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Some notes from stakeholders meeting on TTIP and Intellectual Property Rights

This meeting was mainly led by Pedro Velasco who is in charge of IPR for the Directorate General of Trade of the European Commission and who was one of the main ACTA negotiators

There were around 20 “stakeholders” present, the majority representing industry, as well as wine growers and farmers. TACD was represented by James Love of KEI and myself. Also present were a few digital rights organizations.

The meeting was not very informative since Mr. Velasco was quite tight lipped and because the negotiations have not yet begun. Many of his answers to questions were very ambiguous and non-commital.

According to Pedro Velasco, head negotiator on IPR of TTIP, “the aim is not harmonization, because that is impossible, but a much more narrow scope. IPR will be a small chapter only on issues of common interest.”

The controvesial issue of Geographical Indications of mainly food products can be solved in a pragmatic way. Concessions by the US on this issue can be compensated by more opening up of the EU market to US agricultural products.

Another practical issue is to facilitate and improve EU company access to trademark and patent offices in the US to favour reductions of costs for greater protection.

Both the US and the EU want to prevent the theft of trade secrets by China.
The cooperation in fighting IPR infringement globally through better enforcement will also be on the agenda. Another problem is that copyright related rights are protected differently in the EU and the US.
Velasco also implied that the French defense of the cultural exception in TTIP is “something that doesn´t affect IPR”.

GIs of agricultural products will be one of the most difficult discussions along with US wanting lowering of tariffs of agricultural products.  He hints at a trade off of the US accepting some GI restrictions in exchange for greater access to the UE agricutural and food market.

Harmonizing the highest level of IPR from both sides is not a realistic goal.
Investment protection and dispute mechanisms do affect IPR directly according to the EC.
Velasco sees as a possibility of much greater protection (secrecy) for clinical trial data on medicines in TTIP.

He denied that TTIP was going to be a “global benchmark” for 3rd parties.
Neither highest IPR enforcement nor highest copyright exceptions will be harmonized in this agreement.

As far as transparency goes the EC has made no commitment to provide any public access to the negotiating postitions and texts. To the contrary, if there are no leaks only big industry (via the US) will have real time access to the relevant documents.

 

Below is a PDF from my presentation at the May 16, 2013 event in the EU Parliament on the Economic Crisis and Access to Medicines in Europe. While the main purpose of my talk was to discuss delinkage, I began with some data on the EU market and R&D outlays. I have pulled out one figure and two tables from the presentation and offer some comments here.

The figure below simulates the shape of the demand curve for Europe, if one assumes a constant elasticity of income for products, and insurance in each market.

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Professor Brook Baker has written a 5800 word commentary on the negotiations for a treaty on copyright exceptions for persons who blind or have other disabilities. A copy of the paper is available here. The title of the paper is:

Challenges Facing a Proposed WIPO Treaty for Persons Who are Blind or Print Disabled
Professor Brook K. Baker
Law and Society Association Annual Meeting, June 2, 2013

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Dear friends:

Today the new head of pharmaceutical company Lilly UK Jean-Michel Cosséry said that patients don’t want companies like his to spend their money sharing “old data.” These “old data” are, of course, the results on which all treatments in current use are based! Perhaps he is hoping that AllTrials can be headed off into a siding, like all previous attempts to establish transparency.

A committee of MEPs will soon vote on proposals that would increase transparency of clinical trials. However, there are 350 lobbyists for the pharmaceutical industry at the European Parliament. MEPs are hearing Cosséry’s arguments against transparency (and others) every day. We have until 29th May to make sure they hear our arguments.

The trust of patients who have volunteered for clinical trials is betrayed when findings generated by their participation are locked away
Incomplete information means doctors could make bad treatment decisions and miss opportunities for good medicine
Researchers don’t know what was found in previous trials, or even that some trials happened, so trials are repeated unnecessarily
If you are in Europe:

The committee looking at the clinical trial regulation has 67 MEPs from 22 different European countries. Their names, the countries they represent and their email addresses can be found here. http://www.europarl.europa.eu/committees/en/envi/members.html#menuzone

Please write to the MEP(s) from your country telling them why you want increased transparency. Let us know if you have written to them and if you get a response.

