A victory for medicine trial transparency but there is still a long way to go

 

 canScience

 

The European Parliament voted on Wednesday the adoption of the new Clinical Trials Regulation, which has removed the legal framework on commercial confidentiality that previously allowed pharma not to publish its data. With the new Regulation information from trial study reports on the efficacy and safety of new medicines should not be considered commercially confidential.

 

The Regulation also requires, among other things, that

 

  • all drug trials in Europe are registered on the publicly accessible EU clinical trials register

  • a summary of the results — “understandable to a lay person” — from these trials is published on the register within a year of the trial’s end

  • Clinical Study Reports are be made publicly available, and that

  • a new, publicly accessible EU clinical trials register is set up and run by the European Medicines Agency (EMA).

 

This new EU transparency policy goes significantly beyond the FDA´s policy in the US (similar to the initial European Commission proposal for the Regulation) that only requires a summary of the trial to be publicly available. The most important improvement is that it mandates the publishing Clinical Study Reports (CSRs), which are comprehensive documents presenting clinical trial results in a detailed and structured manner, thatshould not be considered commercially confidential once a marketing authorisation has been granted, the decision making process on the application for a marketing authorisation has been completed, or an application for marketing authorisation has been withdrawn(Recital 20a).

 

This victory for transparency is only partial. It only applies to new medicines starting in 2016 and a number of large and dangerous loopholes remain. As well, Big Pharma has announced that they will try to influence the implementation of the Regulation to restrict the new pro-transparency rules. The European pharma industry association, EFPIA, has said that “[It] is critical that the Commission and EMA interpret the Clinical Trial Regulation in a manner that respects patient privacy, the integrity of regulatory decision-making, and incentives for companies to make long-term investments in biomedical research.

 

 

Some of Regulation´s loopholes are the following:

 

- It fails to mandate that investigators (clinicians) and not the industrial sponsors report all serious adverse reactions to health authorities, whether they are “expected” or “unexpected”, meaning that safety data can still be withheld.

 

-It allows for “low intensity trials”, either post-authorization or “off-label”, and “non-commercial” trials to have much lower reporting requirements.

 

-It fails to require comparative clinical trials so that the new medicine would be compared with the reference (“gold standard”) treatment, as opposed to only a placebo, in order to determine whether it has a therapeutic advantage over existing treatments.

-It does not mandate the public registration of all individual trial patient data.

 

 

The transparency camp will have to be vigilant throughout the long implementation process of the Clinical Trial Directive to assure a positive, pro-public health interpretation of the legislation. The Pharma industry will continue lobbying the EU institutions and the EMA heavily in the opposite direction.

 

 

Unfortunately, other threats to clinical trial transparency are looming. In the coming months the European Parliament will be considering the Trade Secret Directive that could have a devastating impact on transparency by re-affirming commercial confidentiality as a legal imperative. We must also be conscious of the negotiations of the EU-US Free Trade Agreement, TTIP, that is also discussing new transatlantic rules proposed in Big Pharma that would roll back any gains made in the present regulation.

 

 

The new Clinical Trial Regulation has been a partial but significant victory for civil society, socially committed medical professionals and the independent scientific community. This coalition must stay organized if we wish to move forward an ambitious agenda for medical science based on evidence and public health needs.

Text of Clinical Trial Regulation: http://register.consilium.europa.eu/doc/srv?l=EN&t=PDF&gc=true&sc=false&f=ST%2017866%202013%20INIT:

 

 

Students forge new thinking on access to medicines and innovation

 

Universities Allied for Essential Medicines (UAEM) is a promising and inspiring international student network focusing on access to medicines and biomedical innovation. They have a  strong presence in the US and Germany and are growing all over Europe with local chapters. Most of them are undergrad medical students even though there are law and global health students involved as well.

 

The conference entitled “Shooting up-Raising expectations about R&D” organised by the UK branch on 25 January 2013 in UCL had a great line-up of prominent speakers among whom Nobel laureate Sir John Hulston, Katy Athersuch (MSF Access Campaign), James Love and David Hammerstein (http://www.youtube.com/watch?v=141b9vyTkWU). The conference came at a very timely moment, just days after the remarks by Bayer CEO Decker who stated that a new cancer drug is not for Indians but for western patients who can afford it and in the midst of the pharmagate scandal in South Africa over Pharma lobbying against lower prices for life saving medicines.   Sir Robin Jacob, Professor of intellectual property Law at UCL opened the conference explaining that patents are not to be blamed for the problems we are faced with today in accessible and affordable medicines but instead patentes are fermenters of innovation. He also critisized compulsory-licensing as well as strict regulation but was unable to give any concrete answers  when asked about the serious access to medicines crisis in many parts of the world, rich and poor. He defended the wildly exaggerated 1bn myth regarding the cost of the development of a each new drug, belittled the contribution of pubic research funding and stood firmly by the view that there is no alternative solution to strong patent monopolies.  

