Brussels, 9 April, 2013 –

“In the wake of several recent pro-public health decisions in India, the EU is now doubly keen to shut down India as the ‘pharmacy to the developing world’ and ensure the profits of its pharmaceutical companies are kept intact”, said Leïla Bodeux of Oxfam. “Eighty per cent of medicines used to treat HIV in the developing world come from India, and if the EU succeeds in retaining the harmful provisions that remain in the agreement, it would cut off this lifeline supply for millions of people.”

Under pressure from public health groups, certain provisions damaging to access to medicines such as patent term extensions have been removed from the proposed deal. However, the intellectual property (IP) enforcement and investment provisions are still seriously concerning, particularly as an early April deadline to sign the agreement is imminent.

“This attack on the health of the world’s poorest is seriously concerning, particularly as a deadline to sign the agreement draws ever nearer and could be days away”, said Carl Schlyter, MEP for the Green Party. “The EC cannot claim it supports access to medicines and is concerned about the lives of people in developing countries, and in the same breath be pushing harsh provisions around intellectual property enforcement on India.”

“I’m urging the European parliament: don’t accept the provisions that will impact so many lives before you sign on the dotted line.”

Dressed as zombies, wearing ripped and bloody suits representing European trade negotiators, the campaigners from organisations including Oxfam, Médecins Sans Frontières (MSF), the Stop AIDS Campaign, Health Action International (HAI) Europe and Act-Up Paris protested outside the European Parliament alongside concerned MEPs.

“Some FTA harmful provisions are similar to ACTA, an anti-counterfeiting deal which was killed off thanks to intense public scrutiny. But now they are back: this is the issue that just never dies,” said Lotti Rutter from the Stop AIDS Campaign.

Enforcement provisions could potentially block the production and export of generic medicines from India – a lifeline for millions of people across the developing world. Enforcement provisions would open the door to abusive practices from multinational corporations, by allowing medicines to be delayed, seized, detained and destroyed.

Measures on investment could see the Indian government – as well as third parties like treatment providers such as MSF – sued by multinational companies for billions of dollars in private arbitration panels if national laws, policies, court decisions or other actions are perceived to interfere with their investments – for example, if an Indian patent office rejects or overrides a patent on a medicine to increase access.

“As treatment providers, we are alarmed about the impact of these measures if they go through. Not only will they put another nail in the coffin of access to the affordable, quality medicines MSF relies on to treat patients across the world, but we could be at-risk of being embroiled in disputes for simply using generic medicines. Europe should drop all demands that threaten public health in all their trade negotiations,” said Katy Athersuch, MSF Access Campaign.

The anticipated conclusion of the EU-India FTA in early April has sparked protests across Asia, Europe and Africa – the continent that could stand to lose the most from an agreement.

This FTA is just the latest in a long line of negotiations by the EU to impose stricter IP provisions on developing countries; The EU is currently in FTA negotiations with India, ASEAN, Malaysia and Ukraine, and is planning negotiations with Thailand, Morocco, Tunisia and Egypt, among others.

“We are extremely worried; in our region, people living with HIV are benefitting from generic antiretroviral medicines imported from India”, said Othman Mellouk from the International Treatment Preparedness Coalition in the Middle East and North Africa. “Such an agreement between India and Europe will have harmful consequences and prevent the access to essential medicines in our region, and we call on the European Commission to stop its trade policy that only benefits pharmaceutical companies and negatively affects people in developing countries”.

The Stop AIDS Campaign and Student Stop AIDS Campaign have campaigned extensively to stop Novartis’ ruthless pursuit of patents over patients, urging the defeat of this seven-year court case.

The case threatened a key provision in India’s pro-public health patent law, which prevents so-called ‘evergreening’ – where pharmaceutical manufacturers seek new patents for slightly modified versions of an existing drug, and thereby gain an extension of their monopoly on this medicine by an additional 20 years if patents are granted.

That the Indian Supreme Court rejected the request for this patent on Glivec, means the provision in India’s patent law which prevents this shameless extension of monopolies, has not been weakened or undermined. With over 80% of affordable generic medicines in the developing world produced in India, the decision is critical in ensuring the supply of generic HIV treatment, and other medicines, is not strangled in the future.

