One reason why Syriza won: the access to medicines crisis

by Yannis Natsis, TACD advocacy officer

Is there an access to medicines crisis in Greece? Yes, and if nothing changes radically, the worst is yet to come!!

This rather pessimistic note summarizes the state of public health in crisis-hit Greece as the country just elected a new government. Some overall macroeconomic figures may have improved but if one looks beyond the numbers, it is evident that the crisis is more present than ever. The public health sector has been particularly hit. It is true that in the pre-crisis era, important amounts of money were wasted in fraud and mismanagement as health is indeed a profitable business. The drastic horizontal spending cuts agreed and implemented in the context of the Troika-dictated policies have however created serious obstacles to peoples’ access to medicines and health services.

In Greece, health insurance is linked to one’s employment status. Since spring 2010 and the signing of the first memorandum of understanding with the country’s international lenders, the so-called Troika (the International Monetary Fund, the European Central Bank and the European Commission), unemployment skyrocketed to almost 30% in the general population and 60% among the youth. This means that over the past five years millions of people lost their jobs and more importantly lost their health coverage. There have been numerous public statements that put the number of the uninsured between 1.5 & 2.5 million in a country of 10,5 million. It is worth noting that national legislation guarantees some social protection for a maximum of two years following the end of one’s employment. But who are these millions of uninsured and what happens to them if they get sick? They mostly belong to the middle-class or what used to be the middle-class in the country; in other words, people in their 30s, 40s and 50s, SMEs’ owners, self-employed and others who were forced out of business while never reaching retirement age. It is important to remember that in many cases, losing their health coverage meant that their family members fell off the social safety net too. The younger generation is the second vast category of people who never managed to find employment and are regarded as chronically unemployed. Ironically, for the moment, the latter are better off thanks to their young age and good health. This probably explains why the consequences of the crisis on public health are not fully felt yet. There are nonetheless numerous worrisome signs that lead to the conclusion that the status quo resembles a time bomb waiting to explode.

Experts and people from the field such as pharmacists, patient groups, doctors, civil society stakeholders who have set up social clinics & pharmacies -another symptom of the crisis- as well as several hospital directors concur that 2014 was the year where the number of uninsured patients went up dramatically. This adds up if ones take into account that the aforementioned 2-year social safety net has by now lapsed. In the meantime, data collected by social clinics and pharmacies point to the fact that the health conditions they are dealing with are becoming more and more serious. Even patients with advanced cancer seek their help as they cannot afford their treatments anymore. This brings us to one of the cores of the access to medicines problem in Greece today: patients are increasingly becoming their own doctors, self-managing their condition and selecting treatments based on what they can afford and not what is right for them. This is the case not only for the uninsured but also for those who still enjoy some sort of social coverage; for example the pensioners with their considerably reduced income. This category includes all those affected by the significantly increased co-payment percentages and out of pocket expenditure. Moreover, social clinics are reporting numerous cases of both uninsured and insured patients whose health has worsened because of this treatment self-management. These policies contribute to worsening health conditions on one hand and on the other hand; higher cost for the public health system which will eventually be forced to deal with more serious health conditions.

But what happens to an uninsured person who gets sick or suffers from a chronic disease in Greece today? In June 2014, under growing pressure the government came up with a long overdue ministerial decision to guarantee that no uninsured will be left without health coverage. In essence, this decision puts the responsibility squarely on the public hospitals. It foresees the establishment of a hospital committee that will examine on a case by case basis whether a patient falls under the category of “uninsured” and can thus be hospitalized and benefit from all the services for free. It all sounds very good on paper but several state hospital directors already complain and emphasize that the reality on the ground is very different as: a) the procedure is heavily bureaucratic and time-consuming making it practically impossible for the uninsured to gain access to the treatments they need, b) red-tape always discourages adherence; not to mention c) every public hospital has a very specific budget and cannot bear the additional cost. It is therefore not surprising that patients choose to visit the hospitals’ emergency care units where treatment cannot be denied and is provided irrespective of one’s insurance status. A similar trend has been well documented in Spain.

According to the OECD, health spending in Greece has dropped in each of the years since 2009, driven by a sharp reduction in public spending as part of government-wide efforts to reduce the large budgetary deficit. In 2015, state pharmaceutical spending is capped at 2bn euro or 1% of the GDP (it stood at almost 6 bn in 2008).

The typical line of argumentation used by Greek government and Troika officials in responding to the access to medicines concerns is that there is no statistical data and most stories are based on anecdotal information. This has paved the way for them to embark on a denialism campaign claiming that the storm is abiding and the crisis fades away. Clearly, this is not true.

There are some short-term, medium-term and long-term options that the new government can implement so as to effectively address the access to medicines crisis the country faces. Firstly, it should strive for further price reductions with an emphasis on expensive life-saving treatments for chronic diseases such as cancer, Hepatitis C, HIV, diabetes and others. It is a common secret that the pharmaceutical industry is charging immoral prices for medicines that are not always innovative. Secondly, it will have to guarantee transparency and unconditional accountability on all levels of policy-making in the public health sector especially concerning pricing & reimbursement policies. To this end, it would be worthwhile to publish detailed information on state pharmaceutical expenditure (both in volume & value). Moreover, since the start of the crisis, there have been efforts to increase the use of generics in the country. These efforts will have to be strengthened as a healthy generics competition leads to affordable treatments for more patients. At the same time, public authorities ought to inform and reassure public opinion about the quality and safety of generics. Health policies particularly with regards to the pharmaceutical expenditure should be dictated by comprehensive impact-assessment studies along with health indicators taking into account the real needs of patients as well as the sustainability of the public health system. It is important to note that new medicines should be evaluated based on their real added therapeutic value. Once more; a maximum degree of public scrutiny needs to be ensured during the negotiations with the pharmaceutical industry. Patient engagement in decision-making bodies such as the national medicines organization (EOF) is another key parameter and common practice in many European states. The next government will have to reexamine the increases in the co-payment percentages that caused the damaging for patients treatment self-management. Keeping in mind that unemployment does not show any sign of being significantly lower in the near future, it is imperative that the Greek government shifts away from the current employment-dependent health coverage system towards a new national insurance scheme that will guarantee access to medicines and health services for everyone.

Additionally, the Greek government could explore the possibility of using the tools offered by international trade rules i.e. the TRIPS flexibilities and price controls such as compulsory licensing in order to enable the breaking of the license, asking other laboratories to develop the medicine and reduce its price by means of generics competition.

On the European level, the future Greek government should join forces with its European partners in questioning the current patent-based model of medical innovation (development of new drugs) and pricing which is the root cause of the problems most countries are faced with. Numerous public health systems cannot afford the exorbitant prices that pharmaceutical companies are demanding and patients are left without their medicines. It is a matter of political will and determination; the EU should allow for the development of alternative mechanisms to stimulate medical innovation such as patent pooling & equitable licensing, open data, collaborative data sharing and innovation prizes to name a few. This is a praiseworthy painstaking long-term objective and requires collective action at the EU Council level. Furthermore, more public investment is necessary as public budgets dedicated to health are rapidly declining across the Union. It is oxymoron that most medical research is publicly funded, yet the question to ask is what do we get in return? EU investment should be with strings attached in transparency, affordability and access.

Even if health does not fall under EU competence, there is ample space for governments to define the parameters of European research and innovation, rules of transparency, intellectual property rules enforcement and many other areas at an EU scale. Governments in Europe today find themselves in a far weaker place than pharmaceutical companies who benefit from the obscurity that prevails in the sector and is conducive to dealings under the counter. To this end, it is worthwhile examining the prospect of activating the joint procurement mechanism in order to maximize states’ negotiating capacity towards the pharmaceutical industries.

Last but not least, Greek patient groups and civil society have a key role to play. They should not be taken for granted as simple solidarity-support mechanisms that can substitute state health services. Should this volunteer movement develop into a parallel health system, this will be a major step backwards for the country. On the contrary, these much-needed organisations should invest in their advocacy capacity. They should aim to foster social dialogue among stakeholders (pharmacists, doctors, pharma industry) and shape policy-making while striving for the highest degree of transparency and public scrutiny in the Greek public life. To this end, it is essential that they prioritise as well as elaborate on concrete policy asks and recommendations. This way they can fulfill their potential and help the newly elected government move in the right direction.

Policy makers in Greece and in the EU need to show a lot more political will in facing the worsening access to health-care crisis. Let´s all hope that the worst in not yet to come.