 

All the other speakers opposed Sir Jacob´s strong pro-IPR stances and their over arching theme  was that public health should not be treated as any other commodity but as a common good which needs to be available to everyone. Many of the problems that societies have to cope with today, in terms of affordable, access to medicines, stem from the current IP-dominated medical innovation model which is obviously broken and is no longer delivering the medicnes people need.  To put it simply, patents create monopolies which skyrocket drug prices. It was also clear that access to affordable life-saving treatments is no longer a problem of the developing world as big pharmaceutical industries tend to present it. but It  affects affects large parts of the developed world including the US and Europe. As Sir Sulston put it “in improving justice in health, we contribute to the future of humanity”. Moreover, he emphasized the importance of scientific research as through science we understand ourselves better.In this respect, he sounded the alarm in relation to the fact that research carried out by universities is increasingly linked to and guided by commercial interests. This is why; he stressed a) the need to rebalance scientific research toward the public interest  and b) the promotion of open data and open science so as to fully take advantage of the potential of public investment. He criticized the fact that what is expected today from non-profit funding of research is actually making profit through patents. He added that this profit is not reinvested in further discovery but on the contrary, it is channelled into marketing, publicity and into coercing government and international officials.  

UAEM’s initiatives are very worthwhile and serve multiple purposes as  they fully support an open, health needs-driven innovation model that favour access to medicines as opposed to closed, market-driven patent monopolies.  Hundreds of future health professionals are forging a fairer future for affordable, high quality biomedical innovation.  They are trying to place patients before patents, health before profits, a moral imperative on which millions of lives depend.

 

Yannis Natsis, TACD

Patients before Patents – Response to The Economist by MSF and Oxfam

 

Protect patients, not patents

SIR – You argued that “protection should not be weakened” on pharmaceutical patents (“The new drugs war”, January 4th). Drug patents protect drug-companies’ profits, not patients. The industry promotes several myths to justify its outlandish prices, such as that it costs $1 billion to develop a new medicine, that private companies pay for all drug R&D costs (government and tax-subsidised institutions contribute heavily), that stronger patent protection equates to more innovation and that people in America and Europe must subsidise the rest of the world’s medicines.

The truth is that pharmaceutical companies charge high prices and reap enormous profits because they can. Tiered pricing not only blocks access for most of the world’s poor, it also does nothing to bring down costs. As a medical organisation providing treatment for tuberculosis, HIV and other diseases, it has long been clear to us that the current system for medical innovation is broken. Today, millions of people in both rich and poor countries are staring at a steady wave of diseases that come with age, and realise they can’t afford to pay for the medicines to treat them.

The Trans-Pacific Partnership trade deal in its current form will only exacerbate this growing health crisis by allowing drug firms to extend monopolies beyond the 20 years already guaranteed under global trade rules, as well as limiting governments’ ability to regulate prices.

Rohit Malpani
Médecins Sans Frontières Access Campaign
Geneva

* SIR – The amount of money pharmaceutical companies report to spend on researching and developing new medicines is notoriously secretive. Companies tell us they spend $1.5 billion annually, but this information (based on a single study funded by the companies themselves) has not been independently verified.

Also, the pharmaceutical industry has been pricing its patent medicines differently in developing countries for decades, yet despite companies’ claims to the contrary these products have not flooded American or European markets.

Developing countries rely on generic medicines to meet their needs, and not off-patent branded medicines as your article claimed. You praised Roche for selling its products cheaply in Egypt but did not mention that they only did so after an Egyptian generic company, Minapharm, manufactured and sold drugs at a third of the original price..

Dr Mohga Kamal-Yanni
Senior Health Policy Adviser for Oxfam
Oxford

FOR A TRANSPARENT, INNOVATIVE AND JUST RESPONSE TO THE CRISIS IN SPANISH PUBLIC HEALTHCARE”

MADRID event a2m 20-1-14

NEW EXPERT AND CIVIL SOCIETY WORKING GROUP LAUNCH

The Working Group on Health, Medicines, and Innovation has been launched with the goal of offering inclusive and constructive recommendations on the evaluation of health access, transparency, the management of expensive patented medicines, and the promotion of new innovation models in favor of the common good.

Madrid, 20 January 2014. Today, the Working Group on Health, Medicines, and Innovation, an initiative made up of a group of organizations and experts from various fields, publicly presented their objectives in an event entitled “Access to medicines and innovation in times of crisis” which took place at the Ateneo de Madrid. This morning, the group met with political parties and institutions to present their manifesto and explain their main concerns. In addition, scientific and professional associations, pharmaceutical companies, NGOs, representatives of the innovation area of the Ministry of Economy and Competitiveness and the Community of Madrid and patient associations, among others, also participated in the event.

Among the promoters of the working group are members such as the Confederación de Consumidores y Usuarios, Médicos del Mundo, Salud por Derecho, Trans-Atlantic Consumer Dialogue, Farmacéuticos sin Fronteras, No Gracias, and the experts Joan Rovira, David del Campo, Judit Rius and Xavier Seuba, and it is intended that more organizations and individuals join the initiative soon.

Vanessa López, director of Fundación Salud por Derecho, explains “The group emerged as a response to an unjust and ineffective management of the crisis, but also because of the structural and traditional weaknesses found in the processes of research, development, regulation and commercialization of medicines, not only in Spain, but also on a global scale.” The working group intends to look at the problem from a comprehensive perspective, because as López says: “The inequity in access to medicines that patients have always experienced in impoverished countries and the lack of research on so-called neglected diseases, is now linked to a growing concern about the sustainability of the system in high-income countries and the quality of innovation.”