If you are not in Europe:

We know these kinds of discussions are going on with every regulator around the world. Please talk to us about how AllTrials can take off in every country.

Best regards

Síle

www.AllTrials.net

Please donate at https://www.justgiving.com/alltrials

Markus Beyrer thinks blind people should not have robust copyright exceptions, because it might set a precedent for patents on health or climate technologies

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Joint Letter to the 66th World Health Assembly: Follow-up of the report of the CEWG

20 May 2013

Distinguished Delegate,

We urge the World Health Organization (WHO) and its Member States to exercise leadership, ambition and innovative thinking in developing new paradigms to take forward the work of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) in reconciling the objectives of stimulating medical innovation and ensuring access for all.

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On Monday, 13 May 2013, the Supreme Court of the United States unanimously held that patent exhaustion does not apply to second, third or nth generations of seeds. In an opinion authored by Justice Kagan, the court found that patent exhaustion does not apply to seeds because later generations constitute new copies of the invention.

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Intervention of MEP Alejandro Cercas at opening of conference:
“Can EU citizens afford their medicines?” 16th of May, 2013

Welcome to the S and D conference “Can EU citizens afford their medicines? The economic crisis and access to medicines in Europe.”  Today we shall consider one of the important social impacts of the current financial and economic crisis: the lack of access to quality health treatment.

When we speak about the economic crisis we usually focus on percentages of debt, the GNP,  bank bailouts and austerity measures.  We  often consider the health of macro-economic indicators but rarely do we consider the physical health of millions of human beings affected by this situation. Europeans want the EU to be just as concerned about the health of  its citizens as the health of large banks. But something must be very wrong with our political priorities if the European institutions can devote billions of euros to rescue the high finances of a member state but they cannot rescue many of  its citizens who today cannot afford a life-saving cancer drug.

It is simply unacceptable that millions of European citizens today cannot afford the best life-saving drugs. It is  also against the basic principles of the EU that millions of immigrants and other vulnerable populations across the EU have been excluded from essential public health care due to austerity measures .

The context is clear. The EU can only demand more discipline if there is more justice. More fiscal responsibility must be accompanied by more social solidarity. More EU economic integration must mean more integration  of social norms at the same time,  which means a broad convergence in access to health care across Europe. Unfortunately, that is not happening, at least over the last five years.

Without more justice and social cohesion there cannot be more Europe, or,  at least a Europe with broad public support.  Recent Eurostat opinion polls reflect a growing and worrisome crisis of citizen confidence in the European project.  Even if the drastic austerity measures being carried out in many EU countries, including my own, Spain,  someday regain the confidence of financial markets, we risk losing the confidence of a large proportion of Europeans.   If we choose to ignore the political and human costs of weakening our education, health and social welfare systems,  we may well be dealing a terrible blow to the future of the European Union.

Getting back to the question posed in the title of this conference: “Can EU citizens afford their medicines?”  It seems to be clear that in EU member states most affected by the crisis that the answer is probably no. This is for two simple reasons: on one hand the financial and economic crisis has meant that EU member states and individuals have much less money available to pay for these treatments and on the other hand many medicines are extremely expensive, especially those under patent monopolies, often more expensive in the EU than outside the EU.

The public health-care systems of around half of EU member states are having a very hard time paying the price of advanced, life-saving medicines. In many cases European patients must try to pay for these medicines partially or totally out of their own pockets. As austerity measures increase,  patient co-payment for important medicines also increase at the same time. As a result many people must choose between paying for their medicines and paying for their basic sustenance such as housing or food.

Very serious questions  also need to be posed concerning our biomedical innovation model, our public medicine procurement, our pricing systems and our taxpayer financed research.

We all know that the EU does not have direct competences over health care but still there is much that the European institutions can do to protect the right to health-care in the EU. The EU does have direct competences in areas such as the Internal Market, Competition, Intellectual Property Rights and Research that do have a profound effect on the accessibility, affordability and efficacy of the medicines that can save lives.

