SS+Uganda+PIC



A. Unique-link: Uganda can reject IPR portions of EU’s trade agreement now but increased aid pressures them to curtail their own property rights. Tetteh Hormeku, TWN-Africa, 2-05 (Third World Network-Africa, Volume 2 Number 2, African Trade Agenda, 'Data Exclusivity' “Focus on EPAs,” “How The Eu Could Use Epas To Undermine Access To Affordable Medicines,” www.twnafrica.org/docs/ATA-22-en.rtf [T Chenoweth]) In the EPA negotiations so far, neither side (the EU nor the ACP group as whole nor the regions) have referred directly to 'data exclusivity'. Indeed, in the European Union's negotiating mandate, the only reference to "data protection" is to the "elimination of free movement of personal data between parties created by the lack of protection of personal data.'' At the same time, however, the European Union mandate makes it clear that the EPAs "will confirm the respective commitments undertaken in the framework of the Cotonou Agreement", in articles 45 to 51 and 78, including commitments on intellectual property rights. Article 46 of the Cotonou Agreement defines intellectual property rights to include, among others, the "legal protection of data bases and the protection against unfair competition as referred to in Article 10a of the Paris Convention … and protection of undisclosed confidential information on know how." Article 10a of the Paris Convention as referred to in the Cotonou Agreement says nothing about unfair competition or protection of undisclosed information. The reference to unfair competition is article 10bis of the convention. Even this article does not contain reference to data bases or undisclosed confidential information. Indeed the language of the Cotonou agreement takes up from the provisions of article 39 of the WTO's TRIPS Agreement which is devoted to providing effective protection against unfair competition as referred to in article 10bis of the Paris Convention. Data protection, as covered under 39.3 of the TRIPS agreement, is limited to precise conditions, and does not include 'data exclusivity'. However, under pressure from their big pharmaceutical companies, the EU and the US have been insisting that data exclusivity is mandated under the TRIPS. This has been rejected by developing countries, supported by many experts. The language of the Cotonou Agreement replaces the precise formulations of the TRIPS agreement with loose and flexible ones which are then loosely re-attributed to the Paris Convention. This is probably not accidental, in the light of the great controversy generated in the course of the negotiations of the intellectual property provisions of the Cotonou agreement. However, the loose formula of the Convention opens up the opportunity for the EU to re-introduce its demands on 'data exclusivity' within the IPR negotiations under the EPAs. Statements by the EU in different fora since the Cotonou Agreement are instructive in this regard. One such occasion was a paper submitted by the EU in the WTO, a year after the Cotonou agreement and in the run-up to the Doha ministerial. This was in response to submissions by African countries on TRIPS and public health. In that paper, the EC insisted on its interpretation of the TRIPS agreement as requiring 'data exclusivity', whether the product in question is "protected by patent or not". Even though it was aware that this could undermine the effectiveness of emergency safeguard such as the issue of compulsory licence, the EU offered little comfort to the African countries, apart from ambiguous assurances, and a "readiness to discuss to what extent technical assistance can take into account health concerns". Technical assistance could prove an additional weak point for ACP countries in the struggle that is likely to emerge over this and other issues when the intellectual property provisions of the EPAs come to be negotiated. For instance, in an otherwise balanced paper on the options for the intellectual property in the EPAs prepared for the Eastern and Southern African (ESA) bloc, the COMESA secretariat announced an intention to hold a workshop to determine a plan of action on TRIPS and Access to medicines that is most beneficial to ESA and COMESA countries. But it added that "the plan of action should take into account recent trends in the reduction in costs of medicines for HIV/AIDS, malaria and TB, as well the initiatives of some donors to assist poorer countries procure medicines at subsidised prices or using donor funds". Such initiatives by donors to assist poorer countries in Africa so far have been accompanied by pressures on these countries to abandon their rights under the TRIPS agreement and the flexibilities of the Doha declaration, and instead get them to adopt more restrictive national laws in relation to intellectual property. Hopefully, ACP countries and their negotiators will not allow themselves to be seduced by technical assistance or pressured into allowing in 'data exclusivity' through the EPAs. The language contained in the Cotonou Agreement is not a conclusive statement of a specific obligation by which the EU can hold ACP countries. These countries are within their legal and moral rights, both within the WTO and the Cotonou Agreement, to reject 'data exclusivity' in the EPAs.