David Hammerstein, policy advisor to the organization Transatlantic Consumer Dialogue declares that “A just and participatory response to the crisis requires much more transparency about public spending, as well as the prices paid in the purchase of medicines, and the rigorous evaluation of the efficacy and safety of the medicines and, in general, the actual impact of healthcare cuts.”

The lack of information on most aspects related to medicines, especially those that relate to clinical research, transaction prices, relations between the industry and prescribers, the motivation of regulatory decisions, pricing, public funding, etc.., is an area identified by the Group as a fundamental problem. Abel Novoa, president of No Gracias affirms that “It is necessary to shed light on the generation, dissemination and application of clinical knowledge, because transparency in medicine saves lives,” and he adds: “The lack of transparency goes against the health of citizens, social equity, and professional and ethical obligations including those of innovation itself.”

Also missing are formal and independent studies that assess the impact of the measures taken by the Government, but there is convincing evidence that access for the most vulnerable groups has been substantially affected. In this respect Stefan Meyer, associate director of Médicos del Mundo maintains that “Copayments are unfair because they affect more those people with fewer resources and inflict an additional punishment for the sick. Also, they are ineffective because they do not generate savings or encourage a more rational use of medicines.”

From the holistic perspective that the working group employs, the problem starts during the research and development of medicines. Joan Rovira, professor emeritus of economics at the University of Barcelona and medicines policy expert argues that “Biomedical R&D must be adequately funded and it is likely it requires more resources than are currently being dedicated; but, this must be done with mechanisms and incentives to ensure that new innovations pose a real contribution to health and social welfare and facilitate equal access to them.”

Some of the recommendations already made ??by the Working Group are the following: 1. The independent evaluation of the impact of the healthcare cuts and the introduction of corrective measures. 2. The publication of key information about medicines, such as the prices paid by the different administrations. 3. Changes in the biomedical innovation model to orient it toward health needs and to prevent the privatization of knowledge generated by public investment. 4. Creating a transparent and participatory government agency to evaluate the efficacy, safety and cost-effectiveness of pharmaceuticals. 5. Consider the possible use of compulsory licensing as a potential tool to ensure a balance between the rights of the innovator / owner of the rights and those of society.

Civil Society demands fair solutions to Greek health crisis

 

There is a fully-fledged access to health care crisis in Greece as a result of the Troika-dictated cuts over the past four years. Three million people or more, exact figures are hard to get due to “Greek statistics”, have fallen off the social safety net and have lost any access whatsoever to health care services in the country. This is easy to understand as according to Greek legislation long–term unemployed i.e. over a period of two years lose their social coverage.

 

Needless to say that the situation is dire as far as vulnerable social groups are concerned such as immigrants, children, the elderly, asylum seekers, roma and others. This was one of the issues highlighted at the 2nd policy-making conference organized by the TransAtlantic Consumer Dialogue (TACD) in Athens on 13 December 2013. TACD joined forces with the European Public Health Alliance (EPHA), Médecins Sans Frontières (MSF), Médecins du Monde (MdM Greece), PRAKSIS NGO, Greece’s leading consumer association TACD member EKPIZO, the Greek cancer patients’ association DEDIDIKA and MEP Nikos Chrysogelos (Greens/EFA, EL) in analyzing the latest developments in the fields of medicines and health. The shocking data presented by President of MdM Greece is indicative of the bleak situation. She emphasized that there is a 20% annual increase in the number of people using the various services of MdM Greece. Vaccines constitute the number one type of medicine that people who turn to MdM Greece ask for. In fact about 30% of children in Greece need to be vaccinated.

 

What was striking was the inability of the Troika’s & the government’s representatives present at the conference to come forward with concrete proposals on how to improve the situation on the ground. Moreover, it became apparent that there is disagreement between the two sides as to the budget allocated to pharmaceutical spending for 2014. The Troika insists in reducing public spending further to 2bn euro while the Greek government pushes for maintaining the budget at the same level as in 2013 i.e. 2,3 bn if not increasing it to 2.5 (5 bn in 2009). Responding to harsh criticisms, the Troika representative acknowledged that “in the ideal world, there should have been impact assessment studies for the reforms introduced”. On another front, it was clear that the government in its efforts to reduce spending is pushing hard for generics. Use of generics remains extremely low around 20%. Nevertheless, several interest groups for various reasons try to prevent this from happening mainly by instilling fear within Greek society concerning generics’ safety and quality. The author of the latest medicines’ pricing law gave a detailed presentation of the highly controversial piece of legislation which grabbed headlines for weeks as opposition parties accused the government of serving foreign pharmaceuticals’ interests and wiping Greek pharma companies off the map. The overall conclusion regarding the new law is that it promotes generics and reduces drugs’ prices further both for patent and off patent products. Civil society representatives asked the Greek authorities to consider options such as pooled procurement at the EU level as well as the use of compulsory-licensing for providing people with access to affordable treatments.