Spanish Hepatitis C Patients Petition European Parliament

Petition to the European Parliament “For a European Plan for against Hepatitis C” presented by “Plataforma de Afectados por la Hepatitis C”(Spain)

 

 

Mario Cortes Morales, Spanish citizen, in representation of the “Plataforma de afectados por la Hepatitis C” (Platform of people affected by hepatitis C), presents this petition before the European Parliament.

 

Taking note of written declaration 87/2006 presented by MEPs Jolanta Dickute, John Bowis, Stephen Hughes, Frederique Ries and Thomas Ulmer concerning the need of the EU to combat Hepatitis C and to help provide treatment for those affected, which was approved by the majority of the European Parliament and was published in “Approved Texts” of the session 29.03.2007,

 

Considering that according to estimations over nine million citizens and residents in the EU are affected by hepatitis C and that every year there are thousands of deaths due to this illness,

 

Taking into account that the European Union does not have direct competences for the financing of public health nor the setting of medicine prices but considering that the EU does coordinate a voluntary system of EU member states that establishes reference prices for medicines and that other EU competences do affect drug prices of Hepatitis C treatments.

 

Considering that the European Union has legal competences over intellectual property policies, international trade, scientific research and innovation, the public debt of EU member states, the approval of new medicines, the internal market, clinical trial and price transparency, public procurement law and competition rules, among other norms that affect the price and access to Hepatitis C medicines,

 

And considering that access to health-care and the right to life are two fundamental rights defended by the European Union,

 

Requests the presentation of a European Plan against Hepatitis C that includes the coordination on the part of the European Commission of policies of joint procurement of affordable Hepatitis C treatments among EU member states.

 

Demands that the European Commission, the Council and the European Parliament present concrete policy proposals and flexible changes in EU legislation concerning intellectual property with the objective of encouraging the rapid entry into the european market, either from European production or importation, of affordable generic versions of the most effective and safe therapies for all EU citizens and residents affected by Hepatitis C.

 

Requests the creation of an EU emergency health-care rescue fund for people affected by Hepatitis C en EU member states affected by public spending austerity measures mandated by the EU and askes the European Commission to carry out a health impact evaluation of health-care cutbacks with special reference to their impact on Hepatitis C patients.

 

Asks the European Commission to carry out a study and to collect public-health data concerning the prevalence of Hepatitis C in the EU.

 

Requests the adoption of legal EU norms for the public transparency of the prices paid for medicines in the public procurement of medicines.

 

Demands that the European Commission opens up an investigation of the possible violation of EU competition law and public procurement law in the marketing and purchasing of high-priced new medicines for treatment of Hepatitis C.

 

Asks the European Commission to finance econometric studies on the possible future scenarios concerning the economic and health system viability of the erradication of Hepatitis C in the European Union.

 

Requests that the European Commission adopts a series of recommendations of best practices for EU member states and the European health-care community for the treatment and cure of Hepatitis C.

 

Asks the European Commission and the Council of Member States to propose a series of measures in the areas of research, financing and best practices to guarantee the early detection and diagnosis of Hepatitis C.

 

Requests that the Horizon 2020 programme includes an innovation inducement prize for the production of a single-dose treatment for Hepatitis C that could enter the EU market as a generic medicine at an affordable price for the large majority of European patients by means of a non-exclusive, socially responsible intellectual property license.

 

Asks that all research studies financed by the Horizon 2020 programme related to Hepatitis C be guided by the rules mandated by the pilot programmes for “open data”.

 

 

Bruselas, 21 de enero de 2015

 

 

Five poor excuses used to block EU Ratification Marrakesh Treaty

blind girl

 

The Marrakesh Treaty was agreed in June, 2013. Now we are well into 2015 and the EU still has no plan on how to ratify the Treaty. While many other countries have either ratified or, at least, made progress to that end, the EU Council is not moving at all toward ratification. This is in total contradiction of the EU´s legal obligations with the UN Convention on the Rights of Persons with Disabilities.

 

Here are a few of the poor excuses being used to stall, delay and block EU ratification.

 

  1. It is not EU competence”It clearly is. Both Commission and Council legal services say it is. Here are the legal arguments given by the European Commission in its request for ratification:

    Finally, Article 6 of Directive 2001/29/EC provides comprehensive legal protection for

technological measures used by right holders and Article 6(4) provides that Member States

must ensure that beneficiaries of certain exceptions or limitations benefit from those

exceptions where technological protection measures are in place, in the absence of voluntary

agreements. Articles 3, 4, 7, 10 and 11 of the Treaty affect these provisions of EU law.

As a result, it is considered that:

a) the cross-border exchange of accessible-format copies with third countries is a predominant

element of the Treaty, therefore its relevant articles fall under the common

commercial policy (Article 207 TFEU); and

b) the articles of the Treaty on mandatory exceptions or limitations fall within the scope of

EU law, affect or alter the scope of the common rules, namely those in Directive

2001/29/EC and in any event are within an area which is already largely covered by

EU rules (Article 114 TFEU)8.

The Commission is therefore submitting a proposal for a Council Decision on the conclusion

of the Treaty. In accordance with Article 218(6)(a)(v) of the TFEU, the European Parliament

has to give its consent before the Decision is adopted.”

  1. Mixed competence ratification can be just as quick as EU competence”This is totally false because until each and every EU member state ratifies(often through national parliaments), the EU cannot ratify and implement the Treaty. Until all ratify, none have ratified. This will probably take many years and maybe never be completed.
  2. We have to wait for the new EU Copyright Directive”This is not necessary because exceptions for disabilities is already foreseen in the current Information Society Directive. If, in the unlikely case, some small legal modifications in EU law are needed, this can be done fairly quickly by means of a narrow, pinpointed legislative procedure.
  3. We have to first have national laws ready for implementation”This is not how national implementation of EU law usually works. First, the EU approves its laws and afterwards the EU member states are given a time period for national “transposition” of the new legal framework.
  4. Allowing EU competence will be a dangerous precedent for other treaties”The Marrakesh Treaty is based on international human rights obligations and is a very special case that affects people with disabilities. It should not be mixed up with other political or economic questions that are of a very different nature.
  5. If it is EU competence it will only count as 1 ratification instead of 28”More than 20 countries (the number needed for the Treaty to go into effect) around the world have either ratified or have started the procedures for ratification. What is most important is that the large proportion of accessible-formatted books in the world that are in EU member states. These books need to be part of the cross-border exchange mechanisms of treaty to make it meaningful for visually impaired persons around the world.

 

 

 

High priced hepatitis C treatments spark massive public outcry and political debate in Spain

 _hepattis_e52822ec

 

 

In one of the the largest public health marches in Europe in decades thousands of hepatitis C patients and public health defenders marched through the streets of Madrid last Saturday to demand “treatments for all”. http://www.cuartopoder.es/invitados/2015/01/10/en-directo-marcha-moncloa-en-apoyo-de-los-afectados-por-la-hepatitis-c/4171 The protest was organized by La Plataforma de Afectados por la Hepatitis C (PLAFH) * and was supported by dozens of NGOs, trade-unions and by opposition political parties from the center and the left. Throughout the demonstration civil society and political representatives expressed harsh criticism of both the Spanish Government and the pharmaceutical industry. The cut-backs in the Government´s public health spending and the abusive prices of the industry were the main targets of the crowd´s chanting.

 

In Spain there are an estimated 700 thousand people infected by Hepatitis C while around one-third of them have been diagnosed. Approximately 50 thousand patients are in the advanced stages of the illness. Many of these patients cannot be safely treated with existing treatments due to complications and/or their genotype.

 

Sovaldi, the first of a new generation of more effective and safer Hepatitis C drugs was approved for purchase by the Spanish Government last summer with the promise of very high rates of curation, lower secondary effects and easier dosification. In most cases Sovaldi needs to be combined with at least one other medication. The Spanish authorities decided to earmark 125 million euros for the purchase of Sovaldi at a price of 25 thousand euros per three month treatment. This would mean the treatment of only approximately five thousand patients in 2015. Health authorities issued a very restrictive clinical protocol for rationing Sovaldi prescriptions only to patients in the most critical condition.

 

Patient associations rejected the official recommendations as unfair while Spanish hepatologists and other doctors around Spain labelled the rationing criteria as “unprofessional and anti-scientific”. http://www.diariomedico.com/2014/12/19/area-profesional/sanidad/hepatologos-critican-duramente-ministerio-hepatitis-c A week before Christmas Day dozens of Hepatitis C patients started a 24 hour sit-in at on the Madrid´s largest hospitals that has continued to date. The patients´ hospital protest and the whole support movement has attracted daily media coverage including top TV coverage over the past month.

