“It is not healthy: Mending the broken medicines innovation model”


European Parliament (room JAN 6Q2), 2 December 2015, 13:00-15:00


We would like to invite you to the conference “It is not healthy: Mending the broken medicines innovation model” under the auspices of MEPs Marian-Jean MARINESCU (EPP, RO), Nessa CHILDERS (S&D, IE), Fredrick FEDERLEY (ALDE, SE – tbc), Lola Sanchez CALDENTEY (GUE/NGL, ES) with the support of the TransAtlantic Consumer Dialogue (TACD), the European Public Health Alliance (EPHA), Médecins du Monde (MdM) International network, Universities Allied for Essential Medicines (UAEM Europe), Salud Por Derecho in collaboration with the European Parliament Working Group on innovation, access to medicines & poverty-related diseases.

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: 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 (13:00-15:00, room JAN 6Q2)

Welcoming remarks by sponsoring MEP

What is the diagnosis for our medical innovation and medicines pricing ills?

Introduction by sponsoring MEP

Moderated by Yannis Natsis @ynatsis, advocacy advisor on access to medicines, TACD 

  • Xavier Prats Monné, Director-General, DG SANTE, European Commission (to be confirmed)
  • Teresa Alves, International Policy Adviser, La Revue Prescrire
  • Dr. Fernando Lamata, @LamataF, Consejería de Sanidad de la Comunidad de Madrid, Madrid, Spain – member of the EC’s Expert Panel Working Group on access to health care
  • Dr. Antje Haas, Head of our pharmaceuticals department, GKV-Spitzenverband

Q&A session

What are some of the possible cures for our ailing and expensive pharmaceutical model?

Introduction by sponsoring MEP

Moderated by David Hammerstein @DaHammerstein, senior policy advocate, TACD

  • Rachel Kiddell-Monroe, @Access2Rachel Special Advisor to Universities Allied for Essential Medicines (UAEM) @UAEM
  • Dr. Bernard Pécoul, Executive Director, Drugs for Neglected Diseases Initiative (DNDi) @DNDi
  • Els Toreele, @ElsTorreele Director of the Open Society Public Health Program’s Access to Essential Medicines Initiative @osfHealth

Q&A session

Concluding remarks by sponsoring MEP

Please join the discussion on twitter using #unHealthy.

We would kindly ask you to register your attendance (please mention title & organisation represented) by sending an email to a2m.europe@gmail.com by Wednesday 25 November 2015.

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. Badges will be handed out at the “Altiero Spinelli” entrance of the European Parliament on Rue Wiertz 60 as of noon on the day of the event (please look for respective desk/poster).

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

EC Expert Panel proposes transparency, de-linkage and responsible licensing



Access to health

services in the European Union


approved this opinion for public consultation

by written procedure on 25 September, 2015

Public Consultation is open until November 8th, 2015

Expert Panel members

Pedro Barros

Margaret Barry, Helmut Brand, Werner Brouwer,

Jan De Maeseneer


Bengt Jönsson (Vice


Fernando Lamata

Lasse Lehtonen

Dorjan Maruši?

Martin McKee

Walter Ricciardi

Sarah Thomson

MEDICINES: p. 71 to 81 that includes this reference and the below recommendations.

The current system of funding R&D through medicine prices encourages

pharmaceutical companies to focus on areas likely to be most

profitable for them rather than areas in which there is unmet need.

The European Union could, however, find more effective ways of funding

R&D to meet health needs (Bloemen and Hammerstein 2012). An interesting line

of development would be to de-link prices and R&D costs (WHO 2012a; WHO

2012b). In 2010, Council Conclusions on the EU’s role in global health asked

Member Sates to explore this option and to ensure that EU investments in health

research secure access to the knowledge and tools generated as a global public

good and generate socially essential medical products at affordable prices.

Preliminary opinion:

The European Union can support

Member States in the following ways:

Promote joint action to develop a

strategy to ensure equitable access to new

medicines and new innovative treatments and fairer prices.

