“Can we afford our medicines?” November 12th event.

‘’Can we afford our medicines?
The access to medicines crunch in Europe”

European Parliament (room A3G-3), 12 November 2014, 12:30-15:00

We would like to invite you to the conference “Can we afford our medicines? The access to medicines crunch in Europe” under the auspices of MEPsNessa CHILDERS (S&D, IE), Beatriz BECERRA BASTERRECHEA (ALDE, ES), Kostas CHRYSOGONOS (GUE/NGL, EL), Michèle RIVASI (Greens/EFA, FR) with the support of the TransAtlantic Consumer Dialogue (TACD), Salud por Derecho, Health Action International (HAI) Europe, Doctors of the World – Médecins du monde International Network, Universities Allied for Essential Medicines (UAEM).

Health is a fundamental universal right and access to medicines is part of it. The EU and its Member states are committed to universal and equitable access to healthcare. Nevertheless, millions of European patients suffer from the lack of affordability of many life-saving medicines across Europe. The debate will examine the status quo regarding access to medicines in Europe and explore policy recommendations for more affordable medicines. Possible solutions to be considered will be: new forms of pooled procurement, price and data transparency, cost-therapeutic benefit assessment of medical products and greater generic competition. We shall also debate new biomedical R&D strategies that increase the social return of public investments and promote affordable health-driven innovation which “de-links” research costs from final medicine prices.

Programme (12:30-15:00, room A3G-3)

 

Welcoming remarks by sponsoring MEPs

 

Affordable access to medicines: the situation on the ground

Moderated by Jamie Love @jamie_love, Director, Knowledge Ecology International (KEI) & U.S. Chair of the Intellectual Property Committee, TACD 

 

  • Chloé Forette @Chloe_MdM, Harm Reduction Advocacy Officer, Médecins du Monde @MdM_France
  • Gonzalo Fanjul @GonzaloFanjul, Policy Director, IS Global Barcelona Institute for Global Health @ISGlobalorg
  • Rohit Malpani @MSF_access, Director, Access Campaign, Médecins Sans Frontières (MSF)

 

Q&A session

 

What can we do about the high cost of medicines?

Moderated by Ellen ‘t Hoen @ellenthoen, Medicines Law & Policy.

 

  • Teresa Alves, International Policy Adviser, La Revue Prescrire,
  • Prof. dr. Graham Dukes, University of Oslo
  • Prof. dr. Huub Schellekens, University of Utrecht

 

Q&A session

Concluding remarks by sponsoring MEPs

The European Commission will be represented by DG Enterprise & DG SANCO.

Please join the discussion on twitter using #a2mEurope. Also note that the event will be webstreamed live (more information to follow).

We would kindly ask you to register your attendance (please mention title & organisation represented) to a2m.europe@gmail.com by Thursday 6 November 2014. Should you require a badge to access the European Parliament, please do not forget to provide us with your full name, nationality, passport/ID number and date of birth.

 

A light lunch will be served at the start of the event.

European Parliament event: “Can we afford our medicines?” November 12th

‘’Can we afford our medicines?
The access to medicines crunch in Europe”

European Parliament (room A3G-3), 12 November 2014, 12:30-15:00

We would like to invite you to the conference “Can we afford our medicines? The access to medicines crunch in Europe” under the auspices of MEPsNessa CHILDERS (S&D, IE), Beatriz BECERRA BASTERRECHEA (ALDE, ES), Kostas CHRYSOGONOS (GUE/NGL, EL), Michèle RIVASI (Greens/EFA, FR) with the support of the TransAtlantic Consumer Dialogue (TACD), Salud por Derecho, Health Action International (HAI) Europe, Doctors of the World – Médecins du monde International Network, Universities Allied for Essential Medicines (UAEM).

Health is a fundamental universal right and access to medicines is part of it. The EU and its Member states are committed to universal and equitable access to healthcare. Nevertheless, millions of European patients suffer from the lack of affordability of many life-saving medicines across Europe. The debate will examine the status quo regarding access to medicines in Europe and explore policy recommendations for more affordable medicines. Possible solutions to be considered will be: new forms of pooled procurement, price and data transparency, cost-therapeutic benefit assessment of medical products and greater generic competition. We shall also debate new biomedical R&D strategies that increase the social return of public investments and promote affordable health-driven innovation which “de-links” research costs from final medicine prices.