 

At first the patient platform only criticized the Government for the cut-backs and demanded to increase drug purchases of Sovaldi up to 800 million euros. But soon the public debate and patient demands started to include the abusive prices of a pharmaceutical model based on patent monopolies. Due to widespread traditional and digital media coverage, the rage of Spanish public opinion ignited when it learned that the cost of producing Sovaldi was only around 100 euros and that Gilead was making fabulous profits thanks not to their own research but to a speculative buy-out of the patent. Citizens groups such as Salud por Derecho, No Gracias and the TransAtlantic Consumer Dialogue, among others, have helped stimulate this public discussion on the high price of many drugs, the IPR system and the possible solutions. http://blogs.elpais.com/3500-millones/2014/07/los-enfermos-de-hepatitis-estan-por-encima-de-las-patentes.html

 

A few weeks ago the spokeperson of the Hepatitis C patients platform, Mario Cortés, started to also criticize the pharmaceutical company Gilead and to demand a compulsory license as permitted by the WTO´s Doha Agreement to produce Sovaldi as a generic. http://es.euronews.com/teletipos/2867244-los-enfermos-piden-800-millones-al-gobierno-para-tratar-la-hepatitis-c/ He also began to include in his high-profile public statements the high cost of many cancer drug and other treatments that are being rationed in Spain. The centrist party Unión Progreso y Democracia was the first political group to suggest the use of the flexibilities in international law to produce a generic version of Sovaldi. A week ago the new rising star in the Spanish political scene, Podemos, demanded that the Government “expropriate” the patent and produce an affordable treatment. The left party Izquierda Unida even demanded in the Spanish Parliament an official challenge to the patent monopoly over Gilead through the issuing of a compulsory license. The Socialist Party has not questioned the patent but, instead has requested 200 million euros more in the budget. The opposition parties also contrast the billions in public money spent on bailing out Spanish Banks with the inability of the State providing the best treatment for the ill. Hepatitis treatment has become a hot political issue in Spain today.

 

The Government has named a Commission of national and international experts to write a strategic plan to combat Hepatitis C. It is headed by a long-time advisor of the pharmaceutical industry who has already advanced that patients with the “early stages of fibrosis” would not be eligible for treatment with the new drugs and “would have to wait”.

 

A few months ago the European Parliament plenary session debated the issue of the high price of life-saving medicines, specially Hepatitis C ( http://tacd-ip.org/archives/1211 ). In response to written questions the European Commission has insisted that medicine prices are a national competence as well as the decision on emission of compulsory licenses to bring out a generic product in case of a public health need. . The Commission added that it would have to review the health justification of reverting to a compulsory license to produce a Generic. While EU member states are party to the Doha Declaration on public health flexibilities of intellectual property rights which allow compulsory licensing, they are forbidden from importing generic versions from outside the EU of drugs that are under patent in the EU. A French initiative to drive down prices by means of joint public procurement of many EU States has not prospered due to the lack of price transparency and weak political will. At the same time a European plan for differentiated pricing (tiered pricing) among EU states is being supported by the pharmaceutical industry and some patient groups (In fact, prices already differ between EU countries). In general, the European Commission is not showing leadership on this issue and it has continued to be a steadfast defender of rigid EU IPR rules on pharmaceuticals both within EU legislation and in trade negotiations underway, such as those for the transAtlantic TTIP agreement with the US.

 

In Spain, the fight for affordable treatment of Hepatitis C will probably become a campaign issue in the regional and national elections that will take place in May and November, respectively.

 

An expensive, market-oriented pharmaceutical model that has clearly failed to provide access to life-saving medicines for the majority of the population of the Global South is now also not working for millions of European citizens. One might say that “the chickens have come home to roost” as we are now facing the dire consequences of our very own flawed model of biomedical innovation and marketing.

 

 

 

 

* PLAFH is a platform of the following organizations:  Federación Nacional ALCER (Federación Nacional de Asociaciones para la Lucha Contra las Enfermedades del Riñón), Confederación Española de Asociaciones de Familiares de Personas con Alzheimer y otras Demencias (CEAFA), Esclerosis Múltiple España (EME), Liga Reumatológica Española (LIRE), Federación Española de Cáncer de Mama (FECMA), Federación Española de Enfermedades Raras (FEDER), Federación Española de Parkinson (FEP), Federación Española de Asociaciones de Anticoagulados (FEASAN), Confederación de Asociaciones enfermos de Crohn y colitis ulcerosa de España (ACCU), Federación Española de Fibrosis Quística (FEFQ), Federación Nacional de Asociaciones de Prematuros (FNAP), Federación Española de Enfermedades Neuromusculares (Federación ASEM), CONARTRITIS (Coordinadora Nacional de Artritis), Federación Española deTrasplantados de Corazón (FETCO), Asociación de Ayuda Afasia Fundación Hipercolesterolemia Familiar AECOS (Asociación Española contra la Osteoporosis), FNETH (Federación Nacional de Enfermos y Trasplantados Hepáticos), y Asociación Española de la Enfermedad de Beçhed, Asociación Española de Pacientes con Cefalea.

Marrakesh Ratification: Written question by 19 MEPs to the Council of the European Union

On October 21th 2014, the European Commission proposed the ratification, on behalf of the EU, of the Marrakesh Treaty to Facilitate Access to Published Works for Persons who are Blind, Visually Impaired, or otherwise Print Disabled.

The ratification by 20 countries is necessary for the Marrakesh Treaty to enter into force. Only 1 to 5% of published books are available in an accessible format for visually impaired persons worldwide. The ratification of the Marrakesh Treaty by the EU will help address this “book famine” that deprives 250 million people of access to culture and education.

The EU, authorised by the Council, signed the Marrakesh Treaty on 30 April 2014. The Lisbon Treaty grants the competence of ratifying international agreement to the EU (Art 218), the European Court of Justice has confirmed this EU competence in relevant cases. It is now for the Council to authorise the ratification of the Marrakesh Treaty by exclusive EU competence.

If Member States refuse, or propose shared competence, the ratification will be significantly delayed, and so will be the application of the Treaty. If this is the case, on what legal grounds would the Council base its objection to the ratification of the Marrakesh Treaty under exclusive EU competence?

Juan Carlos Girauta Vidal, ALDE

Javier Nart, ALDE
·         Fernando Maura Barandarian, ALDE
·         Yana Toom, ALDE
·         Enrique Calvet Chambon, ALDE
·         Mircea Diaconu, ALDE
·         Jean-Marie Cavada, ALDE
·         Marielle De Sarnez, ALDE
·         Enrico Gasbarra, S&D
·         Alessandra Moretti, S&D
·         Giorgos Grammatikakis, S&D
·         Julia Reda, Green
·         Pascal Durand, Green
·         Marie Christine Vergiat, GUE
·         Marc Joulaud, EPP
·         Bogdan Wenta, EPP
·         Rosa Estaras Ferragut, EPP
·         Santiago Fisas Ayxela, EPP
·         Pilar del Castillo EPP

Scary Broacasting Treaty: short oral statement at WIPO

copyright

Thank you very much.The TransAtlantic Consumer Dialogue is concerned about the discussion on this treaty. Whereas in the past, due to the lack of definitions, we called it an unidentified flying object, now, as the definitions get a bit clearer, we feel it’s becoming a more identified flying object in the air as a transmission and, precisely because it’s becoming identified, some of these definitions we consider are very concerning for us and we are worried about these definitions because we think these definitions and these protections of rights could mean a threat to access to culture, a threat even to freedom of speech, and a threat to the public domain. Let´s remember that we are talking about a public domain, about public broadcasting signals.
We think these threats are coming from a scope that is much broader than is recommendable. It is a scope that could contradict a lot of the digital rights that millions of young people around the world are fighting for and defending. And I think this sensitivity of digital rights of mixing, of the type of things that go on every day millions of times on the Internet should not be threatened by this treaty. So how can we avoid that? We could avoid that by avoiding any post fixation rights.
We could also avoid it by a very narrow definition of simultaneous or near simultaneous traditional broadcasting signals to the public in the air. Broadcasting should mean, similar to the Rome Convention, the transmission by wireless over the air by means for public reception of sounds, of images and of words.
As well, what is a signal? What is a signal? A signal obviously could not just mean everything. A signal means an electronically generated traditional carrier over the air with sounds and images. What we really need is to narrow down the scope to a point where we don’t see this as something that can be a threat to the creativity, innovation, new business models at a time when we know that the business models need that flexibility, what we don’t need is yet another layer of bureaucratic costly rights that would be burdensome for the future of the Internet.
For these reason, for consumers, for Internet users, for culture, for new innovation, we would like to call for this very narrow definition of the scope. Thank you very much.