Promote transparency to ensure that patents serve the social purpose for which

they were created. This requires detailed knowledge of costs and prices. Wthout this information there is a risk of patent misuse.

Evaluate the possibility of

withdrawing patents in cases of misuse.

Consider setting up a European Parliament committee to analyse the prices of new

medicines. The committee should be guaranteed transparency around costs and prices.

Review the impact of the Supplementary Protection Certificate in ensuring access

to medicines (De Boer 2015).

Link products that have benefited from EU funds such as Horizon 2020 to socially

responsible licensing.

Explore models to separate the cost of R&D from prices (Council Conclusions May

10, 2010) and extend these to EU countries (not just low

income countries).

Evaluate and promote the use of joint procurement mechanisms.

Decouple the financing of EU regulator

y agencies (the European Medicines Agency,

EMA) from the pharmaceutical industry. Currently, 83% of the EMA’s budget comes

from the industry via authorisation fees).

Introduce stricter control over conflicts of


Guido Rasi, executive director of European Medicines Agency in Eurpean Parliament

All diseases “rare” to evade regulation.

No data on elderly polymedicaton or women specific med impacts.

“There is an attempt to circumvent EMA regulations for the approval of new drugs by making every disease a rare one”, in order to take advantage of fast-track approvals with fewer requirements of clinical trials and provision of data on the efficacy and safety of new medical products.

Rasi was questioned by Spanish Socialist Soledad Cabezón on why the EMA did not evaluate the quality of the medicines compared with those already on the market. She also asked whether the EMA had any plans on making transparent the R and D costs of new medicines as well as improving clinical trial transparency for the sake of health technology assessment. Rasi responded by stating that “commercial” questions were not the competence of the EMA but of the member states. Rasi added that EU member states were capable of evaluating the cost-benefit of the new products if they used their resources wisely.

When asked about TTIP Rasi said that he was not following this issue in detail.

MEP Nessa Childers asked Rasi about the impact of medicines on the elderly and women.

Rasi stated that “We don´t have data or a clear scientific model on the inter-action of the many drugs that elerly people take at the same time. The same goes for women who undergo hormonal changes as they get older that changes the way they react to medicines.” He hoped new research with help. Rasi added that “personalized medicine with surrogate indicators” could be a big help to solve the problems of the elderly and women.

State of play of EU Marrakesh Treaty Ratification


The false competence issue to ECJ

In July the European Commission sent a legal consultation to the European Court of Justice on the issue of whether the Marrakesh Treaty should or should not be ratified under the exclusive competence of the European Union. The reason the EC finally sent the consultation was to prevent a few individual EU member states from ratifying on their own. The ECJ opinion could take between 9 and 18 months but this does not prevent the Council of EU Ministers from ratifying the Treaty at any time. The European Parliament legal service has submitted to the ECJ its very clear opinion in favour of EU exclusive competence along the same lines as the Commission and the Council legal services have expressed. There is no doubt that the Court will rule it is the EU´s exclusive competence to ratify. The consultation can also be seen as a delaying tactic to divert attention from the blockage in the Council.

“Marrakesh Directive”

The other related news is that the European Commission is preparing a “Marrakesh Directive” to better implement the Treaty. The proposal that we hope will be practically a “copy-paste” of the Treaty will probably be out in December. It should be stressed that this is not at all a pre-requisite for ratification and, if it were necessary, could have been done after ratification. As well, the approval of a “Marrakesh Directive” will not in any way change the opposition of some Member States on the competence issue. Nevertheless, we must be alert about the content of this proposal to make sure it has the most favourable interpretation of the Treaty.