Programme (12:30-15:00, room A3G-3)

 

Welcoming remarks by sponsoring MEPs

 

Affordable access to medicines: the situation on the ground

Moderated by Jamie Love @jamie_love, Director, Knowledge Ecology International (KEI) & U.S. Chair of the Intellectual Property Committee, TACD 

 

  • Chloé Forette @Chloe_MdM, Harm Reduction Advocacy Officer, Médecins du Monde @MdM_France
  • Gonzalo Fanjul @GonzaloFanjul, Policy Director, IS Global Barcelona Institute for Global Health @ISGlobalorg
  • Rohit Malpani @MSF_access, Director, Access Campaign, Médecins Sans Frontières (MSF)

 

Q&A session

 

What can we do about the high cost of medicines?

Moderated by Ellen ‘t Hoen @ellenthoen, Medicines Law & Policy.

 

  • Teresa Alves, International Policy Adviser, La Revue Prescrire,
  • Prof. dr. Graham Dukes, University of Oslo
  • Prof. dr. Huub Schellekens, University of Utrecht

 

Q&A session

Concluding remarks by sponsoring MEPs

The European Commission will be represented by DG Enterprise & DG SANCO.

Please join the discussion on twitter using #a2mEurope. Also note that the event will be webstreamed live (more information to follow).

We would kindly ask you to register your attendance (please mention title & organisation represented) to a2m.europe@gmail.com by Thursday 6 November 2014. Should you require a badge to access the European Parliament, please do not forget to provide us with your full name, nationality, passport/ID number and date of birth.

 

A light lunch will be served at the start of the event.

Notes on new EC Commissioners about access to knowledge

Notes on access to knowledge and IPR challenges of the new European Commission

 

 

Carlos Moedas, Commissioner for Research, Science and Innovation

 

It is generally accepted that copyright constitutes a barrier for EU researchers and weakens their ability to access published research results. The new commissioner, though it is not his direct competence, will probably support a EU copyright reform that includes some kind of EU-wide copyright exception for scientific researchers.

 

The new Research Commissioner will also have to deal with the application, very partial to date, of the EU´s new mandatory policy of open access to EC funded scientific published research results and the promotion of open data policies to become the norm by 2020. This also includes an alignment of EU member states open access policies through the European Research Area.

 

It will also be interesting to see how Moedas uses the mechanism of innovation inducement prizes in the area of biomedical research of Horizon 2020 after a few pilot projects have been launched.

 

The transparency, IPR rules and social return of the public-private partnership Innovative Medicines Inititative, particulary concerning antibiotic resistance, is also important to follow. The EU´s positions on the WHO process on new models of R and D for medicines will also be important to monitor.

 

Gunther Oettinger, Commissioner for Digital Economy and Society

 

Oettinger has committed himself to presenting an EU copyright reform proposal within a year. It is important to note that the competence over EU copyright has moved from the DG Internal Market to DG Connect that will be headed by Oettinger. The copyright unit headed by Maria Martín Prat will now move under a more copyright reform regime. The big challenge will be to try to overcome very different national copyright and licensing rules to conform a single digital market. Harmonizing exceptions and limitation to copyright, including exceptions for Text and Data mining as well as for libraries, might be some of the issues.

 

The regulation of cloud computing, big data and data protection will also be big challenges that will partially be considered with the context of the TTIP negotiations and trans-Atlantic business parctices.

 

It will be interesting to follow if the new Commissioner mandates any changes in EU strategy at WIPO on both the proposed broadcasting treaty and exceptions to copyright for libraries. To date the EU has been radically opposed to copyright reform for libraries at WIPO, to the point of blocking any progress at the UN institution. Another important issue will be the pending EU ratification of the Marrakesh Treaty for visually impaired persons that is blocked due to procedural issues over EU/member state competences.

 

 

Vytenis Andriukaitis, Commissioner for Health and Food Safety

 

While competence over pharmaceuticals, including the European Medicines Agency, has been moved to the Industry DG, the new Health Commissioner has insisted that he would make joint proposals with the Industry Commissioner and that his opinions would carry equal weight.

He has suggested coordinating among EU member states to lower the high price of life-saving medicines, possibly through pooled procurement. No mention of IPR was made during his hearing.

He was adamant about supporting transparency and preventing conflict of interests.