Blind persons push for EU Marrakesh Treaty ratification: frustration as EU member states block process

 At an event yesterday at the European Parliament blind persons organizations expressed their frustration at the lack of progress toward EU ratification of the global right-to-read Treaty of Marrakesh.

 

The meeting was organized by the European Blind Union, the World Blind Union, Knowledge Ecology International-Europe and the Transatantic Consumer Dialogue under the sponsorship of MEPs Enrique Calvet (ALDE, Spain), Alessandra Morretti (S and D, Italy) and Max Andersson (Greens, Sweden). Other MEPs attending the meeting were Julia Reda (Greens-Germany), Patrick Durand (Greens-France) and Fernando Maura (ALDE-Spain).

Key leaders of European visually impaired persons were present such as the Italian secretary of the European Disability Forum, Rodolfo Cattani,  Bernadette Otto of the Belgian Blind Persons Associations and Mokrane Boussaid, the executive director of the European Blind Union.

 

The respondent on the part of the European Commission was the head of the Copyright Unit Maria Martín Prat. Also participating in the meeting was Inmaculada Placencia, Deputy Head of the Disability Unit of DG Justice. As well, the incoming Latvian Presidency of the EU Council was present.

 

MEP Enrique Calvet opened the event by asserting the importance of defending the dignity of persons with disabilities and stating the priority of the European dimension of the ratification of the Marrakesh Treaty above the nationalist demands of member states. The Royal National Institute for the Blind representative Dan Pescod explained how copyright acts as a barrier to exacerbate the book famine suffered by the visually impaired and stressed how the Marrakesh Treaty would allow the cross-border flow of books to millions of persons globally who lack access to cultural and educational materials. Wolfgang Angermann said that blind persons were about to lose their patience with an endless ratification process and that human rights should take precedence over quarrels on EU procedures and competence. Francisco Calvo from the Organización Nacional de Ciegos de España said that the Treaty was an important move toward creating an open single market in the EU for accessible formatted works.

 

Maria Martín Prat stated that the European Commission had a firm commitment for the swift ratification of the Treaty and has requested that the Council approves the ratification under exclusive EU competence. Nevertheless, according to Prat, many EU member states are very reluctant to concede the EU the power to sign the Treaty in name of the member states. She explained that at the last meeting of the Council on November 24th EU exclusive competence over the treaty was not accepted by most of the member states and many of them prefer ratification through “mixed” or “shared” competence. This would mean a long, torturous procedure in which all 28 separate national ratifications will be needed before the EU (national ratifications would not be valid until all the EU has ratified). In the words of Dan Pescod we shall have EU ratification “only when the slowest camel of the caravan crosses the line”. In this case it would at best be many years before we see the Treaty go into effect with the greater danger that even one EU member state could block the whole process.

 

A number of MEPs present have decided to take parliamentary initiatives, such as written and oral questions with a possible plenary resolution, in order to place pressure on the Council and member states to speed up the ratification process. A number of blind persons organizations will also promote parliamentary questions in national parliaments and meetings with relevant national ministries before the next meeting of the EU Council working group on this issue on January 29th, 2015.

 

Film Screening: “The Internet´s own boy”

TACD is pleased to invite you to a film screening of “The Internet’s Own Boy: The Story of Aaron Swartz” on 1 December 2014 at 6:30 pm in the European Parliament.

Aaron Swartz represented the best and the brightest of a generation of young people who have grown up with the Internet. He was a brilliant programmer, writer and political activist who died tragically at a very young age. His legacy is specially relevant as we are considering new EU copyright legislation. Access to academic data, democratic control over information and freedom of speech were at the centre of his struggle. He sought change and was willing to disobey unjust laws to bring that change about. As you shall see in this documentary Aaron was very clear about his positions:

“Information is power but like all power, there are those who want to keep it for themselves. The world’s entire scientific and cultural heritage, published over centuries in books and journals, is increasingly being digitized and locked up by a handful of private corporations. There are those struggling to change this. The open access movement has fought valiantly to ensure that scientists do not sign their copyrights away but instead ensure their work is published on the Internet, under terms that allow anyone to access it.”

“There is no justice in following unjust laws. It’s time to come into the light and, in the grand tradition of civil disobedience, declare our opposition to this private theft of public culture. We need to take information, wherever it is stored, make our copies and share them with the world. We need to take stuff that’s out of copyright and add it to the archive. We need to buy secret databases and put them on the Web. We need to download scientific journals and upload them to file sharing networks. We need to fight for Guerilla Open Access.”

“With enough of us, around the world, we’ll not just send a strong message opposing the privatization of knowledge — we’ll make it a thing of the past. Will you join us?”

Should you require a badge for the European Parliament, please RSVP to dimi@wikimedia.be stating your full name, identity card/passport number, date of birth and nationality.

Details

Start:
December 1, 2014 6:30 pm
End:
December 1, 2014 8:30 pm

Venue

European Parliament
60 Rue Wiertz, Room ASP 3G2 Brussels, Belgium

+ Google Map

EU: RATIFY THE MARRAKESH TREATY! event on December 2nd

Ratify the Marrakesh Treaty
for the right to read of blind and other visually impaired persons

Sponsoring MEPs: Alessandra MORETTI (S&D, IT), Enrique CALVET CHAMBOM (ALDE, ES), Max ANDERSSON (Greens/EFA, SE)
Co-organisers:
Trans-Atlantic Consumer Dialogue (TACD)
European Blind Union (EBU)
World Blind Union (WBU)
Knowledge Ecology International (KEI) Europe
Date of event: 2 December 2014, 10:00-12:00
Location: European Parliament, room ASP A5G-1, Brussels

On June 28th, 2013 the Marrakesh Treaty to Facilitate Access to Published Works by Visually Impaired Persons and Persons with Print Disabilities was concluded in Morocco.

This international binding UN/WIPO treaty aims at ending the “book famine” that deprives 250 million people of access to culture and education. Visually impaired persons only have access to between 1 and 5% of the books published. The agreement focuses on copyright exceptions to facilitate the creation of accessible and affordable versions of books and other copyrighted works. It sets a norm for countries ratifying the Treaty to have a domestic copyright exception covering these activities, and allowing for the import and export of such material.

Objectives
The EU finally signed the Treaty in April 2014 and in October, 2014 the European Commission formally asked for authorization from the Council and the European Parliament to ratify the Treaty. Nevertheless, among a number of EU member states there is resistance against accepting EU competence over the ratification of the treaty despite the fact that both Commission and Council legal service opinions assert exclusive EU competence over this issue. If authorization of EU ratification is not accepted by EU member states, it will take many years before the Treaty is ratified and implemented.

Blind people, MEPs, the European Commission and other stakeholders will discuss the meaning of this landmark treaty for human rights and will urge swift ratification and implementation by the EU and its member states.

Programme
Welcoming remarks by Enrique CALVET CHAMBOM (ALDE, ES)
Why the EU should ratify the Marrakesh Treaty now and how to make it happen
Francisco Javier Martínez Calvo, Organización Nacional de Ciegos de España (ONCE)
Wolfgang Angermann, President, European Blind Union
Dan Pescod, International Campaigns Manager, Royal National Institute of the Blind, UK
Maria Martin-Prat, Head of Copyright Unit, European Commission

Closing remarks by Alessandra MORETTI (S&D, IT) & Max ANDERSSON (Greens/EFA, SE), JURI rapporteur on the Marrakesh Treaty
Should you require a badge for the EP, please RSVP to  HYPERLINK “mailto:ratify.tvinow@gmail.com” ratify.tvinow@gmail.com
stating your full name, identity card/passport number, date of birth and nationality.

“Can we afford our medicines?” Complete summary with document links

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

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

Welcoming remarks by Kostas CHRYSOGONOS (GUE/NGL, EL)

Affordable access to medicines: the situation on the ground

Introduction by Beatriz BECERRA BASTERRECHEA (ALDE, ES) @beatrizbecerrab

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

  • François Berdougo @FBerdougo, Secretary General of the Harm Reduction Working Group of 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?

