FROM A DISGRACEFUL “BALANCE” TO THE JUSTICE OF A COMMON GOOD

 

 

 

Opening intervention of TransAtlantic Consumer Dialogue at WIPO Diplomatic Conference for Visually Impaired Persons in Marrakesh

 

 

“Balance” is one of the words most commonly used during the discussions of a Treaty for the Visually Impaired. Many delegates at this diplomatic conference speak of achieving “balance” between the needs of millions of blind and other print disabled persons and the rights of copyright holders. But this Treaty is not about balance but instead about correcting the enormous, immoral and historic imbalance between blind persons who are deprived access to culture and education and a publishing industry that already has many laws that protect it, between most sighted persons who can access millions of books and the visually impaired who have been deprived of many of the benefits of the information technology revolution.

 

 

This Treaty must be about repairing injustice instead of creating new restrictive global copyright enforcement laws through the backdoor, about eliminating blatant human rights discrimination instead of a biased imposition on the poor global South of technical protection measures, commercial availability clauses and anti-fair use “three step test” amendments. It is true: some entertainment industry lobbyists are trying to cynically use the visually impaired Treaty as a vehicle for building strong barriers against any future global copyright reform. If not, why are there so many movie industry and other audio-visual industry lobbyists present here today?

 

 

To the contrary, establishing new global norms for copyright exceptions for the visually impaired is an attempt at injecting a doses of common sense into the copyright system, an old regime that is very ill-adapted to the digital age. It is a way of even helping to legitimize a system that has an increasingly low level of social acceptance.

 

 

Over the past few months we have heard from industry representatives that allowing blind persons to have easy access reading material on a non-profit basis could “severely weaken international copyright law”. Even some EU and US representatives have been carried away by this neurotic paranoia of potential piracy that has never been substantiated by any empirical evidence.

 

 

The shameful double-standards of the EU and the US is specially stunning. While the US and most EU member states have clear, simple and easy to use national exceptions to copyright for the visually impaired, both the EU and the US refuse to accept the extension of these rules to the rest of the world. If a set of laws have worked fairly well in the US and European, why are they not valid globally? Instead, both the EU and the US want to add multiple layers of restrictive complications that go far beyoond their own laws into an international law for the visually impaired. The US doesn´t want to hear of “fair use” or “fair practices” in the Treaty while both terms are prevalent in the US legal copyright system. While there are no commercial availability clauses neither in the US nor in most of the EU, both want to enshrine this very complicated rule into the global Visually Impaired Treaty.

 

 

There has also been a clear democratic deficit and lack of transparency on the part of the EU in this discussion. The EU´s tough negotiating positions against many of the Word Blind Union´s proposals are in stark contrast to the positions and declarations of Europe´s democratic representatives in the European Parliament that have repeatedly supported a robust, uncomplicated and human rights oriented Treaty for the Visually Impaired. Unfortunately, until today the disgraceful and obstructive negotiating postures of the EU have been forged behind the closed doors of the EU Council where the narrow industrial interests of a few have taken priority over the common good of many.

 

 

This conference will only be successful if it is strongly supported and considered useful by its beneficiaries, millions of visually impaired represented by the World Blind Union. Any other result would be totally irrational. Failure is not an option.

 

 

David Hammerstein, TACD

 

 

 

 

 

 

El voto de ayer en bruselas y la campaña contra el secretismo médico

El NUEVO REGLAMENTO EUROPEO DE ENSAYOS CLÍNICOS SOBRE HUMANOS

Voto de ayer sobre la transparencia biomédica: lo bueno, lo malo, lo incierto

La presión ciudadana ha sido un éxito parcial en la lucha para la transparencia y ahora debe centrarse en los Estados miembros de la UE que negociará el texto definitivo con el Parlamento.