Chair of the All-Party Parliamentary Group on HIV/AIDS, Pamela Nash MP had the following to say on the landmark decision:

“The decision today will help to ensure that the rights of poor people in developing countries to access essential medicines are protected. It is now critical that India’s ability to produce affordable life-saving drugs for people living with HIV and other diseases is not undermined by the Free Trade Agreement currently being negotiated with the EU.”

As the Rt. Hon. Pamela Nash rightly highlights, there remains much work to be done in the face of continued threats to the supply of affordable generic medicines from India, including those used to treat HIV. Watch this space for updates on our fight against Free Trade Agreements in the coming weeks, including our Twitter action next Thursday and Friday.

But for today, we can rightly pause and celebrate such an historic victory. Thanks to all our campaigners, who have donned murder mystery garb, and protested in locations as varied as Novartis plants, Washington DC and the Swiss embassy, joining campaigners all over the world in helping secure this historic, and vitally important, decision.

The film is being toured by RESULTS, an international NGO that uses advocacy and campaigning to bring about the end of extreme poverty. The film’s title is relevant to the TB epidemic as a whole. 1.4 million people died of TB in 2011 – a completely unacceptable mortality rate for a preventable and curable disease – and it remains the leading cause of death in people living with HIV worldwide. At least a third of all people living with HIV in the world are co-infected with TB. Multi-drug resistant TB (where TB cannot be treated by first-line drugs) is on the rise, with 310,000 new cases in 2011, and extensively-drug resistant TB (where TB cannot be treated even by second-line drugs, making it sometimes impossible to treat), has been identified in 84 countries.

The World Health Organisation and the Global Fund to Fight AIDS, TB and malaria, this week said there is an urgent need for $1.6 billion per year of international financing for TB programmes, in order to see full treatment and prevention of the disease. The Global Fund itself provides 90% of all international financing for the TB response: without a fully funded Global Fund, the response to TB would be completely decimated. You can learn more about some of the lives the Global Fund’s TB funding impacts on in this video.

In addition, for the Global Fund, this year is of critical importance. The Fund’s replenishment process – whereby new finances are raised for its vital work – will be launched in April. If the funding gap of $1.6 billion can be filled, 6 million lives could be saved between 2014-16, through the provision of TB treatment for 17 million people. Without this financing now, the epidemic will continue to grow, and people living with HIV and TB, and affected by malaria, will only continue to go home to die.

For more information on ‘They Go to Die’ screenings, and to help RESULTS UK hold mining companies to account for the provision of TB treatment and care for their miners, please contact felix.jakens@results.org.uk , or click here.

By

Steve Lewis, Global Health Advocacy Manager, Results UK
Jessica Hamer, UK Consortium on AIDS and International Development
Tom Warren, , UK Consortium on AIDS and International Development

We are a network of 80 UK agencies which includes many of the world’s leading development agencies. Based in the UK, with strong links to governments, international and multilateral agencies, we have been working at the forefront of the response to HIV and AIDS since 1986.

The organisation finalises its 2013-16 strategy this March. As well as providing a clear direction for our work going forward, the new strategy will involve a re-branding exercise designed to simplify our appeal to donors and supporters and a re-structuring of the staff team. This new post of Trusts Fundraising and Communications Officer has been identified as essential going forward.

The successful candidate will work closely with the Director and other members of the staff team, all of whom will have fundraising responsibilities. S/He must be comfortable with the pressures, and enjoy the variety of, working for a small but busy office.

The position is subject to a six-month probation period.

We welcome applications from qualified people living with HIV.

Download the job description and person specification, equal opportunities monitoring form and application Form.

If you would like to discuss this role, please email info@aidsconsortium.org.uk providing a contact number.

Salary: £24,276.73 (including London weighting), plus 6% pension contribution

Hours: 35 hours per week

Reports to: Director

Based at: Grayston Centre, 28 Charles Square, London N1 6HT

Closing date: 3^rd April 2013

Interviews: Week commencing the 16^th April 2013

While the EU noted its willingness to consider an extension of the LDC transition period, it did not support an unlimited time-frame for this. In the EU’s view, their most important concern with the LDC request was that they felt it lacked “both a clear and predictable perspective and it remains silent on how IP and the TRIPS Agreement could specifically help LDCs in building a viable technological base”. You can view the full EU statement from this meeting here.