German blocking of Treaty

Treaty ratification is now supported by 21 of 28 EU Member States. If Germany changed its negative position, the “blocking minority” in the Council would probably collapse. This calls for political pressure on a political level in Berlin, both in the Justice Ministry and with political parties. To date very few people in the German Government and the Bundestag know anything about Germany´s blocking of the Treaty by using very dubious and totally unsubstantiated arguments: that it is not EU competence, that we need to change German copyright law first and that we need a new EU Directive first. All legal expert have told us the contrary. This is obviously a deceitful political ploy that needs to be exposed. Italy is using the same arguments. The UK´s position on competence is more of a result of the general “euro-skeptic” political ambience.

European Parliament takes action

In the last few weeks both the Legal Affairs Committee and the Petitions Committee have responded positively to the requests of the European Blind Union. Both have decided to send a letter via Martín Schulz, the European Parliament President, to the Luxembourg Presidency of the Council and to Donald Tusk(with copy to Member States), the permanent President of the Council, requesting immediate ratification of the Treaty. We shall circulate the texts when we gain access to them. Other measures, such as a resolution in the EP plenary and a press oriented event have also been requested by the EBU representatives to the Petitions Committee and we are awaiting a reply.

EU pushes stronger copyright in TTIP but no exceptions in public interest

Based on intervention made for TACD at TTIP stakeholders plenary July 15th in Brussels

With a clear lack of balance in its approach the EU position in the TTIP negotiations asks for more copyright protections for the renumeration of broadcasters and rights holders but makes no mention of the needs of public interest exceptions for libraries or people with disabiities.

“On copyright, in the EU flagged  the following priorities as areas of offensive interest in the TTIP negotiations: 1) remuneration rights for broadcasting and communication to the public (public performance) for performers and producers in phonograms, 2) a full right of communication to the public (public performance) for authors in bars, restaurants and shops and 3) a resale right for creators of original works of art (Source:EU Position Paper on Intellectual Property, March 2015).” http://keionline.org/node/2281

Sorely missing from this one-sided rights-holder perspective is support for the Marrakesh Treaty for Visually Impaired Persons that permits the cross-border sharing of materials formatted for blind persons around the world. Surprisingly, this copyright and human rights treaty has still not been rartified by the European Union. TTIP could be an opportunity for both the US and the EU to assure swift ratification and implementation of the Marrakesh Treaty.

While the EU is energetically supporting in TTIP and at WIPO a very questionable new layer of copyright protection for broadcasters and their transmissions on the internet (not the content!), it is opposing internationally at WIPO and ignoring in TTIP any progress toward providing copyright flexibilities for the public interest role libraries carry out for preservation and dessemination of science, culture and education.

This monochrome EU copyright strategy for TTIP reflects a total lack of equilibrium between IPR protection and the right to culture of consumers and citizens as a whole.

TTIP and pharmaceuticals: possible side-effects

From presentation by TACD at TTIP stakeholders event on July 15th, 2015

 At TACD we are afraid that while some proposals on the table are positive, others could chill future reform or lock us in old business models of biomedical innovation that could work against the common good, affordable medicines and transparency.

There are few proposals, some of which have been under discussion before TTIP, that are win-win propositions within EU-US cooperation, like the joint technical inspections of third-party installations or the sharing of data on pharmaceuticals. We support common- sensical cooperation on these kinds of issues that could save time and money.

At the same time we are concerned that new trade rules could trump some important public health and affordable access guarantees.

We sincereley hope that pricing and reimbursement procedures being considered in TTIP are not adopted by the negotiators. These measures would force Governments to have to give cumbersome justifications for choosing a less expensive medical product. EU member states should not have to jump through torturous hoops or have short time deadlines to decide on drug procurement pricing or purchases. See: http://www.beuc.eu/publications/drug-pricing-and-reimbursement-decisions-have-no-place-ttip/html

The elements that constrain governments from choosing the best and most affordable medicine for procurement, that are present in other free trade agreements, such as the EU-Korea FTA, should not be in TTIP. Governments should not be under  pressure to buy medicines without proof that they work (often important information is precisely hidden as commercially sensitive).