Introduction by Michèle RIVASI (Greens/EFA, FR) @MicheleRivasi

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

  • Jamie Love @jamie_love, Director, Knowledge Ecology International (KEI) & U.S. Chair of the Intellectual Property Committee, TACD 
  • Teresa Alves, International Policy Adviser, La Revue Prescrire,
  • Prof. dr. Graham Dukes, University of Oslo

Q&A session

The European Commission was represented by DG SANCO & DG Enterprise

Concluding remarks by Nessa CHILDERS (S&D, IE) @nchildersMEP

You can see & download speakers’ slide presentations at http://tacd-ip.org/archives/1238. The webstream of the whole event is here: http://greenmediabox.eu/en/ct/62-Can-we-afford-our-medicines- & at http://82.197.155.96/gmbox/39/src/20141112_medicines_or.mp4. Join the discussion on twitter using #a2mEurope. For any questions, email a2m.Europe@gmail.com.  Please see end of this report for additional sources of useful information.

Detailed summary

Kostas Chrysogonos (GUE/NGL, EL) welcomed everyone and explained that this event is necessary because the lack of access to medicines is a reality in many EU Member States today. Health services need to be reformed, he agreed, but not in a violent and irrational way. He continued by giving the example of the Greek situation with a number of citizens’ not receiving social security or access to healthcare, although they had paid their contribution to the social system for many years. It is not about excluded people or migrants, but people who used to work and are now unemployed. This is the case for many families in Greece which cannot be provided vaccination or access to treatments. The horizontal budget cuts excluded a big part of the population from health services, he explained, but this was also the case for other countries. There are cuts in the health service sector, and in the meantime, funds and resources are reduced drastically. Health products are no longer available as public goods but commercial products. Medical innovation is currently based on patent monopolies; a system no longer working. There were dis-functionalities before the crisis, administrative burden and reforms are necessary, he agreed, but the way they are doing them is wrong. This is all about cuts in spending. The reform should be the result of a social dialogue, not imposed by politicians, especially in countries under Troika supervision and not imposed by external actors. The subsidiarity principle should be taken into account. The needs of society and for adequate systems should correspond to modern needs without excluding citizens. He hoped that this meeting would allow for the undertaking of effective action.

Beatriz Becerra Basterrechea (ALDE, ES) began by explaining that she was a new MEP and did not know many things about medicines or research. She was not a doctor or a scientist, but she thought she was good with diagnosis. Health is not a luxury but a basic right, she stated. The question is about how to guarantee that right. Public funding must serve public interest. The crisis and imposed measures on budgets had dramatic consequences on access to medicines and should be the starting point for the rethinking of new models of public health pricing and medical innovation. It is not acceptable that millions of EU citizens are not receiving the highest quality life-saving medicines because governments cannot pay for the skyrocketing costs for the best treatments. The current model of medical innovation and pricing does not work. It has failed to promote real innovation and has become far too expensive for most of the world including many Member States, mentioning the case of hepatitis C treatments. The patent monopolies model was supposed to be an incentive for generating innovation but has turned out to be an obstacle. Its objective, of producing affordable useful products needed by societies, has failed. Public investment means 85 per cent of medical research must result in 85 per cent public return for public health instead of the privatization of knowledge by means of patent monopolies, she explained. Health innovation should develop products and services that are affordable and accessible. There is no doubt of the right of companies to have a profit, but life and death is a general interest issue and not just a business. New models are needed to break monopolies and push medicines towards real health needs and not just blockbuster profits.

Panel 1: Affordable access to medicines: the situation on the ground

David Hammerstein, senior policy advocate, TACD, introduced the panel and listed some of the keywords which might underpin this first session. Most notably, he drew attention to transparency, transparency of prices and transparency of clinical trials. How many times do we have to pay is also a question. Are public investment protected to give back public returnin form of public health and access to medicines? Another keyword is efficiency, with the question, are systems efficient, could they be more efficient by sharing knowledge, by sharing results and data? Hammerstein then raised the issue of unethical practices, competition issues touching upon the entry of generic onto the market and the relationship between doctors and pharmaceutical companies.

The monopoly issue is often linked to not fueling innovation but preventing it, he said. Monopoly is not a good word in this house, he added, and they have to be broken up. However, this has not been considered about the pharmaceutical sector in his opinion. Some people think there is a monopoly position in the production of R&D, with the marketing and selling of the products.

Hammerstein disagreed the EU lacked competence, and suggested it was about EU measures of fiscal austerity, of transparency, IPR policies, EU innovation and research policy and investment, non-discrimination and basic fundamental rights. No studies have been done on the health impact of the Greek budget cut measures, despite massive cuts. No provisions exist of how we are going to pay the price of best treatments for many medicines. There is no sharing of knowledge of Health Technology Assessments, he continued. No price caps are considered as the example of roaming in the EU. Solutions will come from civil society, experts and politicians, he added. Access to medicines and healthcare is the best policy. If it does not work for all, it is not working at all, he concluded.

François Berdougo, Secretary General of the Harm Reduction Working Group of Médecins du Monde began his presentation by giving a few highlights on the work of Médecins du Monde. Médecins du Monde documented the negative consequences of healthcare budget cuts in Greece on healthcare system and universal access to care. This includes an increase in users’ charges and the loss of healthcare coverage for approximately three million people. Médecins du Monde action worldwide focuses on programmes for drug users and their low access to life saving drugs. They defend the rights of drug users to access harm reduction services and show how the policies are feasible through programmes in different regions. Moreover, even in high income countries access to HCV treatments for injecting drug users remains low. Berdougo then went on to speak about the high level prices of HCV medicines, focusing on the example of Sofosbuvir. He explained that Sofosbuvir has strong therapeutic value and causes low side effects. However, in order to achieve universal access, affordable drugs are needed. Prices levels accepted in the US or considered in France are unbearable for many healthcare systems in a period of budget cuts. These price levels have consequences on access to drugs, he continued, leading to treatment rationing. He further illustrated his comments by comparing the necessary budget to treat all HCV patients with fibrosis stage F2 and above, being higher than the 2014 annual budget of Paris public hospitals. That situation has led to restricted recommendations of use by the High Authority for Health, because of the financial burden the French State would have to face, Berdougo said. In order to respond to risks of treatment rationing, Médecins du Monde built a coalition made of patient organisations, medical NGOs and found allies in healthcare professionals, economists and researchers. This coalition had been heard by the pricing commission, for the first time. It was the first time ever that civil society has been heard by this official state body. He reiterated that one of the key demands is for the French state to issue a compulsory-license for Sofosbuvir. Today, a debate exists in France on the issue of pricing criteria, new models of pharmaceutical innovation and research funding as a result, he said. He continued by mentioning the lessons learnt from the HIV issue and underlined that when there is competition from generics, prices can be driven down. He also noted the possibilities for governments to use the flexibilities offered by the TRIPS agreement, notably with regard to compulsory licenses or patent opposition. Compulsory licensing has been used by high income countries, he noted. He urged the institutions to push for a compulsory license, and if pricing negotiations between Gilead and the French government were to fail, for the government to use TRIPS flexibilities to achieve public health outcomes. They now promote a change of the legislation related to drug evaluation and pricing. He concluded by explaining that they will continue to promote a debate on medical innovation models driven by health needs and will try to put this issue higher up on the agenda. He stressed that implementing a compulsory license should be an option and not a dream.

Gonzalo Fanjul, Policy Director, IS Global Barcelona Institute for Global Health made a presentation on the impact of austerity policies on health and access to medicines. He began by mentioning a UNICEF campaign launched a couple of weeks ago on the impact of the crisis on children in the period 2008-2012 showing an increase in child poverty and capacity of families to cope with unexpected expenses. Fanjul explained the effect on mental health, nutrition patterns and lifestyle. Austerity seemed to be at the core of the problem, although it was not the only reason. He continued by explaining the two phases of fiscal response to the crisis. 2007-2009 showed an increase in social spending which reversed for the period 2010-2012 with the introduction of austerity. The impact has been extensive, diverse and likely to have long lasting effect on the right to health of EU citizens, he remarked. Health services were eroded with diverse intensity. It is still too early to speak about the broader consequences due to the lack of data, but Fanjul explained that they can already observe a huge increase of mental health disorders, as well as HIV and malaria outbreaks in Greece while waiting lists are expanding in many countries. There is also an increase in out of pocket expenses and restriction of coverage. Vulnerability appears to be a more difficult indicator to capture, however, indicators of fear of vulnerability have risen by 300 per cent in Spain due to the disappearance or weakening of traditional safety nets. Lessons learnt from the previous crises were of an increase of drug and alcohol abuse problems, psychological problems and long term effects of unhealthy behaviours in unemployed families. Coming back to the Spanish example, he raised the issue of nutrition patterns of children in school and malnutrition which were happening in critical periods of child development. The future impact on health capacity and productivity of the economy were easy to expect, he added. All of these factors raised the questions on how they were dealing with the crisis and the extent of how countries were following austerity policies. He then followed up on possible alternative reactions, comparing Greece and Spain with the Icelandic case. He further mentioned the possibilities raised by the WHO in times of austerity on health priorities and protection and vulnerability of groups, and on the debate with regard to efficiency and equity. Who is to be blamed, Germany, the Troika? Presenting a graph on the drivers of increasing inequality, he noted that the market was one of them, while transfers and taxes had also contributed to inequalities during the crisis.