In the middle of this severe crisis, it is not acceptable that billions of public investment in research end up financing the  privatization of essential medical knowledge and produces medicines with astronomical prices that are unaffordable to most public health systems in the EU. It is not acceptable that the same taxpayers who finance an important part of medical research can not afford the products that are produced with their money.   Instead we should be promoting the creation of health related public knowledge goods  with all research financed with public money that can produce the essential medicines we need at affordable prices  We also need socially responsible licensing for affordable medicines to assure that Public-Private partnerships contains social conditionality.

It is not legal in the EU nor morally acceptable for drug companies to pay generic companies, pharmacists or doctors to keep affordable generic medicines off the market.

The European Commission should coordinate a voluntary system of joint public procurement of medicines so every hospital or region of Europe should not be left on its own to negotiate its procurement of medicines; we need to pool together the bargaining power of public authorities to guarantee affordable health treatments.

Greater transparency and sharing of knowledge across the EU  in the evaluation of  our medicines is also very important because we  need to know if the medicines we buy really work and what their secondary effects are.

In conclusion, a healthy European economy cannot be built with measures that deny quality health treatments for Europeans. We can only build the future of Europe by re-gaining the confidence of Europeans and one way of doing that is showing that the EU can take effective measures in favour of access to medicines. Thank you and I wish you a very successful conference.

 

Rough context notes for May 16th talk at conference about access to medicine in Europe

bit.ly/17uCalc

1. Affordability: High price of medicines for states and for individuals. Can we afford allowing millions of people to be sick and for many of them to die. Is it ethical that millions of persons, citizens or not, are denied treatments when the marginal costs of the medicines is minimal?

2. Health Conditionality of rescue operations: Why can´t part of rescue operations of banks or sovereign debt be set aside for keeping people alive or healthy in public health systems?

3. Transparency: Know what prices paid in procurement of hospitals, states and regions. Efficacy and safety of new and existing medicines is not known because clinical trial data is not available. How can we spend our money right if we don´t even have doctors and patients access to the essential data about how and if the drugs work? Clinical trials regulation.

4. Public risk, public return: We need social conditionality of affordability of public investments in biomedical research. 70% Cancer research public money but many drugs cost up to 100 thousand euros a month. Taxpayers are risk capitalists but if medicine is successful does not only not revert into the public good, but we have to face unaffordable prices under patent monopoly. “Affordability and accessibility” but Council against in Horizon 2020.

5. Together we stand, divided we fall: pooled procurement, Why don´t countries get together to buy medicines together? If the EC it is against the rule, we should change the rules.

6. Justice. Inclusion: Inmigrants and other vulnerable groups. Cheap labour but no health care. Where are EU basic values.

7. Public knowledge goods: Billlions in H2020 and other publicly financed biomed research results should become publicly available and shared for development of creation generic products from the first day to save lives and public health systems.

8. Tricks, bribes and pay to delay. Me Toos (over 90% little new therapeutic value), evergreening (never off patent), pay to delay to prevent generics(documented by EC), paying doctors directly to prescribe brand name drugs…

9. “Industry Myths” – We need high prices to pay for R and D. Max 16% of profits spent on R and D according to Pharma. Much more spent on on marketing. Over 12% of medicines researched by industry at any level end up authorized.

10. “De-linkage” Disassociate R and D costs from the production and  final price of medicines. New Models: Innovation inducement prizes, PDPs, Patent pooling, prizes, equitable licensing, open source, open data,

Business as usual is not an option: Health first : Like in South Africa with HIV/Aids: Health emergency: Compulsory Licenses is also an option if other strategies fail. Health is more important than patent monopolies.

 

  Expert and policy-making conference

How can we provide access to affordable medicines in Greece?

The situation on the ground and possible solutions

European Parliament office (Amalias Avenue 8) in Athens, 31 May 2013

CONCEPT

Crisis and access to medicine in Greece: situation and responses

The current financial crisis and the conditions imposed on the Greek state has had a profound impact on the ability of the Greek public health systems to adequately provide many necessary biomedical products for its citizens.

This half-day conference in Athens organized by TACD with the support of MEP Nikos Chrysogelos (Greens/EFA, EL), Médecins Sans Frontières (MSF Greece) and Médecins du Monde (MdM Greece) aims at presenting information on the situation of Access to Medicines (henceforth A2M) in Greece today and to consider some possible responses to this problem. Issues to be dealt with would be the situation on the ground with regards to accessibility and affordability of life saving medicines. Also to be reported would be the degree of state payments or out of the pocket citizen expenditure under the strain of the public debt crisis.