 

 

 

Access to life saving medicines debate in plenary of European Parliament

European Parliament Strasbourg Plenary Session

Subject: Commission statement – Access to life-saving medicines in Europe

Date: September 16 2014

 

Connie Hedegaard, European Commissioner for Climate Action said that the Commission shared the concerns regarding the affordability of new medical products and the related risk of inequalities. She added that the Commission Communication in April 2014 on resilient health systems focuses on increasing accessibility to health services. At the June health ministers’ Council, France raised the issue of the new Hepatitis C treatment. Member states will discuss pricing and reimbursement in the coming months. This new treatment is not an isolated case. Therefore, the Commission is looking forward to the debate on the therapeutic innovation at next week’s health ministers’ Council. As regards, support to medical innovation, the Commission believes in the contribution of the Innovative Medicines Initiative (IMI). She commented that the European pharmaceutical legislation includes a wide spectrum of measures to guarantee access to necessary medicines. The Commission has however no competence to regulate the level of prices. Thus there can be no price caps but it can nonetheless help with the exchange of information between member states. She concluded by saying that another way in which the European Commission could assist member states is through the use of the joint procurement mechanism.

Miroslav Mikolasik (EPP, SK) stated that this is an important topic for patients and saving lives. He emphasized the fact that the situation is not the same across all member states. He added that the high prices of medicines reflect the research that led to their development. Nevertheless, ppharmaceutical companies should not misuse nor abuse their unique position. In the period 2000-2009, public spending for medicines has increased by 76% and this is unprecedented. The EU population is ageing and the prices of new medicines are constantly increasing.

Biljana Borzan (S&D, HR) said that medical progress leads to efficient but expensive medicines. Millions of euros are used to save banks in Europe today while Europeans lack access to necessary medicines. Public funds should be used to promote medical research and development. She called for shorter patents because prices go down when patents expire.

Beatrix Von Storch (ECR, DE) stated that on the 18th of October 2011 the European Court of Justice made that human life begins at the stage when the semen touches the egg. She therefore criticized stem cell research. The European Commission should discourage stem cell research because this equals destruction of human life.

Beatriz Becerra Basterrechea (ALDE, ES) said that Hepatitis C is an infectious disease that constitutes a public health crisis. She favoured the issuing of a compulsory license that will enable the manufacturing of a generic. The EU should challenge the patent legally. She added that the option of joint public procurement should be examined. Egypt imports the generic equivalent of the new Hepatitis C treatment at a price 100 times lower. Another 90 developing countries will benefit from India’s decision to produce generic equivalents. In her view, the Commission should defend the general interest of European citizens. She gave the example of price caps for roaming and wondered what is more important public health or a matter like roaming costs.

Kostas Chrysogonos (GUE/NGL, EL) said that pharmaceutical companies push for ever higher prices through their monopolies. High prices are not the only obstacle to people’s access to life-saving medicines. In reality, the competent bodies inside the EU are not only indifferent towards these prices but also impose spending cuts on health services. The worst situation is faced by those countries under memoranda where the Troika demands continuously cuts in public health expenditure.

Michele Rivasi (Greens/EFA, FR) stated that the new treatment against Hepatitis C affects millions of Europeans. It therefore becomes a real public health question. She called for compulsory licenses against long patents and monopolies. She explained that compulsory licenses will open the markets. There is also the question of medical research. In this respect, the current Western African Ebola crisis is due to the fact that no pharmaceutical company has invested in developing a vaccine because it would not be profitable. In other words, public health becomes a market-driven policy.

Dario Tamburrano (EFD, IT) welcomed the debate. He criticized the fact that DG Industry will be responsible for health matters in the new Commission.

Eva Kaili (S&D, EL) argued that human rights are more important than intellectual property rights. She called for more transparency in order to know what is happening with medical innovation inside big pharmaceutical companies. She called for shorter patents. In her view, the EU should act against these ridiculous prices of medicines. Moreover, she favoured the use of generics.

Branislav Skripek (ECR, SK) said that medicines should be available to all and not only to the privileged ones. He defended people’s access to health care services.

Marian Harkin (ALDE, IE) said that countries undergoing austerity programs are faced with the most serious challenges. The Commission admits that these cuts in health expenditure affect the most vulnerable parts of the society. She called on European Commission president Junker to revisit his decision about assigning health issues such as pharmaceutical products to DG Enterprise and Industry.