La confidencialidad comercial: una de cal, una de arena

Si bien es cierto que fue derrotada por una estrecha margen la enmienda legislativa consolidada 40, sí que fue aprobada enmienda consolidada 41 como un recital a pesar de una masiva presión farmacéutica contra. Ambas hablan de no utilizar la confidencialidad comercial como una razón para ocultar los datos de ensayos clínicos. En otras palabras, no existe un dictamen del Parlamento que la autorización de los datos de ensayos clínicos post-mercado deben ser públicos. Además, ITRE 61 también se aprobó que apoya las directrices europeas de Agencia Europea de Medicinas en contra de la excusa de la confidencialidad comercial, precisamente una de las razones por las grandes farmacéuticas están desafiando la EMA en el Tribunal Europeo de Justicia. Todo junto puede dar una interpretación a favor de la transparencia de las otras partes del texto que el Parlamento debe ahora negociar con el Consejo de los Estados miembros de la UE. Por lo tanto, se podría argumentar que el Parlamento considera que no hay datos comercialmente confidenciales en datos de ensayos clínicos posteriores a la autorización de un medicamento.

Requisitos más exigentes para datos públicos

Se ha producido un fortalecimiento de los datos requeridos en los resúmenes de los ensayos clínicos que no han sido autorizados y la exigencia de la publicación de un informe completo los datos clínicos, una vez se autorizan los medicamentos.

Ensayos clínicos comerciales, no comerciales y “de bajo riesgo”

Hay muchos menos requisitos con respecto a la notificación de los resultados de los ensayos clínicos no comerciales o académicos. También hay algunos requisitos para los llamados “ensayos de bajo riesgo”, a menudo con los ensayos de los medicamentos ya autorizados. Existen una preocupación fundada acerca de las definiciones poco claras de una pruebas “no comerciales” y “ensayos de bajo riesgo” y el posible abuso de estas excepciones a información sólida.

Acceso a todos los ensayos: el vaso está medio lleno o medio vacío?

Aunque las empresas serán obligadas a publicar muchos más datos clínicos que en la actualidad, todavía estamos muy lejos de “todas las pruebas, todos los resultados”. No hay requisitos obligatorios para la publicación de datos en bruto en el Reglamento. También hay mucha ambigüedades en la propuesta ley y hay muchas lagunas en las definiciones en el el texto que podrían ser aprovechadas por las grandes farmacéuticas.

Clinical Trial Vote: the good, the bad, the uncertain

 

Citizen pressure has made a big difference for transparency and must now focus on EU member states who will negotiate final text with Parliament.

 

First non-technical short reaction to Clinical Trial Regulation vote on transparency issues. 

 

  1. Commercial confidentiality

 

 

While it is true that consolidated legislative amendment 40 was not adopted, consolidated amendment 41 with the same wording was approved as a recital despite massive big pharma lobbying against it. Both speak of not using commercial confidentiality as a reason for concealing clinical trial data. In other words, there is a Parliament opinion that post-market authorization clinical trial data should be public. Furthermore, ITRE 61 was also adopted that refers to European Medicine Agency guidelines on commercial confidentiality, precisely one of the reasons big pharma is challenging the EMA in the European Court of Justice. This can lend a pro-transparency interpretation of other parts of the text as the Parliament must now negotiate the final text of the law with the Council of EU member states. Therefore, it could be argued that the Parliament feels that there is no commercially confidential data in post authorization clinical trial data.

 

 

  1. More robust data requirements

    There has been a strengthening of the data required in summaries of clinical trials that have not been authorized and the requirement of the publication of a clinical trial report on clinical data once a drug is authorized.

 

 

 

  1. Commercial, non-commercial and “low-risk” trials

 

 

There are significantly fewer requirements with regards to reporting results for non-commercial or academic clinical trials. There are also few requirements for so-called “low-risk trials”, often with trials on medicines already authorized. There are significant concerns about the not very clear definitions of a “non-commercial” trials and “low-risk trials” and the possible abuse of these exceptions to robust reporting.

 

4. All Trials: the glass is half full or half empty. While significantly more data will be required to be published than at present we are still a long way from “all trials, all results”. No complete raw data publication requirements are in the Regulation and there seem to be many loopholes that might be used by Big Pharma.

 

 

 

Access to medicine in Greece: 10 tendencies on the ground

Access to medicine in Greece:

 

 

Some elements to evaluate the situation on the ground

 

 

1. There exists an access to medicine problem in Greece. Over the last three years of austerity measures and economic crisis significant portions of the population have been excluded from adequate health-care and medical treatments.The introduction of strong measures of co-payment for important medicines is also a cause of exclusion from key treatments.