TACD is also worried that new trade secret and commercial confidentiality rules included in TTIP could limit clinical trial transparency and inhibit or chill future open innovation models for affordable, accessible and effective medicines. As well, extending commercial confidentiality through trade secret rules could hurt the sharing of scientific data in open innovation, limit transparency of biomedical R and D investments and block key life-saving information on the safety and efficacy of medical products.

Another important cross-cutting issue in TTIP that could also impact access to medicines is investor protection or ISDS(investor-state dispute scheme). ISDS allows investors to challenge sovreign decisions by Governments and, whether these challenges are successful or not, could chill future legisaltion for affordable and innovative medicines in the EU and US. This specially affects the patentability of new medicines, trademarks, transparency and other public health issues. For example, ISDS has permitted a 500 million dollar case brought by Lilly against Canada because Canadian courts rejected a number of patents for their products. It is concerning that tobaco companies are using ISDS against public health laws on plain packaging of cigarrettes.

TACD is also against any proposals in TTIP that would mean the prolongation of patent monopolies over biomedical products such as the proposal to extend patent protection for biological drugs which would mean significant delays in the access to affordable generic mediciines.

While EU-US could produce many consumer-friendly results, we are concerned that EU-US regulatory cooperation institutionalized in TTIP that would consider new legislation on both sides of the Atlantic could mean that phamaceutical policy will be subject to even greater industry lobbying and that any new legislation could be greatly slowed and influenced. The proposed Regulatory Cooperation Council could have the secondary effects of regulatory chill and even greater lobby power in favour of corporate capture of policy given the disfavourable relationship of forces between industrial interests and the public health interest of consumers and citizens.

With pharmaceuticals on the table during this week’s TTIP negotiations, we expect negotiators to consider that most of these decisions should be an exclusive competence of national governments and have no place in an EU-US trade deal, especially if these measures could mean more problems for the affordability, efficacy and safety of our medicines.

For more detail and information please see: http://test.tacd.org/wp-content/uploads/2014/01/TACD-IP-15-13-IPR-in-the-Transatlantic-Trade-and-Investment-Partnership.pdf http://www.beuc.eu/publications/beuc-x-2015-064_ipa_ttip_health_beuc_position.pdf and http://tacd.org/wp-content/uploads/2013/09/TACD-IP-Resolution-on-access-to-medicines.pdf

Europolitics: WIPO Marrakesh Treaty: Long road to ratification

Campaigners hope that a year after signing, the member states blocking its ratification will back down
By Mari Eccles • 25 June 2015
Few would argue about the worthiness of the Marrakesh Treaty.

Signed by the EU in June 2014, it focuses on copyright exceptions to allow greater distribution of books in formats accessible to visually impaired citizens.

The treaty has cross-spectrum support: a debate calling for ratification at the European Parliament on 24 June was sponsored by members from the left, right and centre, while the President of the European Blind Union, Wolfgang Angermann, calls greater access to such material “a human rights issue”.

Why then, has the treaty not been ratified?

Blocking in Council
Although few publicly oppose the Marrakesh Treaty, seven EU states – three of which have been confirmed as Germany, Italy and the UK – have formed a minority block in the Council and rejected a compromise proposal drawn up under the Latvian Presidency on the conclusion of the treaty.

Four other member states are thought to have sided with them, with EU sources hinting that the Czech Republic and Hungary may be among them.

Sources say that while these member states may not oppose the substance, they are worried about the EU claiming more and more exclusive competence when it comes to international treaties, fearing that this could lead to a ‘slippery slope’.
Campaigner David Hammerstein of the Transatlantic Consumer Dialogue, who moderated the event in Parliament, said their argument over EU competence has been refuted by legal experts.

He said: “It is a very sad commentary about the state of EU affairs if legally baseless competence excuses are used to punish blind persons. The blocking of the treaty is not at all about competence issues: it is about the politically blind incompetence and insensitivity of a few big member state bureaucrats.”
He believes the key to unblocking the dossier in Council is to gain the support of one big member state, such as Germany, whose influence could have a domino effect.

