreted by developed countries to justify increased patent protection so that pharmaceutical companies can carry out research and development. R&D costs are invariably cited as the inevitable reason for the high price of drugs, which naturally put them out of the reach of most people in developing countries,[xi]leading to the situation prior to the Doha Declaration.
- Also there are other issues such as parallel imports[xii] and compulsory licensing[xiii] which the Doha Declaration tries to address. However it has widened the differences in interpretations and opinions amongst industrialized societies and the developing countries.
[i] http://infochangeindia.org/trade-a-development/intellectual-property-rights/trips-and-public-health.html [ii] http://www.ncbi.nlm.nih.gov/books/NBK11723/ [iii] Paragraph 7 of the Doha Declaration on Public Health [iv] (US-India mailbox case) referred in: Frederick.M.Abbott, (2002) "The TRIPs Agreement, Access to Medicines, and the WTO Doha Ministerial Conference," Journal of World [v] A patent, enabling manufacturers to have the exclusive right to market their products in a country even though the product has not been examined for novelty or non-obviousness in the country concerned. [vi] Carlos Correa, Implications of Doha Declaration on the TRIPS Agreement and Public Health [vii] Paragraph 1 of the Doha Declaration on TRIPS Agreement and Public Health [viii] Paragraph 3 of the Doha Declaration on TRIPS Agreement and Public Health [ix] Paragraph 5 (c) of the Doha Declaration on TRIPS Agreement and Public Health [x] Oxfam Report [xi] Ellen 't Hoen, (2002), TRIPS, Pharmaceutical patents, and access to essential medicines: a long way from Seattle to Doha, Chicago Journal of International Law [xii] Parallel imports take place when a product sold by a patent holder in one country is exported by a buyer to another country where the price for the same patented drug is higher. [xiii] Compulsory licensing refers to permission from a government to produce the patented product or process without the consent of the patent owner.