Beat the AIDS epidemic Press for fair prices and better access to medicines.

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1 Beat the AIDS epidemic Press for fair prices and better access to medicines. JUNE 2015 Globally, 35 million people are living with HIV. 22 million of them do not receive the treatment they need. The patent system forms an important barrier to access to HIV drugs, because it leads to unnecessary high prizes set by pharmaceutical companies. Today, at this defining point in the fight against AIDS, Aids Fonds and Artsen zonder Grenzen press for better access to medicines by fixing the current patent system.

2 Aids Fonds, Artsen zonder Grenzen and over 7,500 people call upon the Dutch Minister for Foreign Trade and Development to: Put ending the negative effects of the current patent system on access to medication for people living with HIV on the agenda during the Dutch EU Presidency in 2016; Press for fair trade agreements and treaties of the Netherlands and the EU, in which access to affordable and generic medicines for low- and middle-income countries is guaranteed; Provide legal assistance to low- and middle-income countries to stimulate them to make use of TRIPS-flexibilities; Take a leading role in exploring an alternative model for the development of new medicines, that stimulates pharmaceutical innovation but prevents patents and high prices, in close cooperation with the Dutch Minister of Health, Welfare and Sport.

3 What is wrong with the current patent system? HIV medication (ART 1 ) can like products, services, ideas or knowledge be patented, as they are the result of research and innovation. The basic framework for patent regulations (what can be patented, for how long and under what conditions) is set by the World Trade Organization (WTO). All WTO member states agreed on TRIPS 2 in 1994, protecting the owners of patents, including medicines. The TRIPS agreement obliges each WTO member country to grant at least a 20-year patent on new products. This minimum of 20 years of patent protection applies to all processes and products and does not distinct whether or not the products are life-saving medicines or luxury items. Medicines particularly newer medicines needed for second and third line HIV treatment 3 are expensive because of strong intellectual property protections that result in high prizes. However, in some circumstances, (developing) countries have the possibility to legally circumvent patents and import or produce cheap, generic medicines 4, the so-called TRIPS-flexibilities, enforced in the Doha declaration in This 2001 Declaration states that the patent regime should protect public health and promote access to medicines for everyone. The flexibility -measures that governments can take include: l Compulsory licenses: governments give a license to produce, sell, or import a generic medicine, without the consent of the patent owner. l Parallel importing: governments import medicines from countries where these are sold by the patent holder against lower prices. l Patent opposition: governments refuse to grant a patent, including for lack of novelty, or to revoke a patent. As a result, generic medicines are allowed on the market. But countries that have attempted to bring down the prices of medicines have come under economic and political pressure from richer countries and the pharmaceutical industry. While the global community has repeatedly made commitments to secure affordable medicines for all, this promise runs counter to the prevailing economic and trade interests that view medicines as investments and commodities from which to extract maximum profit. The importance of generic antiretroviral drugs. Since 2001, global political mobilization cleared the way for competitive production of generic versions of widely patented medicines. Thanks to this generic competition, prices for antiretroviral treatment were drastically reduced from 7,500 per year for a patented combination of antiretroviral drugs in 2001, to 60 a year for a generic combination nowadays. This meant being able to put 13 million people on treatment in low- and middle-income countries in the past 15 years. However, this same success is now under threat, asking for new global political mobilization.

4 The number of people that needs access to newer, patented and therefore more expensive HIV-drugs is progressively increasing (e.g. because regimens to treat HIV are changing to more effective and less toxic drugs, or because the number of people that do not respond to first-line regimes is increasing). However, most low- and middle-income countries are not able to pay for these drugs, leaving patients with no or sub-optimal treatment. New bilateral trade agreements e.g. between the EU and low or middle income countries often include provisions that forbid the use of TRIPSflexibilities (so-called TRIPS-plus provisions), prohibiting the use of generics. Today, every year 1.5 million people still die of AIDS, while life-saving treatment is available: many countries cannot afford the HIV treatment for people living with HIV; TRIPS-plus provisions in trade agreements undermine access to affordable medicines; in some (middle income) countries, health budgets are spent on medicine purchase only; people living with HIV are more vulnerable to other diseases, such as tuberculosis and hepatitis. TB is the leading cause of death of people living with HIV. Even when countries are able to afford buying the needed medicines, effects are severe as the prices of medication are higher than they should be, and the limited budget of these countries cannot be spent on other parts of the health sector. We are at a pivotal point in the global fight against AIDS. If we want to beat AIDS, we need to fix the patent system. The human impact of this lack of flexibility in the patent system. In Morocco, the cost of third-line raltegravir, darunavir and etravirine represents 13% of the total HIV-medicines budget allocated by the department of health and the Global Fund. However, this treatment regime is used by only 0.2% of people living with HIV on treatment (only 11 people!). India is known as the developing country pharmacy. It has played a crucial role in the development of the generic drug industry. It is estimated that more than 90% of the global supply of HIV drugs come from India. However, India must now abide the TRIPS agreements and must grant 20-year exclusivity to drugs that are considered to be the inventions of pharmaceutical players. Fortunately, India s patent law is still quite strict on granting patents. Only real inventions can be patented, leaving room for the production of many generic HIV medicines. But this situation is likely to change as a result of current free trade treaty negotiations. The EU has been negotiating with India globally the largest producer of affordable and generic medicines about a free trade treaty. There are concerns that this new agreement will obstruct India to continue its role as pharmacy of the world. Current agreements are under negotiation with Brazil, Thailand, and the Philippines.