Experts will present possible alternatives to the high price of medicines and will also consider new models of biomedical innovation that is at once affordable and health needs-driven. These proposals will also include new forms of pooled medical procurement, new licensing systems of medicines in order to promote generic access to key medicines and changes in EU policy to facilitate access to medicine in Greece.

Objectives

To focus European and Greek attention on the state of access to medicine inside Greece today and the health impact of the present financial crisis.

To influence and initiate major policy debates in the in Greece and the EU institutions on legal, financial and scientific measures that could be employed to guarantee the right to healthcare.

The Athens conference will be a follow-up to the EU wide conference entitled “Can EU Citizens Afford Their Medicines?” which took place at the European Parliament in Brussels on 16 May 2013.

Instruments

A manifesto by experts on the topic.  The preparation of a “Athens Declaration on Access to Medicine in Greece”. 

Speakers and experts

Public health experts, academics, generic industry, NGOs, economists and policy makers

 AGENDA

How can we provide access to affordable medicines in Greece?

The situation on the ground and possible solutions

09.00-09.15: Registration and coffee

09.15-09.30: Welcome and introductory remarks

Nikos Chrysogelos, MEP, Greens/EFA Group in the European Parliament

David Hammerstein, Senior advocate,  TransAtlantic Consumer Dialogue, Brussels

09.30-10.30: First panel discussion

The situation on the ground in Greece concerning access to life-saving medicines

Nicky Voudouri, Medical Department Coordinator, PRAKSIS NGO

Giorgos Krassaras, Special Advisor, Médecins du Monde (MdM Greece)

Despina Makridaki, President, Association of Pharmacists within state hospitals (PEFNI)

Maria Skouroliakou, Vice-President, National Organisation for Medicines (EOF) (tbc)

Ioannis Dagres, Treasurer, Athens Pharmacists’ Association

Moderator: David Hammerstein, Senior Advocate, TransAtlantic Consumer Dialogue, Brussels

10.30-11.00: Q & A

11.00-11.15: Coffee break

11:15-12.30: Second panel discussion

Looking forward: action-oriented solutions to access to medicine crisis in Greece in the short, middle and long term

Els Torreele, Director, Access to Medicines initiative, Open Society Foundation

Médecins Sans Frontières (MSF Greece)

James Love, Director, Knowledge Ecology International

Lycurgus Liaropoulos, Professor, Health Economics and Health Care Management, University of Athens

Nikos Kefalas, Vice-President, Hellenic Association of Pharmaceutical Companies (SFEE), Managing-Director, Janssen-Cilag Pharmaceuticals

Fei Kosmopoulou, Managing-Director, Panhellenic Association of Pharmaceutical Industries (PEF)

Representative of the Greek Ministry of Health

Representative of the Task Force for Greece (tbc)

Moderator: Tasos Telloglou, Reporter, Kathimerini newspaper & Neoi Fakeloi (SKAI TV)

12.30-13.15: Q & A

13.15-13.30: Closing remarks

13.30-14.00: Lunch

 RSVP: Please confirm your attendance before May 27 by writing to a2m.athensconference@gmail.com

The conference will be webstreamed and translation will be provided.

 

 

 

 

 

 

Cita de David Hammerstein del Diálogo Transatlántico de Consumidores

“La Unión Europea parece estar más preocupada por la salud de los bancos que por la salud de la ciudadanía europea. Las radicales medidas de austeridad impuestas en distintos países de la UE ha significado que millones de personas no tienen acceso a tratamientos esenciales en los centros de sanidad pública.
Debido a unas políticas totalmente pro-industria de la UE existen unos precios inasequibles para muchos medicamentos y tenemos una crisis creciente de acceso a medicamentos dentro de la Unión Europea. En cambio, una política orientada hacia las necesidades de salud de la mayoría incluiría una estrecha coordinación entre países europeos en las compras públicas de medicamentos, unas reglas más flexibles de propiedad intelectual y medidas anti-monopolio para fomentar la competencia de productos genéricos y su importación, normas para la condicionalidad social para el uso de los resultados científicos financiados con fondos públicos y  una regulación estricta de la transparencia para poder evaluar la eficacia y seguridad reales de los productos farmacéuticos.  El modelo farmacéutico actual está dominado por unos gastos masivos en marketing, unos pobres resultados en innovación y unos precios muy altos mantenidos artificialmente. La crisis ha convertido la situación en insostenible.”