 

The conference was followed by an advocacy capacity building workshop for patient groups from all over Greece. The country’s civil society remains fragmented and disorganized. Additional serious challenges remain: a) Patient groups do not focus on long-term strategic goals & planning because they are preoccupied with resolving their day-to-day problems and b) there are constant developments in the health sector and numerous issues added to the agenda making it difficult to prioritize and coordinate. Nonetheless, participants acknowledged that they have reached a “now or never” point and they need to forge alliances and overcome their divisions.

 

Civil society empowerment and pressure on the Greek government will continue in the coming months especially in light of the ongoing Greek Presidency of the Council of the EU (first half of 2014).

Yannis Natsis

 

 

 

 

Notes from a generally non-informative “civil society” meeting on TTIP

 

Brief chronicle of an obscure, scarcely informative “civil society” meeting on the TransAtlantic Trade and Investment Partnership in Brussels on January 14th, 2014

 

A few tidbits of Commission statements:

 

The European Court of Justice might “not be impartial to judge the legality of the Investor-State Dispute Settlement that affects 3rd parties like the USA because ECJ Justices are appointed by EU Member States.”

 

You can rest assured that we have the Pharmaceutical industry wish-list http://tacd-ip.org/archives/1138 is very present in the negotiations.”

 

The free flow of data across the Atlantic has nothing to do with data protection or privacy.”

 

I stand by my (Pedro Velasco) statements about the TransAtlantic Consumer Dialogues negative anti IPR positions in TTIP.” (upon being asked about his declaration to a business meeting on TTIP that the TACD meeting he attended was “unpleasant to see” and that “industry should worry about this consumers group.”)

 

 

There were over 200 people present in the “TTIP Civil Society Meeting” organized by the European Commission on Tuesday in Brussels. Over 90% were industry representatives. There were many good, concrete questions but practically no clear answers about the real content. Most answers were merely nominative and evasive. At no point does the Commission tell the audience its concrete positions on any issue. There were no questions posed to the Commission on the issue of transparency.

 

The Commission stated that the first phase of the negotiations was over in which the topics to be covered and the process were agreed upon. Discussions on ISDS (investor-state dispute settlement) were only beginning. One EU industry representive sentenced that there would be no TTIP without ISDS.  Intensive discussions on pharmaceuticals were already taking place. They would press the issue of geographical indications for wine and other products. Healthcare and other universal services have not been discussed yet in the context of public procurement. Labour, energy and environmental norms were on agenda but no real information was given on the EU positions.

 

 

Big Pharma´s leaked wish list for TTIP EU-US trade pact

PhRMA/EFPIA priorities for TTIP.

I. Regulatory issues :

Greater regulatory convergence:
Ø  a built-in agenda allowing for progressive greater regulatory convergence over time.
Ø  a Working Group on Pharmaceutical and Medical Devices as platform to discuss implementation issues and address joint approaches to future compatibility topics.

Single development plans
Ø  for submission in EU&US for pediatrics;
Ø  extend the current EMA/FDA parallel SA
Ø  adopt the EMA/FDA pilot project for parallel assessment of Quality by design (QbD) application
Ø  address duplicative clinical testing requirements (via revision of ICH E5)

Other areas of convergence
Ø  establish harmonized list of clinical trial result data fields & agree on which may be disclosed to public (uniform protection of confidential commercial info & trade secrets)
Ø  develop therapeutic area guidelines (beginning with specific treatment areas)
Ø  EU and US to ensure that national/regional coding systems are based on common standards for the use of unique identifiers, developed using non-proprietary, harmonised international standards.
Ø  add a pharmacovigilance cluster to conduct work on post-marketing testing & risk management requirements
Ø  establish common framework & methodology for benefit-risk assessment, but retaining authority to make different risk assessment judgments
Ø  mutual recognition of GMP inspections

II. IPR :

Ø  PhRMA: seek patent term adjustments for patent office delays in the EU
Ø  PhRMA: seek forms of patent linkage in the EU
Ø  EU/US aligned approach re disclosure of clinical trials data (impact on commercial opportunities in third countries should also be considered)
Ø  Harmonization on the grace period
Ø  EU/US systems should be open to further adaptation to incentivize research into unmet needs
Ø  Include commitment to shared principles regarding patentability standards
Ø  Extension of data exclusivity(DE) on biologics in EU up to 12 years (despite in US it is 4ys DE and 8ys Market Exclusivity)
Ø  Establish a benchmark for not limiting the use of trademarks other than to protect public health

III. Market Access & Transparency:

Ø  P&R policies should take into account innovation
Ø  when products are grouped for P&R purposes, it should only take into account bioequivalent products
Ø  when external reference pricing, only countries that are similar in terms of their socio-economic level, purchasing power, populations, disease burdens and health care system should be taken into account; bailout countries while they are undergoing fiscal restructuring programmes should be excluded from any referencing
Ø  any reimbursement controls/determinations should apply only to products dispensed and reimbursed in that Party
Ø  To avoid that pricing & reimbursement (P&R) policies hamper trade between EU/US
Ø  include a pharma annex on P&R policies that promote transparency principles in processes & and reward innovation
Ø  Procedural safeguard in government P&R
Ø  specified time-limits for pricing and/or reimbursement decisions
Ø  individual decisions containing a statement of reasons based on objective and verifiable criteria provided to applicants
Ø  legal remedies for applicants