Marisa Matias (GUE/NGL, PT) said that these prices are scandalous especially for countries forced to cut their public health budget. She argued that this is shameful profiteering on behalf of big pharmaceutical companies and has nothing to do with funding innovative research. The European Commission might not be able to do much about prices but it can certainly put an end to patent monopolies, if there is political will.

Margrete Auken (Greens/EFA, DK) said that the greed of the pharmaceutical industry is unlimited. Even though, it is a fact that most of medical innovation comes from publicly funded research, industry is allowed to profit from European taxpayers’ money. She added that moving the pharmaceutical industry dossier to DG Enterprise is a cynical idea. Human lives should not be sacrificed for more money.

Giorgos Grammatikakis (S&D, EL) stated that over the past few years, there has been a serious access to medicines crisis in Greece. He explained that many pharmaceutical companies blackmailed the country with shortages and stock-outs. He stressed that small countries like Greece cannot stand up against the big pharmaceutical interests and thus called for increased European cooperation on this matter.

Angela Vallina (GUE/NGL, ES) called for better checks of pharmaceutical companies in the EU. She called for lower prices of medicines. The EU should not be a silent witness when people are dying despite the fact that there is a treatment.

Soledad Cabezon Ruiz (S&D, ES) said that the EU should investigate the profits of pharmaceutical companies. Everyone in Europe should have access to life-saving treatments. She also called for a review of intellectual property rights when it comes to medical innovation and research.

Catch the eye procedure

Joao Ferreira (GUE/NGL, PT) criticized the Commission for not doing more than just talking. He said that the European Commission is part of the Troika which imposes the strictest public health spending cuts.

Connie Hedegaard, European Commissioner for Climate Action reminded that the European Commission has no competence over pricing of medicines. She nevertheless stressed that the Commission can do other things such as promote the exchange of information between member states. She added that it is up to member states to take these matters forward and expressed her certainty that the informal health ministers’ council will have this item on its agenda at their next meeting.

 

 

 

 

Joint civil society letter to Juncker over placing pharmaceuticals under industry

Dear Mr. President-elect,
We are writing to express our astonishment and concern regarding your decision to move the competence for medicinal products and health technologies from the Commissioner in charge of Health to the Commissioner in charge of internal market and industry within the new Commission.
The economic crisis, the ageing of the population, technological advances, and new health threats, including environmental pollution, are all challenging the sustainability of European health systems, and health inequalities between and within European Union (EU) Member States are increasing.
The European Commission, as the guardian of the Treaty, plays an important role in “ensur[ing] a high level of human health protection”. This necessitates an unwavering vision for public health, along with consistent and coherent policymaking to support it.
People living in Europe have the right to high quality, safe, affordable and effective treatments. Pharmaceuticals and medical devices are not – and should not – be considered as any other internal market product because they safeguard people’s health.
The main driver of EU policies concerning pharmaceuticals and health technologies should be promoting and protecting health and patient safety. The Commissioner for Industry and Internal market, however, is mandated to promote the competitiveness of the industry and the European economy. This distinction is an important one to make with delicate issues, such as information to patients and medicine pricing, where the needs of patients can be in conflict with the interests of industry. The shift you are proposing sends the wrong signal to European citizens and patients – namely that economic interests come before their health. This is not the sort of signal the EU wants to send.
In 2009, responsibility for medicines and medical devices were moved into the hands of the health Commissioner to harmonize pharmaceutical governance within Member States and facilitate emergency preparedness. Returning them to the Commissioner for Enterprise and Industry is unjustified and represents a major step back.
Please reconsider this decision – we believe that medicinal products and health technology belong under the responsibility of the Commissioner for health.
We urge you to show bold leadership and to put health interests first.
Yours Sincerely,

Press contact: pierrechirac@aol.com

Question and debate in EP (16-9-2014) on high prices of life-saving medicines

Oral Question posed by French MEP Michelle Rivasi (Greens)

Access to medicines has repeatedly made the headlines in many EU countries over the past 3 months (in France, the UK, Spain, Greece, etc.). The reason for that is the price charged for Sofosbuvir, a drug that can cure hepatitis C. It is sold by the pharmaceutical firm Gilead, which charges generally between 50 000 and 60 000 euros per patient for a 12 weeks course in the Eurozone.