http://www.a2meurope.eu/index.php?id=home

Press statement quote for Conference “Can EU citizens afford their medicnes?” on May 16th, 2013 in European Parliament, Brussels

David Hammerstein TransAtlantic Consumer Dialogue:

“Today the EU seems to be much more concerned about the health of large banks than the health of its citizens. Radical austerity measures imposed on a number of EU member states means that millions of persons are being denied life-saving medical treatment by public health systems.  Because the EU´s one-sided pro big-pharma purely market oriented policies allow unaffordable high prices for many treatments, now we have a growing access to medicine problem inside Europe. A health needs oriented EU policy would include pooled procurement of key medicines, flexible IPR rules and anti-monopoly measures to promote generic competition and imports, social conditionality norms on the results of publicly financed biomedical research and stringent transparency regulations so we could evaluate the real efficacy and safety of existing medicines. We also need a “de-linkage” of R and D costs from the price of life-saving medicines. The present  EU pharmaceutical model is dominated by massive marketing costs, poor innovation outcomes and artificially maintained high prices. The crisis has made this situation unsustainable.”

On May 10, 2013, a very revealing freedom of information request was made available from the UK Intellectual Property Office (IPO). The request had been filed on April 14, 2013 by the journalist Glyn Moody, for:

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A PDF version of our comments is available here.

People have until midnight May 10, 2013 to file comments, here:
http://www.regulations.gov/#!documentDetail;D=USTR-2013-0019-0001

This is the table of contents.

Comments on the Administration’s Intention to Enter Into Negotiations for the Transatlantic Trade and Investment Partnership (TTIP) Agreement
Response to Docket No. USTR-2013-0019

Introduction
Transparency

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Note, we are adding some video clips from the meeting here:

May 13, 2013. KEI meeting on WIPO negotiations. http://www.youtube.com/playlist?list=PLLw9jWaZPEpzafm6_61VtLb6aW-nFaINa

On May 13, 2013, KEI will host a 12:30 to 2:30 brown bag lunch for a discussion of the WIPO Treaty for the Blind negotiations. It will be possible to attend in person, or follow the meeting on the telephone.

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On April 15, 2013, the Intellectual Property Owners Association (IPO) sent a letter to Teresa Stanek Rea, the Acting Under Secretary of Commerce for Intellectual Property and the Director of the U.S. Patent and Trademark Office, setting out the IPO "concerns" about the proposed WIPO treaty for persons who are blind or visually impaired. (Copy here).

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On April 26, 2013 I attended a half day meeting on "A Human Rights Approach to Intellectual Property and Access to Medicines" organized by the Yale Law School and the Yale School of Public Health. These are notes from my interventions on behalf of KEI.

1. KEI does a lot of work on intellectual property rights that has impact on human rights. We do not always give prominence to human rights law or the language of human rights, although at times and in the right context, it can be important to do so.

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Below is the PhRMA press release on the Special 301 Report.

Key points in the PhRMA release:

* PhRMA "dismayed that USTR did not grant an out-of-cycle review for India." PhRMA claims that India decisions involving German owned Bayer and Swiss owned Novartis "disproportionately impacted U.S. biopharmaceutical companies." (Perhaps PhRMA could have said, companies that have ownership claims on the US government).

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Today USTR held a one hour "listening session" with several Washington, DC public interest groups. The topic was the Transatlantic Trade and Investment Partnership (TTIP) with the European Union.

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On 1 May 2013, USTR released its 2013 Special 301 Report. Ukraine was put on the Priority Foreign Country list this year, a designation not used by USTR for several years. USTR's 2013 report spends more than six pages discussing China and two full pages on India. Below are some comments regarding this year's report.

Least Developed Countries

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