We must keep up the pressure to ensure that this request is granted – watch this space for further campaign actions. Read on to hear the Ambassador of Nepal’s powerful intervention on behalf of the LDC Group stating the case for why LDCs need this essential flexibility…

Mr. Chairman,

As you explained, LDCs’ request for an extension of the transitional period under Article 66.1 of the TRIPS Agreement, contained in the document IP/C/W/583, was introduced on behalf of LDCs Group to the last TRIPS Council. Today, I intend to present the request with details.

LDCs communication containing the duly motivated request of November 5, 2012 is self-explanatory. It contains an annexed draft decision and provides the rationale behind our request. We seek the decision that the LDCs shall not be required to apply the provisions of the Agreement, other than Articles 3, 4 and 5, until they cease to be an LDC.

Mr. Chairman,

An important flexibility available to LDCs under the TRIPS Agreement is the transition period that is extendable. This flexibility was granted to LDCs in recognition of their special needs and requirements, their economic, financial and administrative constraints and their need for flexibility to create sound and viable technological base. While the initial 10 year transition period was to expire at the end of 2005, TRIPS Council approved in 2005 an extension of the period, which will expire on July 1, 2013. LDCs now submit a duly motivated request that the transition period be extended further.

LDCs need the continuation of flexibility as their situation has not changed significantly over the years. Their marginalization continues. They have not been able to develop their productive capacities which limit their meaningful integration into the world economy.

LDCs continue to be characterized by multiple structural constraints that include low per capita income, low level of human development and extreme vulnerabilities to external shocks. LDCs are home to more than 50 per cent of over a billion people who live in extreme poverty. These countries are the most off-track in the achievement of the internationally agreed development goals, including the Millennium Development Goals. They bear considerable health burdens – of both communicable and non-communicable diseases. In 2011, according to UNAIDS, some 9.7 million of the 34 million people living with HIV worldwide lived in the LDCs. Of these people, only 2.5 million had access to antiretroviral treatment.

LDCs’ economic indicators have not changed since 2005. Trade in goods and services has not improved much– in fact trade deficit in both goods and services have increased; per capita GDP growth has fallen.

All LDCs are net payers of royalties. These countries have not been able to spend even a small fraction of their national budget to research and development as they have to concentrate more on basics like health and education. The developmental schemes for transfer of technology provided in TRIPS Article 66.2 have not effectively and adequately materialized.

The level of technological development in the LDCs has remained low. In UNDP’s Technological Achievement Index LDCs are at the bottom. So are they in UNIDO’s Competitive Industrial Performance Index and UNCTAD’s Innovation Capability Index. Numbers from WIPO reports indicate that LDCs have not been able to enter the race of technology and innovation.

In Istanbul Programme of Action we all recognised that LDCs are lagging behind in the critical areas of science, technology and innovation. Unless LDCs have flexibilities to adopt policies to stimulate technological catch-up with the rest of the world, they will continue to fall behind other countries and face deepening marginalization.

In terms of future outlook, the 2012 UNCTAD LDCs report, has noted that “LDCs have to prepare for a relatively prolonged period of uncertainty, with possible escalation of financial tensions and real economic downturn”.

The flexibility agreed in TRIPS Article 66.1 is in consideration of LDCs’ special situation and it is not possible to predict when LDCs will be able to overcome this. It has been recognized in the preambular paragraph that least developed countries have “special needs” and thus need “maximum flexibility in the domestic implementation of laws and regulations in order to enable them to create a sound and viable technological base” LDCs view that the most logical and predictable approach is not to set an artificial timeframe. Our proposed approach gives more certainty and predictability – once you graduate, you need to comply. We find precedence of such exemption in Article 15(2) of the Agreement on Agriculture.