IV. Other chapters:

Ø  Public Procurement: building on GPA, a comprehensive chapter with rules on transparency & non-discrimination of public proc. practices at federal & sub-federal level (offensive interest for EU)
Ø  Customs: full liberalization of tariffs and  pursuit of simplified and rational RoO based on common defined chemicals & pharmaceutical processing activities
Ø  Third countries: coordinated approach for trade policy objectives in third countries: joint principles on regulatory harmonization, transparency measures, IP and tariff elimination and coordinated approach to be leveraged at multilateral level when feasible: WTO, OECD, ICH, WIPO

Acceso a medicamentos e innovación en tiempos de crisis

20-1 madrid

Durante los últimos meses un grupo de organizaciones y expertos entre los que se encuentran la Confederación Española de Consumidores y Usuarios, Médicos del Mundo, Salud por Derecho, Trans-Atlantic Consumer Dialogue, Farmacéuticos sin Fronteras, No Gracias, Joan Rovira, David del Campo y Xavier Seuba hemos emprendido la creación del Grupo de Trabajo sobre Salud, Medicamentos e Innovación (GTSMI).

El GTSMI surge de la preocupación por el impacto que algunas medidas adoptadas para afrontar la crisis económica y financiera están teniendo en el acceso a los servicios de salud y a los medicamentos en Europa; sobre todo en los países más afectados por la crisis, como es España. Además de la coyuntura actual, el Grupo también fundamenta su creación en las debilidades estructurales del proceso de investigación, desarrollo, regulación y comercialización de las tecnologías sanitarias, no sólo en España, si no a escala global.

El grupo fue reunido por primera vez en diciembre de 2012 a propuesta de Salud por Derecho y TACD y el 20 de enero hará su presentación pública en el evento “Acceso a medicamentos e innovación” que se celebrará en el Ateneo de Madrid desde las 11:00 a 14:00 y en el que esperamos poder contar con su participación.

Adjunto en este correo puedes encontrar la agenda provisional del evento.
La asistencia al evento es por invitación, por lo que si desea asistir le rogamos se ponga en contacto con nosotros enviando un correo electrónico a: saludporderecho@saludporderecho.org

Agenda Provisional GTSMI – 20 enero

TTIP: Full transparency, nothing less

We are in the midst of the mother of all trade negotiations. The EU and the US have already celebrated the second round of the Transatlantic Trade and Investment Partnership (TTIP). This is not your ordinary free trade agreement that focusses on tariffs and protectionism but a game-changing attempt to find common denominators for environmental, health, food, energy and medical regulations on both sides of the Atlantic. It’s obviously about issues of the foremost public interest. But as mind boggling as it may seem, it’s precisely the public that is not allowed to find out exactly what the negotiations are about…

According to the European Commission “All documents related to the negotiation or development of the TTIP agreement, including negotiating texts, proposals of each side, accompanying explanatory material, discussion papers, emails related to the substance of the negotiations, and other information exchanged in the context of the negotiations (…) will be held in confidence.” But what does “held in confidence” mean?

“In confidence” means accepting that the US gives real time access to TTIP negotiating texts and documents to the largest 700 US industries, most of which operate in the EU. It means that these companies can give concrete legal wording suggestions directly to the negotiators while transatlantic civil society organizations and the general public cannot.

Even former US chief trade negotiator Robert Zoellick complained about the rationality of this policy: “Frankly, that always surprised me that draft trade texts were seen by hundreds of people anyway – government officials, advisors and lobbyists. So, why not simply put the information online?”

A recent article by the New York Times shows how the European Commission consults industry lobby groups in the preparation of the TTIP talks. The basis of the article was internal Commission files requested via the EU access to information laws by the New York Times and Corporate Europe Observatory. The pretty explosive documents acquired show the incredible privileged access that corporate industry is granted by the Commission over the agenda of the trade negotiations, as well as the big business agenda to use TTIP as an almost revolutionary tool in the way that legislation will be written in the future.

Moreover, EU Trade Commission De Gucht has candidly said that the reason to focus so much on “technical barriers to trade” and to build this chapter on the five pillars of the automotive-, chemical-, pharmaceutical, medical, and ICT industries is because these sectors offered input as to what they wanted out of a TTIP deal. It leaves us wondering why other stakeholders have not been involved to that same degree.

Both EU and US trade officials are constantly claiming the highest degree of transparency and citizen participation. Nevertheless, the reality is that without texts being made publicly available it is virtually impossible to provide appropriate consumer and citizen input or feedback for these crucial trade negotiations. Without access to precise wording the real social, economic and environmental impacts will remain unknown to the public. And currently, the signs we do get, point in the wrong direction. As the devil is in the details, in TTIP negotiations the public should be given an adequately long spoon to eat with the devil: full transparency, nothing less.

An informed debate means that the issues and the texts are on the table for all to see. So far support for TTIP is high in the general public according to a PEW poll. But remember ACTA: the public in the end will not buy a pig in a poke.