The situation with Sofosbuvir is urgent, but unfortunately it is not an isolated case. This level of prices not only is a new trend but it is becoming a new norm for serious diseases. As a consequence, we, for example, see how it is becoming harder and harder to ensure access to drugs to cancer patients in Europe. It is happening with Kadcyla® a drug for breast cancer, for Nexavar® a drug for kidney and liver cancer. And we are all affected, or soon will be.

The less innovation the pharmaceutical industry brings to the market, the more it prices the new drugs. Abuses of monopoly rights and patents is harming innovation and crushing health systems. We are seeing doctors and medical authorities forced to compromise their professional code of ethics and to invent false reasons of cost-effectiveness to justify sentencing people to death.Nothing in the chain of development of these drugs justifies these prices.

Rationing of life saving medicines in Europe is not acceptable. It is high time to reform a system that is increasingly dysfunctional, and to honestly address the issue of the research and development model we need for medical innovation.

Today 10 to 15% maximum of the price of a medicine will go towards research. Is that really the most effective way to proceed? Instead of paying 100 euros to endure that 10-15 euros will go to research, citizens, communities or States could pay directly the same share for research without having to bear the cost of monopoly.

France raised the issue of Sofosbuvir at the Council and before the Commission during the Summer. What are the Council and the Commission planning on doing to break this deadlock which is becoming deadly for an increasing number of EU citizens? When will we seriously discuss options that do not necessarily please a handful of multinationals but would serve the EU public interest, such as funding mechanisms and financial incentives that are not tied to the granting of exclusive rights and monopolies? When will we impose price caps on medicines the same way we were able to do for roaming?

Gobal Broadcast Treaty and public interest

Statement to WIPO SCCR 28 on Broadcasting Treaty by TransAtlantic Consumer Dialogue

 

Broadcaaster lobby material

Broadcaster lobby material

 

Broadcasting Treaty: Collateral damage to public access

 

Consumers and users around the world do not want new layers of complications, barriers and costs added to their access to information, news and knowledge. The strong push towards a binding Broadcasting Treaty with a wide scope is in stark contrast with the rigid opposition on the part of a number of member states to even discussing new global norms to facilitate the essential cultural and scientific role played by libraries and archives. This contradiction is not understood by millions of consumers and citizens around the world.

Do we want to follow the greatest success stories with regards to public broadcasting that are based on flexible, fair copyright frameworks or do would we like to create new complicated and expensive legal barriers that inhibit innovative and plural public broadcasting?

If we consider public broadcasting a public good, is it acceptable to move toward creating a new global binding legal standard of copyright protection for broadcasting signals without first making clear exceptions and limitations to this new norm that are essential to the flow of information and culture?

We would like to know if the Broadcasting Treaty will threaten the right to freely quote broadcasts or circulate snippets of news. Consumers and users must know if the concrete scope of this legal norm will mean new obstacles to what we often access and share daily. We are afraid we might be opening up an endless, incomprehensible pandora box of overlapping rights on content between non-creators (broadcasters) and creators. We are also concerned that the protection of post-fixation rights can have a very negative impact in the online use of culture, news and information by consumers and users.

In the consideration of a new international legal norm for broadcasters we must not forget the common good of the free flow of information for citizens. The focus of our work should not be limited to satisfying the wish-list of one special interest group while ignoring the possible unintentional negative consequences on normal users.

Very clear public interest red-lines need to be drawn up, the scope of rights must be narrowly, clearly defined and the social impact of these new rights must previously be evaluated by independent experts.

David Hammerstein, TACD

TRIPS, the European Commission and the European Medicines Agency´s clinical trial transparency policy

Nothing in international intellectual property law constitutes a serious barrier to the publication of clinical trial data for the sake of public health.

 

In his letter to the European Ombudsman dated 22 May 2014, the Director of the European Medicines Mr Rasi refers to a “clear message” of the European Commission relating to the need to ensure compliance with national and international agreements, including, but not limited to, TRIPS and copyright legislation. It can be deduced that the EMA has received a “clear message” that its “proactive” clinical trial transparency policy could be violating international IPR law.

 

One cannot derive from TRIPs article 39.3, that refers to clinical data, any general obligation against the disclosure of clinical trial data.This is clear in the text itself:

‘Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.’