 

 

2. There have been clear problems both on the supply side (lack of payment, parallel trade) and on the demand side with regards to the lack of rational use of medicines.

 

 

3. Structural problems in medicine market compared to most other EU states. There is still quite a large share of the market occupied by originator-patented drugs while the prices of generic medicines are still relatively high.

 

 

4. Low social acceptance of generic drugs. An important part of Greek public opinion question the quality of generic products and insist upon receiving originator brands. 

 

 

5. “Innovative medicines” are not being given price authorization by the Greek State and they often are not available.

 

 

6. Important lack of key medicines due to the unpaid debts by the Greek State and parallel trade that has led to stock shortages.

 

 

7. Some cancer treatments are specially insufficient with comorbidity being a major issue, as well as unaffordability of certain drugs, such as Herceptin, for breast cancer.

 

 

8. There is major health stress among the immigrant population due to their exclusion from most public health treatments.

 

 

9. There are indications of a major lack of coverage in the vaccination and other problems of health-care for children.

 

 

10. The State health system is increasingly economically unsustainable due to the high unemployment that limits revenue.

 

Write to your MEP now for clinical trial transparency – tomorrow vote at 10

Example of letter, sent by BEUC. Specially important  is for MEPs to support CONS 40 and 41 on “commercial confidentiality” that is being used as an excuse for Big Pharma secrecy.

 

Dear Member of the ENVI committee,

On 29 May you will be voting on amendments to the Commission Proposal for a Regulation on  clinical trials.

BEUC, the European Consumer Organization, welcomes all the efforts made so far by the European Parliament and asks you to supports all the proposed compromise and consolidated amendments as they significantly improve the Commission proposal especially with regard to ethics committee, transparency, informed consent and protection of the trials subjects.

In particular we would like to draw your attention on the issue of transparency and urge you to support CONS AM 40 and 41.

Recent drugs related scandals undermined consumers’ confidence in regulators and ultimately in the safety of the medicines. The vote is a unique opportunity to restore public trust and to bring more openness in the pharmaceutical sector.
Clinical trials results are useful not only for researchers and health professionals but also for the general public. Consumers, as patients, carers and potential users of medicines, want to be more involved in the decisions regarding their health and they have the right to access information on clinical trials. The disclosure of trials data empowers consumers and contributes to better quality of health care.
At present only half of clinical trials results are published and some trials are not even registered. Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for evidence based medicine and trials being repeated.
The volunteers taking part to a trial do so in the spirit of altruism and for the benefit of society therefore the results of the trials belong to them and to society at large : once a marketing authorization has been granted the clinical trials data should not be considered commercially confidential. The European Medicine Agency policy on transparency and access to documents should be upheld and reinforced.

We hope that you will take these elements into account during the vote and we remain at your disposal should you wish to discuss this further.

Your sincerely,

 

 