Reinhard Buitikofer, Member of the European Parliament

David Hammerstein,  TransAtlantic Consumer Dialogue

Event summary: Greek Society demands fair access to medicine solutions

 

 

 

Access to medicines crisis in Greece: Society demands fair solutions

 

European Parliament office in Athens, 13 December 2013

 

 

Event summary report

 

 

Conference Overview

 

 

  • 130 people showed for the event from all sectors (news agencies, medical associations, doctors’ associations, patients’ associations, pharmacists and numerous representatives of the pharmaceutical industry). The conference was attended by the parliamentary representative of the leading opposition party SYRIZA Mr. Panayiotis Kouroumplis. European Commission’s Task Force for Greece (TFGR) was represented by Ms Giulia Del Brenna who flew from Brussels. Moreover, presentations were given by the author of the latest law on medicines in Greece Mr. Maniadakis and from Mr. Charalambos Karathanos, pharmacist and close advisor to the Minister of Health Mr. Adonis Georgiadis.

 

 

  • Médecins Sans Frontières (MSF), Médecins du Monde (MdM Greece), PRAKSIS NGO, Greece’s leading consumer association and TACD member EKPIZO, the Greek cancer patients’ association DEDIDIKA, MEP Nikos Chrysogelos (Greens/EFA, EL) and the European Public Health Alliance (EPHA) all actively supported and promoted the event.

 

 

  • About 50 patients’ representatives coming from all over Greece attended the conference and participated in the afternoon workshop.

 

 

  • The conference’s webpage had 6.000 visits (10/11-30/12/2013) while 115 people registered in advance.

 

 

  • There were articles in the press leading up to the conference as well as a detailed report of the work of the conference on the same day published by one of Greece’s largest news portals (www.news247.gr). An article also appeared in one of the country’s largest dailies “Efimerida ton syntakton” on Monday 16 December 2013 (47.000 followers on FB). Overall, the event received considerable publicity despite the fact that on the same day, there was a major high-level conference organized in Athens by the Greek Ministry of Health in cooperation with the WHO and the European Commission’s Task Force (TFGR) on the heath reforms in Greece.

 

 

  • The event was webstreamed live. Intensive live tweeting took place the days before and on the day of the conference (twitter analytics).

 

 

  • Our save the date/invitation was widely circulated by the office of MEP Nikos Chrysogelos (Greens/EFA, EL), Médecins Sans Frontières (MSF), Médecins du Monde (MdM Greece), PRAKSIS NGO, Greece’s leading consumer association and TACD member EKPIZO (it was sent to its 23.000 members across the country) as well as by the Greek cancer patients’ association DEDIDIKA. In addition to the above, it was published in numerous news & medical websites (see indicative list below).

 

 

Health Daily (the country’s largest daily health newsletter reaching 7.000 professionals – the invitation & press releases were published 3 times leading up to the conference)

 

http://health.in.gr/news/various/article/?aid=1231279732
http://www.ygeia360.gr/el/news/item/8050-synedrio-gia-thn-prosbash-twn-ellhnwn-asthenwn-sto-farmako
http://health.in.gr/news/various/article/?aid=1231279732
http://www.infospoudes.gr/index.php?option=com_content&view=article&id=16816&catid=25028&Itemid=1209
http://www.almazois.gr/gr/index.php?option=ozo_content&perform=view&id=505
http://www.almazoispatras.gr/2%CE%BF-%CE%B4%CE%B9%CE%B5%CE%B8%CE%BD%CE%AD%CF%82-%CF%83%CF%85%CE%BD%CE%AD%CE%B4%CF%81%CE%B9%CE%BF-%CE%BF%CE%B9-%CF%83%CF%85%CE%BD%CE%AD%CF%80%CE%B5%CE%B9%CE%B5%CF%82-%CF%84%CE%B7%CF%82-%CE%BA/
http://www.mednet.gr/app/index.php/thenews/view/48
http://www.newmoney.gr/article/32350/synedrio-gia-tis-synepeies-tis-krisis-stin-prosvasi-sta-farmaka
http://www.blog.gr/articles/168584/Diethnes-sunedrio-kai-seminario-me-ton-titlo-Oi-sunepeies-tis-krisis-stin-prosbasi-sta-farmaka-H-koinonia-apaitei-dikaies-luseis.html
http://pharmateam.blogspot.gr/2013/12/blog-post_9125.html#axzz2oIT0z87c
http://www.life2day.gr/2013/12/sinedrioi-sinepies-tis-krisis-stin-prosvasi-sta-farmaka-h-kinonia-apeti-dikees-lisis/
http://pefni.wordpress.com/2013/12/04/%CE%BF%CE%B9-%CF%83%CF%85%CE%BD%CE%AD%CF%80%CE%B5%CE%B9%CE%B5%CF%82-%CF%84%CE%B7%CF%82-%CE%BA%CF%81%CE%AF%CF%83%CE%B7%CF%82-%CF%83%CF%84%CE%B7-%CF%80%CF%81%CF%8C%CF%83%CE%B2%CE%B1%CF%83%CE%B7-%CF%83/

 

 

Synopsis of presentations’ main points

 

 

Welcome remarks

 

 

In his opening remarks, MEP Nikos Chrysogelos (Greens/EFA, EL) spoke of the need to have a universal health coverage system in place. He emphasized the role of prevention as it reduces the future cost of treatment. He underlined the fact that there are many cases reported in Greece of people whose health has deteriorated considerably due to the fact that they either a) cannot afford to take their treatments properly or b) they do not have access to primary health care.