There is also momentum coming from MEP Julia Reda’s copyright report, which advocates swift ratification and which will be voted on in July’s plenary in the European Parliament.

Role of the Commission
The European Commission is also working behind the scenes to get things moving, with representatives from the cabinets of Commissioners Andrus Ansip and Günther Oettinger expressing confidence that ratification could go ahead under the Luxembourg Presidency, although EU sources believe it is too early to say whether the treaty will be prioritised in the coming months.

Speaking privately to Europolitics, disability campaigners say they fear the treaty could be swept aside as focus turns to the more attention-grabbing elements of the digital single market strategy, such as geo-blocking.
While the Commission is working on compromises it hopes will appeal to the remaining seven member states in an attempt to “unblock” the dossier in Council, it seems reluctant to go to the EU Court of Justice, a representative citing this as a last resort.

Campaigners also see this option as time-consuming, unlikely to conclude before 2017, but having waited one year since signing by the EU (and two years for some member states), this route – likely to conclude in the result they want – is becoming more attractive.

Preservation in archives and libraries: Better dead than read?



Is our cultural and historical heritage better dead that read? Or is the preservation of our common past a public good that is much better read than dead? If we do not take urgent action much of that legacy will be either lost forever or will remain effectively dead because it will not be accessible to most of the people to enjoy, study or research. Despite living in a digital age some in this room are still defending an information and innovation strategy of scarcity in stark contrast to building socially useful online abundance.

The vast majority of representatives in this room consider preservation a moral and public service responsibility to take international legal measures to preserve our cultural and scientific heritage in the digital environment.

Nevertheless, the complex and incomprehensible jungle of often irrational current copyright laws makes it almost impossible for librarians and archivists, most of whom are not IPR lawyers, to fulfill this responsibility internationally, in cross-border operations with any degree of legal certainty. Should they take the risk of being sued? Here common-sensical social practice conflicts with archaic, chaotic copyright laws that is causing cultural “preservation chill”.

Is it logical or acceptable not to allow legal cross-border shipment archived works? Why is an international solution needed to solve the problem?

An international exception to copyright is needed to permit the supply by one library or archive of a copy of a work to replace a copy of that work that had been preserved in the receiving library or archive but that has now been lost, detiorated or destroyed. An international copyright flexibility is also needed for academic and journalistic researchers to easily access archives and libraries around the world for the common good of advancing science, strengthening freedom of information and restoring cultural equity between countries of the North and the South.

Consumers are overwhelmingly in favour of international cooperation in cultural preservation and sharing of that knowledge.

Broadcasting Treaty: will protecting broadcast signals threaten the Internet?


There is a very strong push for convening a diplomatic conference to approve the Broadcasting Treaty of the World Intellectual Property Organization at this week´s Standing Committee on Copyright and Related Rights in Geneva.

At stake is the freedom to share cultural material on the internet, the concentration of power of large incumbent broadcasters and in general opening up with yet another absurd layer of copyright protection of a pandora´s box of new abuses and threats to digital rights and access to knowledge.

The EU and the US have different approaches to the Broadcast Treaty. While the EU is pushing for the convening of a diplomatic conference to approve a Treaty with a broad scope, the US is in no hurry and would prefer an international legal instrument with a narrow scope. Most of the countries of Asia, Latin America and Africa are not at all enthusiastic about this treaty and instead would appreciate a Library Treaty to facilitate the public mission of lending, sharing and preservation by means of exceptions and limitations.

The EU represented by the European Commission is the main force pushing for a broadcasting treaty (despite the fact that practically no one in the European Parliament know even about the existence of this proposal) more than ever to add another level of copyright protection for “traditional” incumbent broadcasters from “piracy” of their programs, specially on the internet, including “deferred” or “post-fixation” use of any broadcast. This could mean opening up great threats for digital rights and access to culture.