Hammerstein suggested when people said that banks were too big to fail; he thought instead the emphasis should be that there are people who are too weak to fail.

Rohit Malpani, Director, Access Campaign, Médecins Sans Frontières (MSF) started with a presentation of MSF action worldwide and the access campaign launched in 2009. They observed that medicines are often unaffordable, not suited for conditions on the ground, or do not exist because the innovation system is not working in providing incentives. Lessons from the access campaign are that generic competition is a successful way to improve access to medicines, having led to a decrease of the cost of HIV medicines for example. Evidences are here showing that only generic competition leads to price reduction. This is also relevant for western countries, he added. The absence of generic competition shows unaffordable prices. The situation with new HIV/AIDS medicines which are under patent and monopolies make treatment unavailable for MSF and similiar organizations. There are therefore concerns about the economic sustainability of treatments, he continued, and not only concerning HIV/AIDS but for hepatitis C and other diseases.

The solution MSF promotes is the need for government to take action through TRIPS provisions. MSF is working in advocating for the use of these flexibilities. But EU countries and pharmaceutical companies are challenging the use of these safeguards and flexibilities in trade agreements. What the EU is pushing for instead is tiered pricing which, simply put, is offering different prices based on the perceived ability to pay of states. This is not a good strategy, he continued, as it allows charging whatever price companies wish. There are many problems: Industry is allowed to make decision about who pays what price, based on arbitrary criteria, such as GNI, not taking into account internal social differences. There is no sensitivity to economic and social factors and many patients are still left behind. Other concerns touch upon the lack of transparency of the prices paid in different jurisdictions. Therefore, governments cannot negotiate prices in an informed way. There is also no information, no transparency on research and development costs, he explained. Tiered pricing is arbitrary and irrational, he continued, and as well you often see countries paying different prices although ranking with the same GNI per capita.

The challenges today are what can be done to make changes. One way in the EU is the use of TRIPS flexibilities and price controls or to take other measures to increase transparency. They have to consider more deep changes to the current system not only looking at marginal changes but systemic changes.

Today’s innovation is based on patent monopolies. The cost of R&D is not linked to the price of the medicines, he said. Contesting the myth of the cost of R&D of medicines, he further referred to a statement made by GSK CEO on the cost of medicine development, being more about hundred million dollars than billions. MSF pleaded for developing a system that not only allowed for the development of affordable medicines but medicines that were needed. The crisis today is not only of access, he insisted, but of innovation. This is a challenge for the EU, giving the example of tuberculosis, antibiotics and Ebola. MSF asks for a system not driven by profit but health needs, new ways of creating incentives which delinks R&D costs from the end price. This could be through new models of R&D:

  • Innovation prizes

  • Patent pooling & equitable licensing

  • Open data

  • Collaborative data sharing.

MSF has developed a neglected diseases initiative pushing for the development of treatments for these diseases, making sure they are affordable. R&D has a cost, he agreed, and requires investment and risk. But the current system is not working for patients in the EU nor for the ones MSF is treating around the world. They hoped from today’s discussion to look at new models going beyond the patent system.

Hammerstein thanked MSF and said they were probably the ones that knew the situation on the ground the best. How can we ensure pharmaceutical R&D and social systems were health driven and not market driven, he asked.

Margrete Auken (Greens/EFA, DK) was shadow rapporteur on the clinical trials regulation and was calling for full transparency, she explained, with regard to the results and data of the trials once the marketing authorisation had been granted. There has been a big battle with the pharmaceutical industry over this. She also criticised the cost arguments. They have to be stronger and get rid of conflicts of interest of those prescribing medicines. Referring to Denmark, she said that the authorities do not call for a ban on conflict of interest but only declarations. They must be clearer that good administration means no conflict of interest.

Hara Georgiadou, Bridging Europe asked whether the 300 billion euros promised by President Juncker gave a place to health.

Marianella Kloka, Advocacy officer, Greek NGO PRAKSIS made a remark on transparency. They were at the beginning of the year invited by the WHO and the Greek ministry of health to contribute to the elaboration of health indicators to assess the outcomes of austerity measures and policy on health issues. They had no other communication since then even if promised with the results. Nevertheless, they have themselves started to monitor the situation, and have conducted research on beneficiaries of medicines for hepatitis C and vulnerable populations. Results show that visits to the doctor (for hepatitis C positive patients) decreased to 85 per cent from 2009 and onward, access to medicines (not innovative) was reduced to 65 per cent. They are talking about new innovative medicines today and they all want them, but she underscored what was happening with the current medicines.

Nikolas Tsemperlidis, representative from a Greek union of consumers raised the issue that access to medicines was connected to many parameters. This has to be connected to the social security systems, to income, competitiveness and entrepreneurship and people who serve medical societies. The representative then questioned the funding scheme of the European Medicines Agency, where 80 per cent is coming from the pharmaceutical industry while the US FDA model finds only 20 per cent. He pleaded for more in terms of transparency about what expert, what company, what financial interests, who is consulted. Moreover, approval should not only mention a majority in favour but declare who voted against. Finally, when it comes to temporary approvals, he asked, how are they given, whether there are limits. He concluded that the results of publicly-funded research should be available to the public for the common good.

Panayiotis Kouroumplis (Greek MP, leading opposition centre-left party SYRIZA) said that interests are important and influence decisions. The responsibility of civil society is important. If we decide to give up our rights to other people we will get the consequences. All today’s issues have to do with human dignity and access to medicines, he said. Nobody, without exception should depend on money to get access and stay alive. We need to find ways in order to react, and ways to develop another kind of thinking for all the people concerned by the issue, he concluded. He called for governments to consider issuing compulsory licenses.

Dr Eleni Alevritou, President, Greek Consumers Association EKPIZO said that her organisation is not exclusively dealing with medicines. Because of the situation in Greece they have decided to look at this area. She felt rather optimistic because of the presence of experts from different groups of the Parliament. The Parliament can today see excellent examples of the work of NGOs, she added.

Fanjul explained that in Spain as the result of fiscal constraint, they introduced prescription by active ingredients. This has been one of the main drivers of bringing down the pharmaceutical cost of the government back to the 2002 levels. What this means is that they should force the why not principle. In other words, when it comes to the issue of the use of compulsory licenses, governments should have to respond “why not?” at first and not “why?” If there are policy alternatives in these areas, why are they not implemented? That is what civil society should demand from governments.

Berdougo responded on transparency and conflict of interest. MDM made progress in France in highlighting conflicts of interests between patient groups & pharmaceutical companies, but at the moment they have to progress on transparency of financial relationship between health professionals and the pharmaceutical industry. They have to educate a lot of stakeholders about the R&D issue. A lot of physicians, politicians do not know about alternative models of R&D and research funding. This is important that politicians have these kinds of ideas as 10 per cent of MPs in France are actually health professionals. Nevertheless, they are brainwashed by pharma rhetoric. We have to change that, he concluded.

Malpani said that a lot of research is currently funded by public funds. Why are we not demanding more public investment? EU investment should be with a stringsattached in transparency, affordability and access. An important question is about what we are getting in return. A lot of public investment is made by Member States, and one of the most promising vaccines on Ebola was a decade ago handed over to the private sector. A substantial amount of money has been put into accelerating the development of three vaccines. What are we getting for the investment?, he asked. In terms of access on hepatitis C: new medicines can be affordable. The cost of producing them could be less than 200 dollars (as opposed to current 55.000$ price tag) with enough economies of scales in market places. We could be 18 months away from getting low cost hepatitis medicines on the market. “Why not?” he asked.

