Submission: AIDS Fond
Prepared by: David Ruiz, Michaël Kensenhuis, and Anne Dankert
Country: Switzerland; Netherlands

Abstract

TRIPS flexibilities are perceived as repairs to a system that is based on protecting patents, rather than providing structural solutions to meet the needs of the poor. Despite the best efforts of civil society, it has been difficult to ‘de-technify’ and re-politicize the debate around Intellectual Property (IP) – taking it out of the hands of international lawyers and pharmaceutical companies and into the hands of developing country governments, social movements and affected communities.

Aids Fonds provides three solutions, focused on barriers related to patents, trade agreements and TRIPS flexibilities

Solution 1: Call on member states to set ambitious and concrete target to promote access to treatment within the outcome document of the High Level Meeting on Aids next June 8-10; by stressing the importance of supporting low and middle-income countries to scale-up access to essential medicines by implementing the flexibilities contained in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement and consistent with the World Trade Organization Declaration on TRIPS and Public Health.

And, provide legal assistance to low and middle income countries to stimulate them to make use of TRIPS-flexibilities.

Solution 2: Call on technical agencies to conduct an analysis of the impact of current Intellectual Property frameworks – including Trade-Related Aspects of Intellectual Property Rights Plus (TRIPS+)provisions in Free Trade Agreements - on the availability, affordability and accessibility of treatment and diagnostics for HIV and co-infections in low and middle-income countries.

Solution 3: Press for ‘fair’ trade agreements and treaties of member states, in which access to affordable and generic medicines for low and middle income countries is guaranteed. High income countries should immediately stop pressuring low-and middle-income countries to adopt or implement TRIPS-Plus measures in trade agreements that impede access to life-saving treatment.

Submission

Background

The recently adopted 2030 Agenda for Sustainable Development includes a strong political commitment to ending AIDS and leaving no one behind. This will contribute enormously to achieve better healthy lives for all and will support the advancement towards other global development goals. Increasing access to affordable and high quality treatment for all people in need is an imperative to ending AIDS.

Anti-retroviral drugs (ARVs) and other medicines, which counteract both effects of HIV and co-infections, make the difference between a healthy life and being ill, a productive life or an early death. Second- and third-line ARVs and medication for co-infections such as hepatitis C or tuberculosis remain expensive or have nasty side-effects in case of Multi-Drug Resistant tuberculosis (MDR-TB). Prices of first-line ARVs have fallen dramatically over the past ten years, primarily due to increased marketplace competition of generic drugs, resulting in having more people in low- and middle-income countries on treatment . In 2015, 15.8 million people were accessing antiretroviral treatment and Aids-related deaths had fallen by 42% since 2004 .

In spite of this remarkable progress, the world is again in the grip of a crisis in treatment affordability and accessibility. According to the new WHO guidelines, as of December 2013, only 37% of all people living with HIV were receiving ART. To further scale-up – doubling the numbers reached - the affordability of ARVs was a critical concern.

Today, every year 1.2 million people still die of AIDS, while life-saving treatment is available. Despite the fact that no one should be left behind towards 2030 and other political commitments made, a major and unacceptable ‘treatment gap’ remains: nearly 21 million people who need treatment do not have access to ARVs , while demand for second and third line ARVs and treatment of co-infections is increasing.

TRIPS flexibilities are perceived as repairs to a system that is based on protecting patents, rather than providing structural solutions to meet the needs of the poor. Despite the best efforts of civil society, it has been difficult to ‘de-technify’ and re-politicize the debate around Intellectual Property (IP) – taking it out of the hands of international lawyers and pharmaceutical companies and into the hands of developing country governments, social movements and affected communities.

Aids Fonds provides three solutions, focused on barriers related to patents, trade agreements and TRIPS flexibilities

Solution 1: promote the use of TRIPS flexibilities by setting ambitious goals on treatment access

All World Trade Organization (WTO) member states agreed on Trade Related Aspect of Intellectual Property Rights (TRIPS) in 1994, protecting the owners of patents, including for medicines. Patents give pharmaceutical companies exclusive rights to market their products and set their price for an (often long) period of time. This permits them to have monopolies and to exclude or delay competition for at least 20 years, including from companies that make lower-cost generic drugs. 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. In 2001, to mitigate the negative impact of IPRs, the WTO adopted the Declaration on TRIPS and Public Health (known as the Doha Declaration). This affirmed that TRIPS “can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all”.

The “flexibility”-measures that governments can take include:

• Compulsory licenses: governments give a license to produce, sell, or import a generic medicine, without the consent of the patent-owner.
• Parallel importing: governments import medicines from countries where these are sold by the patent-holder against lower prices.
• 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.