B. Failure to negotiate on the EPA allows the EU to force data exclusivity property rights on Uganda, destroying its ability to get drugs to fight AIDS and turning the case. SEATINI, Southern and Eastern African Trade Information and Negotiations Institute: Strengthening Africa in Word Trade, 8-24-05 (“A Study on the Technical Issues in the 6 Negotiating Clusters under the ESA-EU EPA Negotiations,” Chapter 8.1.2 – Intellectual Property Rights, p. 77-80 found at: http://www.epawatch.net/general/text.php?itemID=298&menuID=6 Acc: 7-26-07 [T Chenoweth]) Article 46 of the Cotonou Agreement states the agreement of the Parties to their commitments under the TRIPS Agreement. Any further mention of the TRIPS Agreement and intellectual property rights generally, must appropriately emphasize the issues of priority to Africa and other developing countries that they have put on the international agenda with some success. Data Exclusivity ESA countries and other ACP countries face a **'hidden' threat** to their ability to access affordable medicines for a wide range of diseases like malaria and HIV/AIDS. Judging from recent EU attempts in the context of other bilateral trade discussions, and from the language in the intellectual property provisions in the Cotonou Agreement, the ACP countries could end up saddled with the EU's laws on 'data exclusivity'. 'Data exclusivity' refers to a peculiar type of 'intellectual property protection' by which EU member countries, like their US cousin, grant exclusive marketing rights to pharmaceutical companies even in relation to medicines that are **not** under patent protection, and sometimes even when there has been no new invention. The effect is to further disable generic competitors from supplying such drugs at more affordable prices, thereby enabling big pharmaceuticals companies to continue to charge monopoly prices. A new and even more stringent version of this is due to come into force throughout the European Union in November, this year. This is not only beyond the provisions of the World Trade Organisation's TRIPS agreement. It also flies directly in the face of the flexibilities for developing countries contained in the Doha declaration on TRIPS and public health. Nevertheless, the US has already inserted such provisions in its bilateral Free Trade Agreements with several countries, including Morocco. The EU is poised to do the same. 'Data exclusivity' arises in the following context. Before drug manufacturers are allowed to put a new drug on the market, they are required to submit test data on the drug's safety and efficacy to the regulatory authorities – data generated from extensive research and clinical trials. Such data is protected through separate legal instruments that differ from country to country. In most countries including African countries like Ghana and South Africa, the authorities protect the data against disclosure to a third party. However, the authorities can rely on the data to give marketing approval to a similar drug by a company other than the originator of the test data -- say a generic manufacturer -- provided that the later drug is proven to be similar in clinical function to the one already on the market. 'Data exclusivity' prevents this. Under current EU laws, once a company has submitted original test data, no competing manufacturer is allowed to rely on these data to request for marketing approval of its own drug for periods of 6 or 10 years (depending upon the EU member-country). If such 'data exclusivity' provisions find their way into the EPAs, generic manufacturers would not be able to place versions of known drugs on an African market unless they compile their own test data. Such a process could take several years and may be prohibitively expensive. Thus, an African country which exercises its rights under the Doha declaration to issue a compulsory licence for the supply of cheaper drugs, may find that there is nobody to supply the drugs. Data protection, as covered under Article 39.3 of the TRIPS agreement, is limited to precise conditions, and does not include 'data exclusivity'. However, under pressure from their big pharmaceutical companies, the EU and the US have been insisting that data exclusivity is mandated under the TRIPS. This has been rejected by developing countries, supported by many experts. ESA countries together with other ACP countries and their negotiators should not allow themselves to be seduced by technical assistance or pressured into allowing in 'data exclusivity' through the EPAs. The language contained in the Cotonou Agreement is not a conclusive statement of a specific obligation by which the EU can hold ACP countries. These countries are within their legal and moral rights, both within the WTO and the Cotonou Agreement, to reject 'data exclusivity' in the EPAs.

And, unchecked AIDS threatens extinction of humankind. Susan Hunter, 2003, an independent consultant to certain agencies of the United Nations (WHO, UNAIDS, UNICEF), BLACK DEATH: AIDS IN AFRICA, p. 9 By taking a closer, more reasoned look at why Africa has failed to develop as a continent, we can understand the future of AIDS on other continents. Africa is only the worst case of an inhumane scenario being played out in other regions of the world to the detriment of the human species as a whole. The growing wealth of developed countries over the past two centuries and the growing impoverishment of developing regions are inescapably related. The deprivation that limits the lives of one in every five human beings on the planet creates a burden of moral responsibility not only to give back, but to think about a strategy that yields a safer and saner world for the children of every country in the twenty-first century. As HIV/AIDS and other epidemic diseases increase, they are creating a huge disease reservoir that threatens the very existence of humankind. One of the most important evolutionary relationships is between humans and their microbes, and many scientists feel that because of fundamental neglect of the needs of 20 percent of the human race, the microbes are winning.