Moreover, a number of interpretations of TRIPs clarify that the disclosure of clinical trial data for the sake of transparency and public health cannot be considered “unfair commercial actvity” (which is not defined). A number of WHO/WTO documents insist that clinical trial disclosure and article 39.3 of TRIPs should be seen within the context of the Doha Declaration on flexibilities for Public Health. See this WHO document: http://www.who.int/medicines/areas/policy/protection_of_data.pdf and from the WTO http://wto.org/english/res_e/booksp_e/pamtiwhowipowtoweb13_e.pdf;

It is true that to date there is no case law precedence nor other very authoritative interpretations on the TRIPs articles referring to clinical trial data. But in this context it specially surprising that the European Commission (DG Trade and DG Enterprise) is pressuring the EMA to roll-back on its data transparency measures with the pretext of international patent, trademark and copyright concerns that are not backed up by a clear legal basis.

Human rights vs. patent monopolies on medicines in Greece

Human rights VS Patent Monopolies on medicines

Written by Mr. Panayotis Kouroublis, Greek MP, SYRIZA parliamentary representative

Published at http://www.koutipandoras.gr/article/113023/anthropina-dikaiomata-enantion-pneymatikon-dikaiomaton on 3 May 2014

 

“Diseases such as cancer are considered urgent only when the patient is in the final stage” according to the Greek Minister of Health Adonis Georgiadis in the “Wall Street Journal”. This is the response of the Ministry of Health in relation to the uninsured cancer patients who are forced to discontinue their treatment because they cannot afford it. The blatant cynicism displayed by the government is not only due to the dogmatic faith of the Greek government in the agreements with the Troika but also due to the government’s incapacity to effectively address a series of problems. Minister Georgiadis stresses that there is no room for flexibility in the austerity measures. Nevertheless, solutions  are feasible and are foreseen by international law. Most importantly, these have already been implemented by other European countries.

 

The WTO TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement enables a country facing an emergency to issue a compulsory license for products protected by copyright. If Greece decided to use this legal provision, it could obtain anticancer and other drugs at much cheaper prices while bypassing, in an entirely legitimate manner, the patents held by multinationals. Compulsory licensing has been used in numerous countries including Germany, Italy and the USA. This solution should be taken into account by the Greek government which nonetheless refuses to examine it, despite its proven efficacy. Another solution that is worth considering would be the collective supply of medicines (pooled procurement) by several EU member states joining forces. If Greece decided to negotiate with pharmaceutical companies together with other countries of southern Europe; it could obtain much cheaper prices for much-needed medicines.

 

The current government is accountable to the Greek people because of its persistent refusal to take advantage of the considerable flexibility provided by the European and international context as regards the supply and procurement of drugs. This is the least, a responsible leadership should have done in view of the humanitarian crisis, the country is faced with. For SYRIZA; the political force fighting for the peoples of Europe and not the multinationals, the bar stands even higher. As a leading opposition party in a country found at the heart of the European financial  crisis;  SYRIZA’s leader, a candidate for the Presidency of the European Commission will strive to  broaden the scope for a different Europe. SYRIZA must question the overall status quo of pharmaceutical research funding, which results in the exclusion of millions of patients from health care to the benefit of some big pharmaceutical companies.

Funding for research into new drugs based on intellectual property creates legal monopolies that favour the companies that have developed these drugs. In essence , the company that owns the patent of a drug is the only one entitled to sell it and it can do so at any price it wishes. Big pharmaceuticals argue that this is the only way to meet the high costs of research and development. The truth is that the cost of R&D constitutes a very small percentage of the  total cost of developing a new medicine. In other words, expensive price tags are a way for profiteering for big companies while putting human lives at risk. It is indicative that prices of anticancer drugs have doubled over the last decade; despite angry reactions by doctors and patients’ associations .

 

The current patent system results in prohibitive costs for patients as well as in a huge waste for healthcare providers. It most importantly raises a wall between the drugs and those who need them the most. It has additional side effects: such as the development of drugs with questionable efficacy, the encouragement of agreessive and misleading  promotional practices on behalf of major pharmaceuticals and the obstruction of the development of new, better and affordable drugs. On the whole; the present system of the financing of medical innovation is manifestly unfair, wasteful, ineffective and undermines the right to health of Greeks and Europeans.

 

The goal should be to “delink” the incentives for research and development from the high prices of patented originator drugs. This can be achieved by setting up a fund for rewarding pharmaceutical innovation to which EU Member States will contribute.This Fund will reward research efforts of private and public entities driven by health outcomes with a view to promoting further research for the benefit of patients. This way companies will be compensated for the costs of research, while the medicinal products will be available in free competition with generics.  To this end, drug approval will be under the strict supervision of European and national authorities to ensure the quality .