For example, our partners from International Treatment Prepardness Coalition initiated a patent landscape research, identifying medicines based on inclusion in WHO treatment guidelines, affordability, availability and existing intellectual property barriers blocking access to generic versions. Meetings with decision makers and health care providers were held to inform them about the availability of generic medicines. But also, health ministries were encouraged to issue compulsory licenses or to revoke patents.

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.

Specific attention should be given to ‘pharma-emerging countries’ – those with high burdens of disease, and classified as middle-income (and, therefore, not prioritized by development partners). Such countries are paying exorbitant prices for most ARVs and many are not benefitting from HIV drug access programs provided by originator companies. ARV prices are being negotiated on a case-by-case basis, resulting in higher costs.

Global stakeholders have recognized IP as a barrier to access to medicines, but little
political action has been taken: public health agencies, academics and civil society have increasingly recognized that there are fundamental flaws in the design and application of the current IP frameworks. Also, analyses have found that there is no evidence that implementing TRIPS in developing countries has increased the research and development of drugs or the transfer of technology - as insufficient market incentives are the decisive factor. The claims that IPRs are essential to foreign direct investment, local innovation and economic development are false.

Therefore, Call on member states to set ambitious and concrete target to promote access to treatment within the outcome document of the High Level Meeting on Aids next June 8-10; by stressing the importance of supporting low and middle-income countries to scale-up access to essential medicines by implementing the flexibilities contained in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement and consistent with the World Trade Organization Declaration on TRIPS and Public Health.

And, provide legal assistance to low and middle income countries to stimulate them to make use of TRIPS-flexibilities.

Solution 2: investigate the impact of TRIPS+ provisions on availability, affordability and accessibility of treatment for low and middle income countries

TRIPS+ provisions worsen access to ART and undermine countries’ ability to make full use of TRIPS flexibilities: multilateral organizations and civil society advocates have consistently urged governments to make use of TRIPS flexibilities. However, most developing countries, especially those in Africa, have failed to amend their national legislation. This has provoked civil society campaigns for the reform of IP laws and systems in countries such as South Africa and Uganda. The situation is exacerbated by on-going negotiation of stricter IPRs through bilateral and regional agreements, such as those involving the European Union and the United States. Several low- and middle-income countries have signed or are negotiating Free Trade Agreement (FTAs) with developed countries. These include ‘TRIPS+’ provisions – stricter protections of IPRs that go beyond those required by the WTO. Examples include: the extension of patent terms; the granting of patents on new uses or formulations of existing medicines; and data exclusivity. These limit developing countries’ ability to use TRIPS flexibilities. Numerous studies indicate that TRIPS+ provisions increase the price of medicines or delay price reductions – as they restrict generic competition.

In 2014, Morocco and the EU negotiated a Free Trade Agreement that would possibly include TRIPS plus provisions. Interventions from civil society and a public debate around intellectual property and medicines blocked the negotiations. This stresses the importance of knowledge among stakeholders and NGO’s about TRIPS plus and the impact on access to medicines.

Therefore, Call on technical agencies to conduct an analysis of the impact of current Intellectual Property frameworks – including Trade-Related Aspects of Intellectual Property Rights Plus (TRIPS+)provisions in Free Trade Agreements - on the availability, affordability and accessibility of treatment and diagnostics for HIV and co-infections in low and middle-income countries.

Solution 3: promote generic competition
Generic competition is a key driver for ARV price reduction: The response to HIV has demonstrated that increasing the use of quality-assured generic medicines through competition is a key strategy for reducing prices and therefore improving the affordability and accessibility of medicines. This was made possible because most first-line ARVs were not patented in many developing countries, including India (which has become the leading global producer of generic ARVs). As a result, significant price reductions were achieved. Since 2001, 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.

However, such reductions are less likely to happen for newer ARVs, as well as treatment for HIV co-infections - due to the stricter frameworks now in place to protect IPRs. The number of people that need 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.

Therefore, Press for ‘fair’ trade agreements and treaties of member states, in which access to affordable and generic medicines for low and middle income countries is guaranteed. High income countries should immediately stop pressuring low-and middle-income countries to adopt or implement TRIPS-Plus measures in trade agreements that impede access to life-saving treatment.

Bibliography and References

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Aids by the numbers. World Aids Day – UNAIDS. 2015 http://www.unaids.org/sites/default/files/media_asset/AIDS_by_the_numbers_2015_en.pdf
UNAIDS, Factsheet 2015.
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