252. I would first like to thank the delegations of China, India, Fiji and South Africa who are also co-sponsoring this agenda item.
253. The proposal for inclusion of the item on 'Intellectual Property and the Public Interest' aims at spurring the discussion regarding the many facets of IP within the broader socio-economic framework of Members. The complex and complementary relationship between these aspects is a topic that merits careful reflection and broad discussion by Members.
254. IP addresses the public interest by providing incentives for innovation. At the same time, governments have the responsibility of safeguarding the public against its potential negative impact, notably on competition. A balanced IP system, therefore, provides powerful incentives for innovation with the least effects on the competitive landscape; in economic terms, it will stimulate the pro-competitive dynamic effects of intellectual property while limiting and controlling its potential anticompetitive static effects.
255. An efficient IP system, by definition, results from a delicate balancing act. There is no one size-fits-all approach. Rather, a flexible policy space is necessary to allow each Member to develop and adapt the set of IP regulations more adequate for its individual reality. This is to be done, of course, within the boundaries of the internationally agreed objectives, principles and standards, to ensure predictability and mutual confidence. One of the tools to reach that result is the use of exceptions and limitation to IP rights, an intrinsic element of the law of every Member. They serve a number of purposes by conferring the necessary flexibility to guarantee national security and to shape public policies to meet, inter alia, development, competition, and health surveillance goals. Therefore, they will generate an increased societal welfare without unreasonably prejudicing the legitimate interests of the patent owner.
256. In recognition of the underlying public policy objectives of national systems for the protection of intellectual property, including developmental and technological objectives, Articles 7 and 8 TRIPS contain clear language regarding the relationship between public interest and the protection and enforcement of intellectual property rights.
257. The discussion under this agenda item has, among its goals, the increase of knowledge regarding those aspects and the exploration of possible solutions for developing, as well as for developed countries. As an initial effort to broaden the understanding of how the IP system can be more responsive to public interest considerations, the proponents would like to mention the topic of compulsory licenses.
258. The judicious use of compulsory licences assists countries to uphold the delicate balance of the TRIPS Agreement. While the topic is commonly referenced to with health issues, compulsory licensing can be used in other cases as well. As we all know, neither Article 31 TRIPS nor Article 5A of the Paris Convention contains any restriction with regard to the ground on which a compulsory license may be issued, a view confirmed by the Doha Declaration on TRIPS and Public Health.
259. Under Brazilian law, right holders may be subject to compulsory licences if they exercise patent rights in an abusive manner, or if they engage in abuse of economic power. In the case of dependent patents, for instance, anticompetitive behaviour can be established if the holder of the main patent fails to reach agreement with the patent holder of the dependent patent on the exploitation of the earlier patent.
260. We would like to refer to a concrete case in order to further contribute to the debate. In 2007, Brazil issued its first and only compulsory licence to date, regarding the antiretroviral efavirenz, for public non-commercial use. The underlying intention was to guarantee that HIV patients received appropriate treatment from the Brazilian Public Health System, as efavirenz was used by 40% of all HIV patients in Brazil at the time. Previous to the compulsory license, the Brazilian Government engaged with the patent owner in several meetings with the view of reaching a negotiated solution. Those negotiations, however, did not lead to an agreement in terms and conditions adequate for addressing the public interest.
261. In conjunction with the procedures necessary for the compulsory license, the Brazilian Government initiated the preparation for the production of efavirenz. As we all know, issuing a compulsory license is the initial element of a complex process that involves many actors.
262. The first step was to comprehensively analyse the invention as disclosed in the patent application, clarifying aspects of the phases of production. The disclosure of an invention as mandated by Article 29 of the TRIPS Agreement is an important element of the patent system and could be explored in future discussions under this agenda item.
263. The second step for the public laboratories responsible for manufacturing the medicine was to take advantage of a limitation contained in Article 43, subsection II of the Brazilian Industrial Property Law. The Article states that patent rights do not extend to acts carried out by [unauthorized] third parties for experimental purposes, in connection with scientific or technological studies or researches. It aims at maintaining the incentives for research and studies by third parties, thus allowing the progress of science and technology. Further to those actions, the last step required to initiate the production of the medicine under the compulsory license was to obtain regulatory authorization from the Brazilian health authority, known as ANVISA. To fulfil this requirement, Brazil used another aspect of IP rights, this time related to clinical test data.
264. In spite of strictly following the requirements contained in the national and international legal framework, the Brazilian Government faced legal disputes in national courts, which were initiated by the owner of the patent. These disputes, however, were not successful.
265. As a result of such efforts by the Brazilian Government, and taking full advantage of legally permissible limitations and exceptions, it was possible to substantially reduce the price of efavirenz from US$ 1.59 to US$ 0.45 per tablet at nominal prices. This helped to ensure the adequate provision of medicine to HIV patients who needed to take it on a daily basis to keep the disease under control.
266. Thanks to successful public policies combined with the steady availability of innovative drugs, Brazil is able to provide treatment to the vast majority of patients diagnosed with HIV/AIDS. Nowadays, among those receiving treatment in Brazil, 90% of them have no detectable viral load, a sign of success of the treatment. This result is only possible with the active participation of Government, pharmaceutical companies and patients associations, in line with the higher level goals of the IP system.
267. The recent entry into force of the Protocol Amending the TRIPS Agreement demonstrates the need to have mechanisms that preserve at the same time the adequate remuneration of IP Rights and the rights of governments to adopt measures necessary to protect the public interest. Another recent development of interest is the publication of the United Nations Secretary-General's High Level Panel on Access to Medicines, which contains many recommendations regarding the interplay between intellectual property and access to medicines.
268. Brazil believes that respect for intellectual property and efforts to promote the public interest in sectors of vital importance to a country's socio-economic and technological development are not mutually exclusive. A balanced intellectual property system, with built-in flexibilities as well as complementary policies and incentives, is the best way to incentivize innovation in all fields of technology.
269. We would like to invite other Members to express their views and share their experiences regarding the topic, providing a rich discussion which would be beneficial to all countries and generate additional inputs to the TRIPS Council.