LDCs’ request has been motivated by the need of policy space to (to quote UNDP’s latest issue brief) ‘conserve the autonomy to determine appropriate development, innovation, and technological promotion polices, according to local circumstances and priorities’. They need such space to ensure access to various technologies, educational resources, medicines and tools necessary for development. Most IP-protected goods and services are simply beyond the purchasing power of least developed countries and their people. To quote UNAIDS Executive Director Michel Sidibe, ‘An extension would allow the world’s poorest nations to ensure sustained access to medicines, build up viable technology bases, and manufacture or import the medicines they need’.

TRIPS Article 66.1 specifies an obligation to grant extensions once the TRIPS Council receives a duly motivated request from LDCs. Ministers have invited us ‘to give full consideration’ to a duly motivated extension request from LDCs. Paragraph 2(iii) of the Uruguay Round Decision on Measures in Favour of LDCs specifies that ‘sympathetic consideration shall be given to specific and motivated concerns raised by the least-developed countries in the appropriate Councils and Committees’.

While I present the LDCs proposal, I recall the statement UN Secretary General Ban Ki-moon made back in 2007 at the opening of ECOSOC session (quote-unquote) “The rules of intellectual property rights need to be reformed, so as to strengthen technological progress and to ensure that the poor have better access to new technologies and products”. What LDCs are seeking today does not go to the extent of reform of IPR. We are simply asking for the continuation of flexibility already agreed in 1995 – with reasons.

Mr. Chairman,

Before I conclude, I take this opportunity to extend the LDCs Group’s thanks to you for your constructive efforts to bring us all together on the issue. I thank Members for their interests in LDCs Proposal. We have already had a couple of rounds of informal consultations with Members, including the one the Chair facilitated. We are encouraged to note the positive engagements.

We would also like to highlight that the LDC request and draft decision text have received strong support from the UN development agencies, civil society as well as from industry.

Today, we request Members to extend support to the LDCs’ request, which is duly motivated and to adopt the draft decision contained in the annex of the document no IP/C/W/583.

Thank you.

Yesterday the EU and Thailand announced the launch of talks to negotiate a free trade agreement (FTA). Across the globe, trade negotiations are taking place which seek to increase the privileges of the pharmaceutical industry whilst fatally undermining access to affordable medicines for the world’s poor – and the Thai negotiations look set to be no different. These ‘closed door’ negotiations aggressively push for stronger industry control at the expense of public health, threatening millions of people’s lives.

Last week thousands of protesters from 28 civic groups gathered in Bangkok to warn the government against entering these negotiations. They ‘are worried the talks could make medicine for serious diseases more expensive’ – a consequence of introducing TRIPS plus measures such as patent term extensions and data exclusivity. Even industry admit this effect stating ‘introducing these “TRIPS-plus provisions” may be tough as they will reduce the availability of generic medicines, thus raising drug prices and undermining access to affordable, quality treatment for millions of people across the developing world.’

We stand in solidarity with the Thai activists!

PARLIAMENTARY BRIEFING PACK HERE

In 1995, the World Trade Organisation established the agreement on Trade related aspects of Intellectual Property Rights (TRIPS) that set the minimum standards for intellectual property protection in the world. TRIPS states that if you come up with a new invention you can patent it, so no-one can copy it for 20 years.

That’s a 20 year monopoly.

The idea is to protect the people who’ve invested in coming up with new ideas. That might sound reasonable but TRIPS applies to medicines too. And that means that if you come up with a life-saving HIV drug you can charge whatever price you like, as there’s no competition to bring the price down. This meant that when the first generation of HIV medicines were developed the initial costs were up to US$10,000 per patient per year, far more than any poor countries could afford.

People realised that the impact TRIPS was having on access to treatment around the world was grossly unfair, and moved to try and reduce the harmful effects – what they came up with became known as TRIPS flexibilities. One flexibility was to prolong the time at which the poorest countries would have to adopt these rules. Specifically extending the deadline that the Least Developed Countries (LDCs) in the world had to enforce TRIPS from 2006 to 2016. This deadline needs to be further extended now or they will face the same difficulties that other developing countries already contend with in accessing medicines.

Last November, Haiti on behalf of all the LDCs, submitted a request to the TRIPS Council that this deadline be extended until the point at which these countries cease to be LDCs. This request is being considered an upcoming meeting to be held from 5^th – 6^th March 2013. The problem is that some richer countries are opposing this request even though they are obliged to allow it. 