MEPs on the Environment, Public Health and Food Safety Committee

Title    Surname    Name    Country    E-mail    Party
Ms    KADENBACH    Karin    Austria    karin.kadenbach@europarl.europa.eu    Sozialdemokratische
Partei Österreichs
Dr    SEEBER    Richard    Austria    richard.seeber@europarl.europa.eu    Österreichische
Volkspartei
Ms    DELVAUX    Anne    Belgium    anne.delvaux@europarl.europa.eu    Centre Démocrate
Humaniste
RIES    Frédérique    Belgium    frederique.ries@europarl.europa.eu    Mouvement Réformateur
Dr    PANAYOTOV    Vladko
Todorov    Bulgaria    vladkotodorov.panayotov@europarl.europa.eu    Movement for
Rights and Freedoms
Dr    PARVANOVA    Antonyia    Bulgaria    antonyia.parvanova@europarl.europa.eu    National Movement for
Stability and Progress
Dr    CABRNOCH    Milan    Czech
Republic    milan.cabrnoch@europarl.europa.eu    Ob?anská demokratická
strana
Dr    OUZKÝ    Miroslav    Czech
Republic    miroslav.ouzky@europarl.europa.eu    Ob?anská demokratická
strana
Dr    POC    Pavel    Czech
Republic    pavel.poc@europarl.europa.eu    ?eská strana sociáln?
demokratická
Mr    JØRGENSEN    Dan    Denmark    dan.jorgensen@europarl.europa.eu    Socialdemokratiet
ROSBACH    Anna    Denmark    anna.rosbach@europarl.europa.eu    Løsgænger
Ms    HASSI    Satu    Finland    satu.hassi@europarl.europa.eu    Vihreä liitto
Dr    KORHOLA    Eija-Riitta    Finland    eija-riitta.korhola@europarl.europa.eu    Kansallinen Kokoomus
Ms    AUCONIE    Sophie    France    sophie.auconie@europarl.europa.eu    Nouveau Centre
Ms    BÉLIER    Sandrine    France    sandrine.belier@europarl.europa.eu    Europe Écologie
COCHET    Yves    France    yves.cochet@europarl.europa.eu    Europe Écologie
Ms    GROSSETÊTE    Françoise    France    francoise.grossetete@europarl.europa.eu    Union pour un
Mouvement Populaire
Dr    LEPAGE    Corinne    France    corinne.lepage@europarl.europa.eu    Citoyenneté Action
Participation pour
le 21ème siècle
PARGNEAUX    Gilles    France    gilles.pargneaux@europarl.europa.eu    Parti socialiste
Mr    GROOTE    Matthias    Germany    matthias.groote@europarl.europa.eu    Sozialdemokratische Partei
Deutschlands
Mr    FLORENZ    Karl-Heinz    Germany    karl-heinz.florenz@europarl.europa.eu    Christlich Demokratische
Union Deutschlands
Ms    KLASS    Christa    Germany    christa.klass@europarl.europa.eu    Christlich Demokratische
Union Deutschlands
Mr    KRAHMER    Holger    Germany    holger.krahmer@europarl.europa.eu    Freie Demokratische Partei
Mr    LEINEN    Jo    Germany    jo.leinen@europarl.europa.eu    Sozialdemokratische Partei
Deutschlands
Dr    LIESE    Peter    Germany    peter.liese@europarl.europa.eu    Christlich Demokratische
Union Deutschlands
ROTH-
BEHRENDT    Dagmar    Germany    dagmar.roth-behrendt@europarl.europa.eu    Sozialdemokratische
Partei Deutschlands
Dr    SCHNELLHARDT    Horst    Germany    horst.schnellhardt@europarl.europa.eu    Christlich Demokratische
Union Deutschlands
Dr    ULMER    Thomas    Germany    thomas.ulmer@europarl.europa.eu    Christlich Demokratische
Union Deutschlands
Dr    WEISGERBER    Anja    Germany    anja.weisgerber@europarl.europa.eu    Christlich-Soziale
Union in Bayern e.V.
Ms    WILS    Sabine    Germany    sabine.wils@europarl.europa.eu    DIE LINKE.
Mr    ARSENIS    Kriton    Greece    kriton.arsenis@europarl.europa.eu    Panhellenic Socialist
Movement
Dr    SKYLAKAKIS    Theodoros    Greece    theodoros.skylakakis@europarl.europa.eu    -
BOKROS    Lajos    Hungary    lajos.bokros@europarl.europa.eu    Magyar Demokrata Fórum
Ms    CHILDERS    Nessa    Ireland    nessa.childers@europarl.europa.eu    Labour Party
Mr    BARTOLOZZI    Paolo    Italy    paolo.bartolozzi@europarl.europa.eu    Il Popolo della Libertà
