The Commission on Intellectual Property Rights (CIPR) constituted by the government of UK to study the implications of the patent law provisions and TRIPs agreement on the development of the generic industry, and the availability of drugs covered by patents to people has in its report suggested that there are no circumstances in which the most fundamental human rights should be subordinated to the requirements of IP protection.
The CIPR was constituted by the UK government following upon a series of specially called conferences of UN General Assembly, WHO, UNAIDS, UN Human Rights Commission, WTO and others expressing serious concern at the plight of the people and outrageous drug prices, the WTO Ministerial Conference held at Doha in November 2001, issued a landmark Declaration on TRIPs and Public Health. Declaring primacy of healthcare over trade rights and providing correct guidance for implementing TRIPs for promoting and protecting the health of people, it adopted the goal of 'Access to Medicines for All.'
The CIPR report, which was published on September 12, 2002, also points out that the IP rights are granted by states for limited times (at least in the case of patents and copyrights) whereas human rights are inalienable and universal.
The last one year has witnessed not only the worst in human exploitation of drug patents at the cost of millions of human lives, but also increasing awareness in the international community, of the adverse impact of strong product patent regimes in respect of drugs and medicines. Such patent regime has been used to support skyrocketing prices of vital life saving drugs leading to heavy death toll of millions of victims of AIDS/HIV and other pandemics. Many innocent women and children died because neither they nor their governments were able to pay the unconscionably high prices claimed by MNCs for their patented drugs.
The adverse impact of the prices of patented drugs was felt even in countries like USA where, senior citizens and uninsured people had to take bus rides to Canada to buy their requirements of drugs patented and produced by US companies, marketed in Canada at 25% of the US prices. The Governors of many US States and MNCs like GE and others protested against the abuse of patent rights, by prolonging patent protection beyond the statutory period of 20 years to claim exploitative prices. The US Senate, after a prolonged debate, by an overwhelming majority also adopted the Greater Access to Pharmaceuticals Act 2002 to curb such practices.
The WHO and WTO sponsored a joint study on the implications of trade rules and healthcare, and released the Report of the joint study on 22nd August 2002. This Report provides clarifications and guidance for WTO Members for implementing the TRIPs and other health-related WTO Agreements. This Report gives practical guidance for actual implementation, giving effect to the various public interest and healthcare recommendations of the Doha Declaration.
The CIPR report also states that too often, the interests of the "producer" dominate in the evolution of IP policy, and those of the ultimate consumer are either not heard or heeded. In IPR discussions between developed and developed countries, a similar imbalance exists. The other findings of the commission is as follows:
* Intellectual property systems may, if we are not careful, introduce distortions that are detrimental to the interests of developing countries.
* The contemporary evidence suggests that, because developing countries are large net importers of technology from the developed world, the globalisation of IP protection will result in very substantial additional net transfers from developing to developed countries.
* There is much less evidence from developing countries indicating that IPR systems are a key stimulus for innovation. But the evidence suggests that the IP system hardly plays any role in stimulating research on diseases particularly prevalent in developing countries, except for those diseases where there is also a substantial market in the developed world (e.g. diabetes or heart disease).
* The evidence also suggests that patent protection has an effect on the prices charged for medicines. In developed countries, generic competition causes prices to fall quite sharply, particularly if the market is large enough to support a number of generic competitors. In the absence of patents in developing countries, more people would be able to afford treatments they need. When TRIPS comes fully into force after 2005, particularly when countries such as India have to introduce patent protection, the existing competition from generic suppliers will diminish.
* The IP system is one factor among several that affects poor people's access to healthcare.
* As intellectual property rights are strengthened globally, the cost of medicines in developing countries is likely to increase, unless effective steps are taken to facilitate their availability at lower cost in developing countries. There are a number of IP policies that both developed and developing countries can adopt to promote cheaper prices for medicines in developing countries which the Commission does not believe will adversely affect the incentives for research on relevant diseases.
* Apart from international measures to facilitate access to medicines, developing countries need to adopt IP rules in their legislation and practices that limit the extent of patenting and facilitate the introduction of generic competition.
Countries need to ensure that their IP protection regimes do not run counter to their public health policies and that they are consistent with and supportive of such policies.
However, developing countries should aim to facilitate in their legislation their ability to import patented medicines if they can get them cheaper elsewhere in the world. TRIPS allow countries to set their own rules on what are technically called "parallel imports.
Developing countries should establish workable laws and procedures to allow them to use compulsory licensing. They should also make similar provisions for what is called "government use." Many developed countries have such laws that allow their governments to make use of patented inventions without infringing a patent under a wide range of circumstances.
How the issue of facilitating compulsory licensing for developing countries with inadequate manufacturing capacity is to be resolved is currently being debated in the TRIPS Council. It raises a number of quite detailed legal and practical matters. A way needs to be found to reconcile the nature of the solution adopted with the objective of providing medicines of the appropriate quality at the lowest possible cost. If that cannot be achieved, the solution will have little practical reality. Whatever the solution adopted, it should be capable of quick and easy implementation to ensure that the real needs of poor people in developing countries are given priority. And it should establish conditions that provide potential suppliers with the necessary economic incentive to export medicines that are needed by these countries.
Therefore developing countries should aim for strict standards of patentability to avoid granting patents that may have limited value in relation to their health objectives. Such systems should aim to promote competition, and provide safeguards in the event of abuses of the patent system.
For instance, most developing countries should exclude diagnostic, therapeutic and surgical methods from patentability, including new uses of known products, as permitted under TRIPS.
Developing countries should also make provisions in their law that will facilitate the entry of generic competitors as soon as the patent has expired on a particular drug. One of these provisions (the "Bolar exception") allows generic companies to develop their versions of patented drugs during the term of the patent without infringing it. Another one would be to make it easier and cheaper for generic companies to get regulatory approval for drugs similar to registered drugs, while providing for the protection of test data (e.g. clinical trials data companies require to get approval from regulators such as the FDA in the US) against unfair commercial use.