Panel 2: What can we do about the high cost of medicines?

Ellen’t Hoen moderator, Medicines Law and Policy said that she would like this panel to focus on solutions. She then invited Michele Rivasi (Greens/EFA, FR) to give an introduction.

Michele Rivasi (Greens/EFA, FR) explained the reasons why she was interested in the issue. As a biologist, her first approach to medicines issues came with the H1N1 pandemic when she criticised the alarmist decisions made by the WHO, as well as the conflicts of interest within the WHO and Member States pushing for the purchase of vaccines. At the time, there were differences of prices among countries and the result was that there had not been more death in countries having bought and used the vaccines than in others. She was also shadow rapporteur on the pharmacovigilance proposals, where the role of the EMA was looked at, and today thanks to the work of the European Parliament, experts’ declaration of interest has to be given. She further explained that she commissioned a study comparing prices of medicines in the EU, and the first results were that you find huge differences between countries (Italy, UK, France) due to different price strategy.

Rivasi then went on to speak about innovation, mentioning the case of Sofosbuvir and explaining that there is not so much innovation coming from big pharmaceutical companies nowadays, but that companies prefer buying innovative SMEs, increasing prices as each EU Member States is responsible for the price of medicines. This is very important because today it is about Sofosbuvir but there are also similar problems with breast cancer and hormonal cancer medicines. The problem can be seen in Greece where people cannot afford their medicines anymore. Tools are available, she explained and there must be an alternative to the patent system and exclusivity. She finally recalled that she posed the question in plenary and was answered that prices are a Member State’s competence. But each Member State has the possibility to make use of compulsory licensing and to open the license, asking other laboratories to develop the medicine and reduce its price. She is not against pharmaceutical laboratories, she explained, but there is an issue between public and private research. 1.8 billion euro is given by the EU to the Innovative Medicines Initiative (IMI) but without conditionality, she said. Public interest should come first, and she pleaded against the renationalisation of health. We have to act together to move forward, she concluded.

Jamie Love, Director, Executive Director, Knowledge Ecology International (KEI) & U.S. Chair of the Intellectual Property Committee, TACD made a presentation on implementing delinkage. He first agreed with previous speakers on the use of compulsory licenses. His presentation first explained the three main sources of funding for biomedical R&D, namely 1) grants from governments and charities; 2) profits from selling products protected by legal monopolies, the patent system is the most famous among them and 3) the drug tax credit offered by the US for the execution of clinical trials. Love continued by presenting figures (please consult respective slides) on the R&D investment from the private sector in comparison to global sales between 2004 and 2010, and illustrated his point with the case of cancer treatment R&D spending in Europe in 2009. After showing a graph on the relative spending on drugs and relative mortality rates for all cancers, showing a differential access and outcomes between countries with higher and lower income, he came with the idea of eliminating monopolies on cancer drugs and fund R&D with a combination of grants and three types of innovation prizes: End product prizes; Open source dividend; Milestone prizes. Furthermore, he developed on the EU example of an EU wide Cancer innovation fund and a plurilateral cancer innovation fund. He concluded on the role of Europe as supplier of innovation under the delinkage model, explaining that a greater reliance upon grants would first enhance the role of universities and SMEs in supplying innovation. Second the de-emphasis of marketing monopoly would create more competitive opportunities for SMEs in manufacturing and distributing. Last, new inventions can be patented, and patents can be fully exploited in foreign countries.

Teresa Alves, International Policy Adviser, La Revue Prescrire gave a presentation on “Stopping the spiral of exorbitant prices”. She began by introducing the publication Prescrire produced by medical professionals and financed from subscription only. They are a member of the international society of drugs bulletins and conduct drug reviews, looking at products and attributing ratings. More specifically, they assess, whether innovative medicines bring an advantage, harms reactions, efficacy and convenience for patients. They also make comparisons with existing products. Alves then went on to speak about results obtained between 2000 and 2013 to illustrate the crisis of innovation. The majority of new medicines add nothing new, are not responding to medical needs, according to their research. 14 per cent of them are even worse in safety and efficacy, bringing no advantage/benefit. She noted that over the past 13 years, 65% of all new medicines have had no real added therapeutic value. Less than 20 per cent of new medicines have some possible therapeutic added-value. These results are consistent with those of many other institutions and research centres.

Alves then argued that clinical research mainly funded by companies does not enough focus on unmet needs; aims to obtain a marketing authorisation without the need to prove therapeutic advance; and clinical trials tend to be used as marketing tools. At the same time, marketing approvals are given faster and faster; often based on weak evidence, with often insufficient post marketing risk minimisation measures and dangerous drugs being approved and subsequently withdrawn. She expressed serious concerns over the EMA’s adaptive licensing project which in her opinion can have dangerous implications for patients.

With regard to high medicine prices she explained that prices are often negotiated in opacity and not frequently based on real cost of production which remains unknown. There is also a disconnection between the drug price and its therapeutic value. She further explained that influential oncologists have described current prices of cancer medicine as “astronomical, unsustainable and even immoral”. These prices therefore put universal access and health protection systems at risk. Furthermore, money spent for expensive drugs with little added-value is money wasted for what is really needed by society.

Teresa Alves then illustrated her presentation with the case of Sofosbuvir treatment against hepatitis C. While Prescrire recognises that the new medicine offers an advantage, she noted the essential contribution of publicly funded research for its development. Furthermore, she compared estimated production cost of 100 USD per patient to the 84.000 USD cost per patient per treatment. She said that the clinical trials were just enough to obtain the marketing authorisation and that there is little data about long term adverse drug reactions and drug interactions. The company justifications for this high price are about expected savings in medication use, transplants and hospitalisation, she explained. However, Alves highlighted that this forecast has been contested and that these savings would be obtained in 20 years if severely-ill patients were to be treated. She further noted that Sofosbuvir is under a voluntary licence in 91 countries but stated that this might simply be a window-dressing exercise since numerous other countries are excluded. Finally, Alves explained the high price Gilead paid to buy Pharmasset, the developer of the drug, in 2011 for 11bn dollars, and the need to recoup investment. She emphasized that Gilead paid 139$ per stock in 2011 for Pharmasset, while Pharmasset’s value in 2005 was only 5$ per stock.

Alves presentation concluded with suggestions about what is needed. First is to rethink the R&D system, with more research into unmet medical needs, more comparative clinical trials to demonstrate therapeutic advance compared to existing medicines, more publicly funded research and to set prices that reward real innovation. This would also mean to refuse exorbitant prices, use flexibilities such as compulsory licences, and demand evidence of therapeutic advance as criteria in marketing authorization. Finally, that would also mean opening the “black box”, with transparency and access to clinical, regulatory and pricing data, allow independent analysis and information sharing, encourage public scrutiny and identify real innovation.

Prof. dr. Graham Dukes, University of Oslo said that there is waste of money that could be used for good purposes. High medicine prices are demanded and accepted because of the widely propagated belief that the industry is committed to high research costs and that research record is proven successful. However, when in the US, the Security and Exchange Commission examined drug companies data, it found out that on average, only some 13 per cent of company revenues were spent on research while 48 per cent went on administration, marketing and profits. He continued by giving the example of an American firm that argued before a Dutch court that the cost of cancer drugs reflected research expenditure, while it actually happened that the costs had been supported by US public funds. The Dutch court accepted the claim that it would be seriously disadvantageous if a generic company was allowed to produce the same drug at a lower price. The legend that drugs cost a lot to develop is, amongst others, propagated by the Tufts Center for the Study of Drug Development which has the purpose of providing the drug industry with arguments to justify prices when dealing with the authorities. It has produced highly biased reports over the years. In his view, this Centre should have been closed down ages ago by an honest industry. The best and most sensible and successful critical approach of pricing is the one existing in Australia, Prof. Dukes continued. Producers were obliged to price the products at the same level of that of existing generic or other drugs long on the market, unless be proven that the products was better, safer or had other advantages. It brought down and kept low prices, but had to be abandoned following elections when an industry-sympathetic lobby acquired power. Using American data in matters of drug pricing and costs can be useful but it would be better to have EU data, he explained. We could, in a number of countries, secure reliable data of the cost to develop drugs and how companies are spending their money. More transparency is needed on the way money is used and how it could be improved. Prof. Dukes then underlined the possible merits of pooled procurement, a system that could have two or three countries working together.