The US only wants a “Single right” that protects broadcasters from piracy of direct “simultaneously or near simultaneous” broadcast signals, like a live sporting event. Which means no extra protection of later use of the broadcast on the Internet.

India is also against any attempt to include webcasting, simulcasting or anything that is not live broadcasting. Broadcasters should not be given any new rights in other platforms. They should not be given any “blanket rights” nor “post-fixation rights”. If we have a treaty India supports clear exceptions for education, non-commercial use and other public interests.

EU Trade Day: Is trade about our values or “zombie deals”?

EU TRADE DAY: Do trade agreements represent the forward march of “EU values” or are they “zombie deals” against the public interest?

EU Trade Day #EutradeDay took place on June 23rd organized by the Directorate General of Trade of the European Commission and attended by over 500 representatives of businesses, NGO´s, consumers and trade-unions. There was a plenary session led by EC Trade Commissioner Cecelia Malmstrom and ten parallel break-out sessions that covered many diverse issues. Commisioner Malmstrom said that trade was one of the key ways the EU extends its social, economic and environmental values around the world and that these agreements should be carried out with a “bottom-up” approach with the wide participation of civil society. One of the main objectives of the day was to collect ideas for the EU´s new Trade Strategy that will be published in October of this year. (See BEUC position: http://www.beuc.org/publications/beuc-x-2015-060_consumers_at_the_heart_of_trade_policy.pdf )

The General Secretary of the Trade Union Council Francis O’Grady broke the ice by flatly stating that “zombie trade deals that are not in the public interest should be rejected” and concretely on the ISDS debate: “”The row in the European Parliament over foreign investor privileges in the EU-US trade deal proves that old-style Investor State Dispute Settlement is dead – no one supports it any more, on the left, on the right or in the Commission. And yet, zombie-like, it lives on in the Canada- EU deal, unreformed, unamended, and unacceptable.”

On the other side, the Eurochambre business representative and other industry leaders at the session on “How trade affects peoples lives”, insisted that “international trade has always been an important driver of progress by creating jobs, by benefitting EU companies and through promoting economic development in South.” Business Europe was convinced that “China has an increasing portion of world trade and as result is experiencing more evolution, more innovation and more competition.” Little mention was made by these representatives of how trade affects peoples lives.

French economist Messerlin stated that the “EU made a big mistake by putting talks over regulations under a trade agreement as opposed to direct ongoing transatlantic talks between regulators of US and EU”. He also said that many economists have doubts about including intellectual property protection in trade agreements because this means granting new temporary economic monopolies. He insisted that one thing was open trade and something else was regulatory harmonization, much of which will never happen between the US and the EU. One civil society attendee summed it up: “Today I learned that international trade is not about international trade.”

Many speakers voiced opposition to higher regulatory standards in trade agreements with countries of South because it would make it harder for them to compete on the world market. Many industry and Commission representatives referred to the trickle-down effect of international trade that ends up benefitting the majority by creating jobs.

Concern was expressed by some experts and Ngos of the possible regulatory chill effect trade agreements can have on public health measures to assure access to medicines, food safety and protection from toxic chemicals. In the case of locking in the high price of medicines the representative of Merck Pharmaceuticals responded that the principal problem was the lack of infrastructures and hospitals and not the high price of medicines often backed by rules included in trade agreements.

A number of civil society representatives and experts complained that while the purely economic aspects of international trade agreements and WTO rules had binding mechanisms for compliance while consumer rights, public health, environment and labour rights did not have equivalent enforcement measures.

In general, while many in the European Commission and industry representatives stated that the promotion of trade is usually a win-win situation in which the common good in health, environment and consumer rights are benefitted by expected economic growth and more jobs, there was also great concern among many citizens organizations that large economic interests influencing trade can easily trump greater public interest objectives.

EU Trade Day is the latest in a series of participatory events on trade as part of the recent “charm offensive” to show that the EU wants truly “bottom-up” approach to trade. But it still remains to be seen if civil society opinions will be decisive in the future of EU international trade negotiations and agreements.