 

This is something not unheard of. Under pressure from patients’ associations , health professionals and activists, such proposals have long been discussed at the World Health Organization and the U.S. Congress. The proposed system is much fairer providing a) lower prices and access to life-saving treatments while b) reducing costs for healthcare providers. Finally, it is far more efficient, since it seeks to serve real health needs and not artificial ones created by companies’ marketing strategies.

 

Europe must prioritise the right of patients to the drugs they need over the right of companies to a monopoly. Today, it is more pertinent than ever. In today’s Greece, where patients literally fight for their lives; their call should be heard across Europe; human rights are more important than multintionals’ intellectual property rights.

 

Health is the most critical, but not the only sector where large companies impose their rule by force of intellectual property rights. In recent years the proliferation of IPR in many unrelated fields, from seed growers to software developers and from cultural projects to any kind of scientific achievements; the product of human creativity is captured by large companies using IPR monopolies. Society is thus deprived from the most valuable good in the era of information: free access to knowledge.

 

Proponents of strict patents laws overlook the fact that in science, as in arts, there is no parthenogenesis. The essence of human progress is to copy and modify previous works in order to improve them. Moreover, major scientific achievements rarely are the result of profit-oriented research. These are most often achieved ??by individuals or groups with humanitarian motives experimenting freely with the works of their predecessors. The global free software community that produces innovative and reliable products pro bono capitalizing on existing knowledge without restrictions is another tangible proof. The same was true in the 17th century when Sir Isaac Newton gave credit to Galileo and Kepler, saying : “If I saw farther , it is because I stepped on the shoulders of giants.”

 

Large multinationals attempt to go against the tide of the dynamism we experience today by trying to control, manipulate and direct intellectual property through legislation. During the ongoing negotiations for the new Transatlantic Free Trade and Investment Partnership Agreement (TTIP), the EU should stay away from instituionalising the demands of industry. There should be a new set of rules which will foster innovation and creativity where access to knowledge will be governed by the principles of freedom, justice and equity .

 

EP Elections pledge: Europe for access to medicines and public health care

10 commitments for candidates to the European Parliament

1. Defend universal access to public health care systems without discrimination for reasons of economic capacity, employment status or nationality. Support the principle of the integration of health aspects into all European policies. Call upon the intervention of the European Commission if the right to health is violated, especially in countries affected by EU mandated public debt reduction policies.
2. Demand the carrying out of an independent health impact evaluation before any substantial financial cut-backs of public health systems when they occur within the context of EU supported austerity measures.

3. Support the creation of a EU fund for health-care solidarity to help EU member states where a hight number of people remain without health-care coverage as a result of EU mandated austerity measures.

4. Promote transparency and public access to data from all clinical trials for existing and new biomedical products.

5. Foster EU cooperation on health technology assessment and promote the use of transparent, unbiased, and robust methodologies to measure the effectiveness and added value of new medicines and technologies

6. Ensure the effective application of the EU Research Programme Horizon 2020 provisions that mandate open access policies for scientific articles and data generated from research financed with EU funding. Support EU policies such as innovation prizes that promote de-linkage between biomedical R and D costs and the price of new medicines.

7. Call for for a new binding EU regulation that demands transparency and full disclosure of the economic relationship between doctors and the pharmaceutical industry.

8. Defend strict EU norms in favour of socially responsible licencing policies for biomedical innovation that has received EU funding.

9. Support the issuing of compulsory licences to guarantee the affordable access to very high-priced life-saving drugs with great evidence of efficacy, such as the case of a treatment against hepatitis C and a few anti-tumoral medicines.

10. Promote fair and equitable EU international trade and development policies that facilitate universal access to essential medicines and that support strong EU funding for research on “neglected” and tropical illnesses that tend to affect countries of the Global South.

Send your support to: david@davidhammerstein.org and teresa.salinas@saludpordercho.org

Declaration written and coordinated by Working Group on Health, Medicines and Innovation (GTSMI), TransAtlantic Consumer Dialogue,  Salud Por Derecho saludporderecho.org, Médicins du Monde, Spain, Pharmacists without Borders, Spain,  Confederation of Consumers and Users, Spain, and No Gracias, among other groups and individuals.