Prof. Dukes then raised the issue of uncritical prescribing, with some doctors over-prescribing due to the pressure of commercials or patients, who believe that they have to come back from the doctor with a prescription. The commercial person is of no need, a financial burden on the community, he said. The result of its work is in over prescribing and waste. There is a solution tried on small scales, the employment of persons sent out by authorities or impartial bodies. They are credible and successful. Commercial detailing would be prohibited and then taken over by employing people providing unbiased, reliable information. Doctors do need information like this. At least, this could provide a mean of keeping the doctors properly informed. The approach is popular among doctors and highly appreciated. As for the patients’ pressure, there is no quick solution but it is a matter of education. But this belief needs to be progressively eradicated.

Ellen ‘t Hoen asked about better transparency of pricing in the EU and the role of the European Commission. Considering the suggestion made this afternoon regarding new models for R&D, would it be possible with the resources of the Commission spent on the pharmaceutical industry to pilot these new models and try them?, she asked. Moreover, she asked what role the Commission can play in ensuring transparency in drug pricing.

Thomas Heynisch Deputy Head of Unit, Food and Healthcare Industries, Biotechnology, DG ENTR said that on drug pricing, article 168 of the Treaty gave clear responsibility to Member States when it comes to management of health care. This is the basic line. Recalling the question on transparency, he explained that the remit of the Commission services was limited. There is only one available instrument and that is the Transparency Directive. The Commission appreciated the support from the Parliament when trying to amend the Directive, however it is currently stuck in the Council. Generics can play a major role in reducing cost, everybody agrees, and the Commission called for speedy pricing and reimbursement decision for generics, but with no endorsement from Member States so far. Everybody agrees too that the linkage between intellectual property and pricing and reimbursement decisions are not conducive to early access. This was also in the Transparency Directive. Heynisch continued on the issue of biosimilars, which can play a major role in driving down treatment costs. The Commission is trying to promote the acceptance of biosimilars as a way to have high quality medicines available in Member States while respecting Member States role and the roles of the value chain including prescribers. He noted that the last presentation referred to the question whether prescribers are informed about the properties of biosimilars. With regard to orphan drugs that tend to be costly, the role of Member States is again clear. DG ENTR launched a working group to promote cooperation among Member States, but noted that Member States are equally defending their turfs. One of the concrete outcomes was that the Commission managed to convince several member states to engage in further activity. It fosters the cooperation among member states.

On non-availability of medicinal products in Member States, this requires a detailed analysis. They had a working group and after having conducted a survey with competent authorities, it appears that is not the costly products that seem to be in needs, the problem coming from the availability of low cost products.

On adaptive licencing, there are concerns, but the phenomenon to push for off-label use comes because of cost containment. Adaptive licensing if done properly requires the involvement of the authorities. On the Innovative Medicines Initiative, he explained that the funds are not available to big pharmaceutical companies but SMEs and academia. He stressed that public money is not going to big pharma.

He agreed that they should have a closer look at alternative models and they want to have a comprehensive approach. He encouraged interested parties to ask the Commission to have a closer look at these models. Recently, they asked participants in the Rome meeting to come with concrete priority topics-deadline is the end of this month. The Commission is open to suggestion on areas where the Commission should be more active.

Nessa Childers (S&D, IE) summed up the meeting as she had to join the plenary session. She began by saying that the situation in Ireland wasn’t fine, especially in the case of health services. Access to healthcare and pharmaceuticals was not good in the first place even before the crisis she explained. There are long waiting lists in public health services for diagnoses. Access to healthcare is a public good, she stated, this is also a human right. On the Member State competence claim, she responded that in a country like Greece, it is no question that this is a breach of rights set in the Treaty. Breach of human rights is not a competence of Member States, it has to do with the whole of Europe. Mr Berdougo explained that the wide coalition built achieved results. She then explained that one thing worked in politics, it is fear of politicians that they would lose their seat. Civil society also has to expose the power of lobbyists. She called for a wide coalition in the health area, so that governments would begin to reinvest money, which had been taken out of the system. She concluded by insisting on the question of human rights and the breach of the Charter of Fundamental Rights in Greece when it came to access to public health services.

Dirk Van Den Steen, Team leader Healthcare systems unit, DG SANCO explained that the Commission did understand that there is a problem, this is why the Commission put out a Communication on Health Systems where medicines are singled out as a specific area where there are concerns. This is Member States’ territory so the Commission could support Member States that proposed initiatives such as the one from France. He further indicated that the Commission supported the work of the Council reflection process on responsible health system and that the health programme included an action on reference pricing. This is one way of helping the debate. They had similar initiatives in the new health programme looking at pricing models. The Commission looked forward to the outcome of the discussion in the working party on pharmaceuticals and medical devices on innovation for the benefit of patients that should see council conclusions in December 2014.

Merel Philippart,Universities Allied for Essential Medicines (UAEM) asked why society is dependent on pharma companies, while most innovative medicines are a result of publicly funded research. She said that society pays twice both for the research but also for the high prices. Why can’t states fund their own production? she asked.

David Preece, European Association of Hospital Pharmacists (EAHP) said that the problem of shortages was affecting access in hospitals for new innovative as well as generic medicines covering a wide area. They would issue a report in the coming week.

A representative from the European Haemophilia Consortium asked the European Commission representatives whether the legal instrument of joint procurement had already been used and were there plans to use it for hepatitis C treatment or other diseases.

Evangelia Kikeleki, member of the EESC also member of a consumer organisation spoke on behalf of the consumers against the transfer of responsibilities for medical devices from DG SANCO to DG ENTR. Juncker said that health was not for sale and could not belong to DG ENTR. She also asked about the risks brought about by the current discussion on TTIP.

A representative of the European association of pharmacists commented on the absence of debate on the impact of TTIP on access to medicines.

A representative from the European Platform for Patients’ Organisations, Science & Industry asked the question whether there are enough patients involved. He said he had not heard anything on bringing orphan drugs to the patients as well as on the EU/US agreement (TTIP).

Prof. Dukes replied on own R&D that it has been done to a small extent, mentioning centres in San Francisco and Strasbourg working on drugs set aside by big companies. These groups are promising. Other proposals have been made to establish further groups, he indicated. It can be done but so far only on small scale.

Alves on TTIP referred to a paper published by a coalition of NGOs. There are a lot of strings attached, putting access to medicines and health at risk. She agreed that TTIP is a clear and present danger.

Love thought that TTIP was a threat to health in Europe. What is needed is to demand for negotiations not to be secret while it was not for a lot of lobbyists in the US. On patient groups, he explained that in the US, the typical situation was that patient groups were focusing on reimbursement policies and to make sure people were covered, but not challenging prices directly. He also mentioned that in many cases patient groups are heavily influenced by big pharmaceuticals. He criticized the Commission for not stepping up the fight against the high prices of innovative drugs. The EU has an interest to protect itself from high prices of cancer drugs, he added.

Heynisch assured everyone that the European Commission never had the intention to jeopardise access to medicines in Europe. Certain requests with regard to including pricing and reimbursement issues in the TTIP negotiations are not endorsed by the Commission as they had to have a closer look at the different healthcare systems on both sides of the Atlantic. The incompatible approach to coverage and financing does not make a convincing argument in engaging in discussions on this within TTIP because it might end up with a one-way street.

Additional sources of information:

  • TACD resolution on access to medicines (A2M), November 2014

http://tacd.org/new-resolution-on-access-to-medicines/

  • TACD, HAI Policy Paper “Time for the EU to lead on innovation: EU policy opportunities in biomedical innovation and the promotion of public knowledge goods”

http://haieurope.org/wp-content/uploads/2012/04/HAI-Europe_TACD-EU-Innovation-Paper.pdf

  • Update: TTIP Civil society response paper to Big Pharma wish list

http://commonsnetwork.eu/new-coat-ttip-civil-society-response-paper-to-big-pharma-wish-list/

  • HAI Europe Recommendations: Keys to improving access to, and the rational use and

good governance of, medicines in Europe

http://haieurope.org/wp-content/uploads/2014/10/HAI-Europe-recommendations-to-improve-A2M.pdf

  • Trading Away Access to Medicines (Revisited) – New report from HAI Europe and Oxfam

http://haieurope.org/wp-content/uploads/2014/09/Trading-Away-Access-to-Medicines-Revisited.pdf

  • Europe for access to medicines & public health care-10 commitments for the new European Parliament, November 2014

http://saludporderecho.org/wp-content/uploads/2014/11/DECALOG-eng.pdf