That’s why we need your help.

We want you to write to your MPs and MEPs to ask them to ensure that the UK Government and European Commission do all in their power to protect access to medicines within the Least Developed Countries (LDCs) of the world. It couldn’t be easier.

1. Find links to template letters to send to your MP and MEPs, or write your own.

2. Find out who your MP is at www.theyworkforyou.com

3. You can find out who your MEPs are by region here (you have several MEPs!)

4. Email your MP and MEPs linking to this page so that they can download our parliamentary pack at the top, which includes a template letter for them to send to Ministers/Trade General and a full parliamentary briefing.

5. You can find some top tips for lobbying politicians in our activist guide here.

If you have any other questions or if you get any replies please get in touch with lotti@aidsconsortium.org.uk 

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Joint letter on the occasion of the 132nd session of the WHO Executive Board: Agenda item 10.2 - Follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination 25 January 2013

Distinguished delegate,

We are writing to express our deep concern at the lack of ambition and apparent inaction of the WHO and Member States in taking forward the work of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG). This inaction is costing lives.

 
At the open-ended meeting (26-28 November 2012) on the follow-up of the report of the CEWG, an outcome document (EB132/21) containing a draft report and draft resolution was produced. The draft report and draft resolution are now before the Executive Board for consideration under Agenda item 10.2. The open-ended meeting was convened to provide Member States with the opportunity to develop a work plan for taking forward the recommendations of the CEWG report. This report was part of the implementation of the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA). The objective of which is to secure “an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries”. The CEWG identified the concept of de-linkage as the over-arching principle in which to secure this objective by de-coupling the cost of R&D from the price of health technologies including medicines, vaccines and diagnostic tools. The central recommendation of the CEWG report that Member States were asked to consider was the development of a legally binding global convention to address the unmet R&D needs of developing countries.

Such a global framework is needed to establish a process for identifying R&D needs, setting priorities, monitoring R&D flows, coordinating R&D efforts, securing sustainable financing, promoting new incentives and managing research outputs in a way that ensures both innovation and access. Given the WHO’s role(1) as the directing and co-ordinating authority in global public health, it is uniquely placed to be the forum for such an instrument.

Despite the clear roadmap set out by the Expert Group, the outcome document produced at the open ended meeting postpones discussion of an R&D Convention at the WHO, and does not provide a clear agenda for addressing these pressing unmet R&D needs. The commitments that are made are unclear and too limited. For example, the establishment of an R&D Observatory could be a positive first step, but only if the scope of its tasks includes the definition of R&D priorities in consultation with Member States in addition to simply monitoring what little is currently being done. The question of whether this R&D observatory will receive adequate financing to operate effectively is also an unanswered question.

 
Moreover, we are seriously concerned that the draft report’s recommends, “the adoption of the resolution by the WHA without re-opening it”. The report and the draft resolution were adopted after 2AM, when many lead negotiators had to fly back to their respective capitals and interpretation in the World Health Organization’s official languages had long stopped. The number of Member States present at the time of finalizing the draft report was less than 25 out of a membership of 194. A draft resolution negotiated by a small number of Member States under less than ideal conditions should not include such a far-reaching recommendation to the Executive Board. This undermines the rights of Member States to have a full discussion at the WHA.

Against this background we ask the distinguished EB Members and other WHO Member States to reject the recommendation against the reopening of the draft report and the resolution.

Further, we request WHO Member States to consider the CEWG recommendations holistically including the central recommendation of the CEWG report which recommended to Member States that “formal intergovernmental negotiations should begin for a binding global instrument for R&D and innovation for health”.

Health Action International
Knowledge Ecology International
Médecins Sans Frontières- Access Campaign
Oxfam
Peoples’ Health Movement
Stop AIDS Campaign
Third World Network

1 Please see Article 2(a) of the WHO Constitution.

The current recommended treatment for newly diagnosed patients in the US is Atripla, a fixed dose combination (FDC) made up of three branded drugs; tenofovir disoproxil fumarate ,emtricitabine and efavirenz. Last year a generic form of the antiretroviral drug lamivudine became available on the US market (which shares the same molecular structure as FTC and can thus be substituted in a combination treatment regimen) and a generic version of Efavirenz is expected in the relatively near future.