 

 

David Hammerstein, Senior advocate, TransAtlantic Consumer Dialogue, Brussels He highlighted the importance of the Greek Presidency of the Council of the European Union (first half of 2014). He referred to the budget reduction measures put forth by the European Commission for which there are no evaluation-impact studies. He described fight against corruption and transparency as key elements in dealing with medicines in Greece. Last but not least, he underlined the lack of concrete data regarding various dimensions of the health crisis in the country.

 

 

Eleni Alevritou, President of EKPIZO stressed the importance of collective action in times of crisis. She described the Greek civil society movement as a weak and disorganized one which nevertheless needs to better organize itself in order to become more efficient.

 

 

Policy-making session I: The situation on the ground in Greece concerning access to life-saving medicines moderated by David Hammerstein, Senior advocate, TransAtlantic Consumer Dialogue, Brussels

 

 

Dr. Kostas Athanassakis, Research Fellow, National School of Public Health (ESDY) gave an overview of the agreements between the Greek government and the Troika over the past years. He started by saying that public pharmaceutical spending will be reduced to 2bn euro in 2014 i.e. a 60% reduction in comparison to the 5bn euro spent in 2009. He then presented the basic reforms concerning medicines in Greece namely the active ingredient-based prescription and the prices of reference for the national insurance organization EOPYY. He explained that if the 2bn euro threshold is not respected, the agreements foresee additional measures such as increasing co-payment percentages as well as moving more medicines to the “negative list” i.e. list of medicines which are not reimbursed. According to the latest agreements between the Troika and Greece, generics will need to cover 60% in pharmacies’ sales and 50% of the use in hospitals. Moreover, he referred to all of the mistakes made in the operation of EOPYY which have resulted among others in many people losing their social coverage over the past three years. According to Dr. Athanassakis hospitals have become the primary focus of the reforms along with the future role of EOPYY. Since the start of the agreements, cutting pharmaceutical spending has been the top priority. This was to be achieved by a) slashing the prices of medicines, thus reducing the profits for suppliers and b) cost-sharing thus making things worse for patients. He commented that the cost-sharing tool is very common, can be efficient in reducing pharmaceutical spending (average co-payment in Greece before 2009 = 9%, today around 23%) but can also be extremely dangerous for health, as patients decide to forego certain types of medicines which leads to immediate worsening of their health status. Furthermore, deteriorating health conditions increase the cost of future treatment while chronic diseases become lethal as regimens are not taken properly. He concluded by saying that reforms introduced so far serve almost exclusively the goal of saving money today which will end up costing more tomorrow.

 

 

Prof. Christos Lionis, Director, Clinical Social and Family Medicine, faculty of Medicine & the University Hospital of Heraklion (Crete) spoke of primary health care in Greece, a highly controversial issue in the country since the government is in the process of introducing reforms in this field too. He presented the data collected at the first primary care unit in the city of Heraklion run by the University. This unit has been providing healthcare services to people with no insurance, low income as well as migrants. He analyzed the profiles of patients visiting the unit concluding that most of them are uninsured for over two years, they do not take their medicines as they are supposed to either because their medicines are not available or they cannot afford them. He emphasized that medical schools curricula need to change, become socially accountable and to engage patients and other stakeholders.

 

 

Giorgos Zarkotos, President, Greek Association of Drugs and Substitutes Users commented that the crisis has deteriorated the problems that many marginalized social groups are faced with such as prostitutes, substitute uses, prisoners, roma people, homeless, immigrants. He stated that most of them apart from the social stigma have no access to health services. Moreover, state funding into harm reduction programmes has been dramatically reduced. This has resulted in deteriorating health situations such as a considerable increase in HIV cases in the country among drug users. Syringes distribution has fallen to almost zero levels leading to this increase in HIV and Hepatitis C cases. He emphasized that most Hepatitis C patients belonging to these social groups receive no treatment. He called upon the Greek government to: a) support more needle and syringes programmes, b) strengthen HIV testing and counseling, c) provide comprehensive and sustainable ART treatment, d) focus on vaccination, diagnosis and treatment of viral hepatitis and e) reinforce prevention, diagnosis and treatment of tuberculosis.

 

 

Liana Mailli, President, Médecins du Monde Greece presented valuable data from the MdM’s activities on the ground. She said that more and more people visit the clinics & medical centres run by MdM Greece in order to receive not only health services but also food and clothing. During the first nine months of 2013, more than 13.000 people have used the mobile medical units of MdM Greece. She emphasized that there is a 20% annual increase in the number of people using the various services of MdM Greece. Vaccines constitute the number one type of medicine that people who turn to MdM Greece ask for which demonstrates that children are also very much affected by the austerity crisis. In the first nine months of 2013, around 7.000 children were vaccinated. She added that more than 2.500 people visit the main MdM clinic in Athens on a monthly basis. Most people using MdM services are Greeks who have fallen off the social safety net. This means that these people and their families do not have access to any health services anymore.