5 How can you fix the patent system and make life-saving medicines accessible for all people living with HIV? There are proven solutions to guarantee universal access to drugs not only to those who live in the poorest countries. These solutions focus on generic competition, such as compulsory licensing and patent opposition. We need expanded use of these existing flexibilities in patent law, especially for low- and middle-income countries, to lower medicine prices and to increase access to treatment. Moreover, we need to work towards alternative models that not only guarantee access to existing medicines, but that stimulates real medical innovation that is highly needed to develop new treatments for HIV and tuberculosis. Aids Fonds, Artsen zonder Grenzen, 7,500 people in the Netherlands and millions of people worldwide ask you to: Put ending the negative effects of the current patent system on access to medication for people living with HIV on the agenda during the Dutch EU Presidency in 2016; Press for fair trade agreements and treaties of the Netherlands and the EU, in which access to affordable and generic medicines for low- and middle-income countries is guaranteed; Provide legal assistance to low- and middle-income countries to stimulate them to make use of TRIPS-flexibilities; Take a leading role in exploring an alternative model for the development of new medicines, that stimulates pharmaceutical innovation but prevents patents and high prices, in close cooperation with the Dutch Minister of Health, Welfare and Sport. Beat the AIDS epidemic and fix the patent system! 1 Antiretroviral Treatment 2 TRIPS: Trade Related Aspects of Intellectual Property Rights an agreement between members of the World Trade Organization about intellectual property. 3 HIV is a virus that easily develops resistance against antiretroviral treatment. If this happens, the medicines the patient started with (first line) are not effective any more, and the patient has to switch to another combination of drugs, called second line. If this regimen fails as well, a third line combination has to be prescribed. In general, medicines used in second and third line combinations are newer, patented drugs, and therefore much more expensive. 4 A generic drug is a pharmaceutical product, completely interchangeable with a branded product, but manufactured without a license from the innovator company. Generic drugs normally costs a fraction of the price of the branded product. Generics should not be confused with counterfeit medicine: drugs that are deliberately and fraudulently mislabeled with respect to identity and/or source. Sources: Londeix, P. (2014). Supply and demand: Why drug prices and trade barriers are blocking drug access and what activist scan do about it. Extract from AIDS Today: Tell no lies, claim no easy victories (2014) published by the International HIV/AIDS Alliance. Zaidi, S. Access challenges for HIV treatment among People Living with HIV and Key Populations in Middle-Income Countries. Policy brief, October t Hoen, E et al (2011). Driving a decade of change HIV/ AIDS, patents and access to medicines for all. Journal of the International AIDS Society. Dey, S. (2015). Fears over EU plan for strict drug patent regime. India Times, 14 April 2015.

6 Organizations that support this petition: Netherlands Aids Foundation East-West Amref flying doctors Choice COC Cordaid dance4life GNP+ Hiv Vereniging Nederland ICCO Coöperatie International Civil Society Support KNCV Tuberculosis Foundation Mainline Nederlandse Vereniging van Hiv behandelaren Rutgers Simavi STOP AIDS NOW! TAMPEP Wemos International AGIHAS (LAT) AIDS Action Europe (GER) Aids Hilfe Wien (AUS) AIDS-Support (SER) ARAS (ROM) ArchImeDeS (CZE) Demetra (LIT) ECUO (ROM) European AIDS Treatment Group (BEL) HOPS (MAC) Medico-Psychotherapeutic Center Labyrinth (KOS) National AIDS Trust (UK) International HIV/AIDS Alliance (UK) LILA (ITA) Projecte dels NOMS-Hispanosida (SPA) Sensoa (BEL) SKUC (SLO) UNAIDS Acknowledgements Michaël Kensenhuis, Jorrit Kabel, Anne Dankert, Katrien Coppens, Lucia Broms For more information please contact Michaël Kensenhuis at Aids Fonds:

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