The entry of these generic equivalents mean that instead of issuing Atripla as an FDC, doctors could put patients on a 3-pill a day regimen including the two generic versions and branded tenofovir disoproxil fumarate, an option that could save $1 billion for the US who last year spent $9 billion procuring antiretroviral drugs.  Generic drugs are much cheaper than their monopolised branded equivalents, as widespread competition amongst generic manufacturers  pushes prices down.

The quoted study used modelling to compare the branded Atripla regimen with a combination of generic efavirenz and lamivudine with brand tenofovir disoproxil fumarate. However, the study did not compare like with like and has been misinterpreted.

The reporting of the study confuses adherence to treatment with drug efficacy. From a clinical perspective FDCs have advantages over separate pills. Logically it is easier to take one pill a day, than three pills a day, thus people adhere better to their treatment regimens when their ‘pill burden’ is lighter. Adherence is important as missing pills, or taking them at the wrong time can lead to drug resistance and ultimately treatment failure. However, missing a pill does not mean that the actual drug is not efficacious but rather that the patient finds it harder to take three pills than to take one.

What the study and the reporting of it fail to mention is that quality assured generic FDCs of Atripla are currently available on the global market- generic Atripla is manufactured by several generic companies  and the lowest cost for a quality assured¹ FDC available in developing countries is currently only US$ 197 per patient per year²- less than 1% of the price paid for the branded product in the US. The issue is just that these medicines are not available in the US due to decisions of the US government. Generic companies have led the way in producing FDCs for developing countries, whilst people in wealthy countries had to continue to take multiple pills due to restrictive patent systems.

The issue in question is not around whether generic drugs are less effective, which is an incorrect assumption based on a misreading of the study. It is rather whether restrictive and anti-competitive patenting activity carried out by the pharmaceutical industry to protect their profit should be allowed to block effective and less expensive FDCs from being available to people living with HIV. Without constant patent ever-greening (modifying existing drugs in order to lengthen patent terms) an effective generic version of Atripla would be available in the US, like it is in developing countries. The real question is whether people should suffer in order to allow greater profits for the pharmaceutical industry.

¹ Products quality assured by US FDA and WHO prequalification.

² For a list of generic FDCs of TDF/FTC/EFV please see, Médecins Sans Frontières, ‘Untangling the Web of Antiretroviral Price Reductions’, (October, 2012), http://utw.msfaccess.org/drugs/4fe29ea5850dfc2ba800001f

For photos of the demonstration, please check our Flikr page: http://www.flickr.com/photos/90958241@N04/

A demonstration will take place on Monday 10th December (Human Rights Day) against the Anti-Homosexual Bill being introduced in the Ugandan Parliament. If made law, this Bill will lead to the persecution of lesbian, gay, bisexual and transsexual (LGBT) people in Uganda; to the imprisonment of anyone known to be in a same sex relationship; and originally called for the death penalty in certain circumstances.

Demo Information Flyer

The Stop AIDS Campaign will join a coalition of human rights groups, LGBTI organisations and sexual health  in urging the Ugandan Parliament to drop this discriminatory Bill and respect the universal human rights that are embodied in their nation’s constitution.

Our Demands

If you’re interested in joining us, the demonstration (on.fb.me/VInUwy) will take place outside Uganda House (nr. Trafalgar Square) on Monday 10th December (Human Rights Day) from midday until 13:30.

Letter to President Yoweri Museveni

Letter to Prime Minister David Cameron

We look forward to seeing you there. If you’re unable to attend, but would still like to get involved with the campaign, please:

1) Sign one of the following e-actions:

www.avaaz.org/en/uganda_stop_gay_death_law/
www.allout.org/en/actions/uganda-now

2) Directly support LGBT organisations in Uganda:

www.sexualminoritiesuganda.net

3) Write to Ugandan Parliamentarians:

www.amnesty.org/en/appeals-for-action/uganda-anti-homosexuality-bill