The biggest problem with compulsory licensing, as described in the TRIPS Agreement and its amendment, is that they are not drafted as a minimum standard that countries must apply in their national legislation to be TRIPS compliant. Rather, it is an option available to Member States for transposition into their national legislation. As a result, only five countries and territories that have the pharmaceutical capacity to be exporting countries under compulsory licences have actually made progress in transposing these measures into their national law (18). If the Doha Declaration is considered to be an accurate reflection of the feelings of nations, provisions on compulsory licensing should be included in the TRIPS Agreement as an obligation for Member States. At the very least, where separate categories of medicinal products are created, as set out in the first Recommendation, provisions on compulsory licensing of essential medicinal products should be required in order to comply with TRIPS. A wide range of drugs are developed and manufactured by pharmaceutical companies, and the TRIPS Agreement must distinguish between patents for Viagra and patents for efavirenz. It is reasonable to demand full 20 years of intellectual property protection for `chemical toys` (17), but when it comes to life-saving life-saving life-saving medicines, certain concessions must be made in favour of promoting public health. The term `essential medicinal product` should be defined in the context of the TRIPS Agreement, not in relation to a list of diseases, as has been proposed in the past, (18) but as a general description of what constitutes the difference between an essential and a non-essential medicinal product. The possible criteria for inclusion in such a category would be: availability of an alternative treatment, severity of the disease that the drug is intended to treat, and the ability of the patentee to adequately supply the markets that require the patented product.
However, in order to benefit from separate definitions, separate provisions should be made, where appropriate. Ideally, two distinct groups of patent laws would exist in parallel; one applies to medicines that are considered essential and the other applies to non-essential medicines. Since the entry into force of travel, it has been criticized by developing countries, academics and non-governmental organizations. While some of these criticisms are directed at the WTO in general, many proponents of trade liberalization also view the TRIPS Agreement as bad policy. The concentration effects of the TRIPS Agreement`s wealth (money from people in developing countries to copyright and patent holders in developed countries) and the imposition of artificial scarcity on citizens of countries that would otherwise have had weaker intellectual property laws are common ground for such criticism. Other criticisms have focused on TRIPS` inability to accelerate the flow of investment and technology to low-income countries, an advantage advanced by WTO members in the run-up to the agreement. World Bank statements suggest that the TRIPS Agreement has not led to a demonstrable acceleration of investment in low-income countries, although this may have been the case for middle-income countries. [33] The long duration of TRIPS patents was assessed for an unreasonable slowdown in generic substitute market entry and competition. In particular, the illegality of preclinical studies or the submission of samples for approval until a patent expires has been accused of driving the growth of a few multinationals rather than manufacturers in developing countries.
3The June deadline was not agreed upon and was subsequently extended to March 2005. The March deadline also passed without an agreement, but on 6 December 2005, the WTO finally reached consensus on amending the TRIPS Agreement. This amendment follows on from the 30. August 2003. Member States have until 1 December 2007 to ratify the amendment so that it can be formally incorporated into the TRIPS Agreement. 7This statement is irrefutable and redundant, but will play an important role in the criticism. Its function is to limit the scope of criticism to the provisions and implementation of the TRIPS Agreement itself and not to its existence or factors outside its competence. The aim is to apply the recommendations directly to the current legal framework. Finally, it should be recalled that the lack of access of developing countries to life-saving medicines is due to a number of factors; an unprecedented level of international cooperation and empathy will be needed to make meaningful progress on this issue.
However, this paper focuses on the factor that has received the most attention: the WTO and its TRIPS Agreement. The reason why this facet of the problem is highlighted in this document is threefold: unlike other intellectual property agreements, the TRIPS Agreement has a powerful enforcement mechanism. States can be sanctioned by the WTO dispute settlement mechanism. In a press release, WTO Director-General Supachai Panitchpakdi called the decision a “historic agreement.” Panitchpakdi continued: “This proves once and for all that [the WTO] can deal with both humanitarian and trade issues. This particular issue was particularly difficult. The fact that WTO members have managed to find a compromise on such a complex issue is a testament to their goodwill. (5) Developed world leaders welcomed this decision as a dramatic development in international intellectual property law. UN Secretary-General Kofi Annan said: “Intellectual property protection is essential to advance new medicines, vaccines and diagnostics that are urgently needed for the health of the world`s poorest people. The United Nations fully supports the TRIPS Agreement, including the safeguards contained therein.
(13) The TRIPS Agreement is the ideal point for the World Trade Organisation`s punch bag. Just or not, the TRIPS agreement is supposed to be a monstrosity of modern capitalism. Noam Chomsky, a renowned academic, says: “There is nothing liberal about [the TRIPS agreement]. It is a highly protected system designed to ensure that private tyrannies, such as corporations, monopolize the technology and knowledge of the future. (14) Dr Zafar Mirza, executive coordinator of The Network, a Pakistani health advocacy group, asks: “You talk about harmonising trade policy, but no one says a word about harmonising global socio-economic conditions. All countries are at different stages of development, how could they be regulated by the same law? (15) These remarks contrast sharply with those quoted above by senior officials. Why is one group so strongly opposed to the TRIPS Agreement, while another shows seemingly infallible support? The second part of this article attempts to reconcile these two points of view. Article 31 of the TRIPS Agreement sets out the conditions for the use of compulsory licences by Member States. It begins with the words `Where the right of a member permits any other use of the subject matter of a patent without the authorisation of the rightholder` (6) as regards compulsory licences. The wording of the article clearly allows Member States to adopt national laws for the protection of intellectual property without provisions on compulsory importation, while respecting the TRIPS Agreement, the Doha Declaration and the Decision of 30 August 2003.
The concept of compulsory licensing has very little value for public health if the only countries that adopt it are those that do not have the capacity to manufacture pharmaceuticals. While it is true that parallel imports are also formulated as an option rather than an obligation, they are not such a serious problem, since for a country to benefit from parallel imports, it only needs to amend its own national legislation to make this possible; it does not depend on the cooperation of other nations. On the other hand, a developing country can only benefit from a compulsory licence if the more developed countries implement it in their own legislation. Paragraph 11 of the Agreement also states that amendments to the TRIPS Agreement will be made to reflect these decisions by June 2004; 3 The following recommendations focus on the above arguments and aim to improve the public health situation within the framework of the existing TRIPS Agreement. Parallel imports allow a developing country to take advantage of current practice according to drug prices in different countries. For example, if a package of nevirapine, a patented medicine, is sold for $250.00 in France and for $275.00 in South Africa, a South African company (or the government itself) can import the drug from France and sell it at a lower price without the permission of the South African patent holder. Parallel imports allow countries to purchase patented medicines at the lowest price in the world. The right to parallel imports under the TRIPS Agreement is based on a fundamental legal principle known as the `exhaustion` of intellectual property rights, which defines the date on which a patent holder no longer has exclusive rights in connection with the resale of his product (5). .