Mr    BERLATO    Sergio    Italy    sergio.berlato@europarl.europa.eu    Il Popolo della Libertà
Ms    GARDINI    Elisabetta    Italy    elisabetta.gardini@europarl.europa.eu    Il Popolo della Libertà
PIRILLO    Mario    Italy    mario.pirillo@europarl.europa.eu    Partito Democratico
ROSSI    Oreste    Italy    oreste.rossi@europarl.europa.eu    Lega Nord
TATARELLA    Salvatore    Italy    salvatore.tatarella@europarl.europa.eu    Futuro e Libertà per l’Italia
Dr    ŠADURSKIS    K?rlis    Latvia    karlis.sadurskis@europarl.europa.eu    Pilsonisk? Savien?ba
Ms    MORK?NAIT?-
MIKUL?NIEN?    Radvil?    Lithuania    radvile.morkunaite-mikuleniene@europarl.europa.eu    T?vyn?s s?junga -
Lietuvos krikš?ionys
demokratai
GERBRANDY    Gerben-
Jan    Netherlands    gerben-jan.gerbrandy@europarl.europa.eu    Democraten 66
Mr    EICKHOUT    Bas    Netherlands    bas.eickhout@europarl.europa.eu    GroenLinks
Ms    de LANGE    Esther    Netherlands    esther.delange@europarl.europa.eu    Christen Democratisch
Appèl
LIOTARD    Kartika
Tamara    Netherlands    kartikatamara.liotard@europarl.europa.eu    Onafhankelijk lid
Mr    CYMA?SKI    Tadeusz    Poland    tadeusz.cymanski@europarl.europa.eu    Solidarna Polska
HIBNER    Jolanta
Emilia    Poland    jolantaemilia.hibner@europarl.europa.eu    Platforma Obywatelska
SONIK    Bogus?aw    Poland    boguslaw.sonik@europarl.europa.eu    Platforma Obywatelska
Ms    ESTRELA    Edite    Portugal    edite.estrela@europarl.europa.eu    Partido Socialista
Ms    ANTONESCU    Elena
Oana    Romania    oana.antonescu@europarl.europa.eu    Partidul Democrat-Liberal
SÂRBU    Daciana
Octavia    Romania    dacianaoctavia.sarbu@europarl.europa.eu    Partidul Social Democrat
Dr    T?N?SESCU    Claudiu
Ciprian    Romania    claudiuciprian.tanasescu@europarl.europa.eu    Partidul Social Democrat
Ms    MAZEJ
KUKOVI?    Zofija    Slovenia    zofija.mazejkukovic@europarl.europa.eu    Slovenska demokratska
stranka
Dr    AYUSO    Pilar    Spain    pilar.ayuso@europarl.europa.eu    Partido Popular
Dr    GUTIÉRREZ-
CORTINES    Cristina    Spain    cristina.gutierrez-cortines@europarl.europa.eu    Partido Popular
PERELLO
RODRIGUEZ    Andres    Spain    andres.perellorodriguez@europarl.europa.eu    Partido Socialista
Obrero Español
Mr    SCHLYTER    Carl    Sweden    carl.schlyter@europarl.europa.eu    Miljöpartiet de gröna
Ms    WESTLUND    Åsa    Sweden    asa.westlund@europarl.europa.eu    Arbetarepartiet -
Socialdemokraterna
Ms    ANDERSON    Martina    UK    martina.anderson@europarl.europa.eu    Sinn Féin
Mr    CALLANAN    Martin    UK    martin.callanan@europarl.europa.eu    Conservative Party
Mr    DAVIES    Chris    UK    chris@chrisdaviesmep.org.uk    Liberal Democrats Party
Ms    EVANS    Jill    UK    Jill.evans@europarl.europa.eu    Plaid Cymru
Mr    GRIFFIN    Nick    UK    nick.griffin@europarl.europa.eu    British National Party
Ms    McAVAN    Linda    UK    linda.mcavan@europarl.europa.eu    Labour Party
Mr    NUTTALL    Paul    UK    paul.nuttall@europarl.europa.eu    UKIP
Mrs    WILLMOTT    Glenis    UK    glenis.willmott@europarl.europa.eu    Labour Party
Ms    YANNAKOUDAKIS    Marina    UK    marina.yannakoudakis@europarl.europa.eu    Conservative Party

TACD signed letter of withdrawal from Licences for Europe

http://www.libereurope.eu/sites/default/files/Letter_of_withdrawalL4E_TDM_May%2024_3.pdf

Cross-party MEPs demand that France supports strong WIPO Treaty for Blind

Lt – 22.05.2013 – A. Filippetti(1)

Alltrials asks you to write to MEPs on transparency vote

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

EU must save health of citizens, not just banks

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.

TEN KEY WORDS ON ACCESS TO MEDICINE IN THE EU

 

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.