 

 

Policy-making session II: Benchmarks ahead moderated by Tassos Telloglou, Reporter, Kathimerini newspaper & Star Channel

 

 

Rohit Malpani, Director, Policy and advocacy, Doctors Without Borders’ Access Campaign explained that patent monopolies lead to extreme prices for life-saving treatments. He gave the example of the recently approved Hepatitis Cdrug which will be sold at 60.000 euro for a 12-week course even though the cost of manufacturing it ranges between 50-100 euro. He criticized the view that tiered-pricing is the way forward stating that price reductions are not always sufficient, it is usually implemented in an arbitrary manner and all of the above; usually unfold in complete lack of transparency. In relation to the issue of patents, he stated that these should only be granted for true innovations and ever-greening should be avoided. In this respect, he mentioned that a generic equivalent of the famous cancer drug Herceptin was recently approved in India. He stressed that most innovation stems from publicly-funded research which should not be given as a present to pharmaceutical industries. In addition to the above, he criticized the European Commission for exercising pressure on developing countries that employ compulsory licensing and other safeguards to ensure affordable treatment. In his view, the European Commission should refrain from supporting tiered pricing as the solution to access. Moreover, he expressed the view that free trade agreements should not limit the ability of EU Member States to use public health safeguards. Last but not least, he reminded everyone that anti-competitive intellectual property strategies cost EU consumers 2 billion Euros between 2000 and 2007.

 

 

Dr. Christos Ntellos, Director, Cardiac surgical dept. Tzanio public hospital (Pireaus) stated that doctors overprescribe medicines in Greece. He stressed that innovative medicines which are highly promoted by the pharmaceutical industry are not truly innovative while they cost a fortune for the national health budget. He criticized the role of doctors in joining those glorifying innovative medicines even though they know very well that there is no substantial difference. To this end, he gave the example of medicines against cholesterol which are profusely prescribed even though it is clear that exercise is much more effective in the fight against cholesterol. This is why; there is still a lot of space for corruption. He called on doctors to stop playing with patients’ sense of agony and hope when it comes to generics and new innovative medicines. In his view, reliable generics are the way forward. He commented that people need to realize that expensive medicines do not necessarily equal better treatments. He concluded by pointing out the following: a) patients’ real needs in medicines are much smaller than the medicines prescribed and consumed today, b) there need to be strict therapeutic protocols in place, c) priority should be given to the use of generics and d) older and cheaper medicines should not be sidelined.

 

Prof. Nikos Maniadakis, Associate Dean, National School of Public Health (ESDY) author the latest pricing law on medicines gave an in-depth presentation of the piece of legislation. He analyzed the spectrum of measures implemented by the Greek government in relation to medicines in Greece (new lists of medicines, strict budget thresholds, new pricing scheme, e-prescription, generics, guidelines and therapeutic protocols). In terms of patent medicines, their price will be defined according to the three lowest prices in EU member states. As regards, off patent medicines, their price will be halved following the expiry of the patent. As for generics, their price will be further reduced and will be determined at 65% of the off patent medicine with a similar active ingredient. He added that the law anticipates the possibility for some dynamic pricing i.e. the higher the sales of a generic medicine are, the cheaper they can get. Editor’s note: This is considered by Greek pharma as the most threatening provision. In their view, dynamic pricing is the Ministry’s present to foreign pharma as it will enable the latter to lower their generics’ prices tremendously and consequently wipe Greek companies off the map.

 

 

Giulia Del Brenna, Adviser, Task Force for Greece, European Commission thanked the NGO community for providing data on the real situation in Greece while she criticized the Greek Government for not giving any reliable data on health coverage and access to medicines. Sheexplained that the work of the Task Force is to ensure universal health coverage through a social safety net with the use of clinical guidelines and protocols. She stressed that what is needed in Greece is transparency. She highlighted the importance of primary health care reform. She reiterated that it is up to the Greek government to decide which measures to implement in putting the reforms in place. She acknowledged that “in an ideal world” there should have been impact assessment studies of the reforms put forth. E-Health constitutes one of the main focal points of the technical assistance when it comes to hospital management.

 

 

Charalambos Karathanos, Pharmacist, Advisor to the Minister of Health on medicines issues clearly stated that the 2bn euro target for 2014 is neither feasible nor realistic. He repeated the government’s position that 2.5 bn euro will be needed for 2014 and reiterated that the final figure is still under negotiation with the Troika. He reaffirmed the government’s determination to encourage the use of generics in the Greek NHS and criticized those who question the safety and quality of generics. He reminded everyone that most generics used in Greece come from Greek pharmaceuticals that produce excellent quality products. On the issue of the uninsured people living in Greece, he stated that the government is seeking to find solutions. Last but not least, he referred to the presentation of Oliver Moldenhauer (TACD event in Athens, 31 May 2013) regarding the prospect of using WTO provisions and flexibilities in order to allow for cheaper medicines to enter the Greek market.

 

 

The Q&A session that followed was dominated by questions addressed to the TFGR representative and the Minister’s advisor. Discussion was very much heated between the Minister’s advisor and patients’ representatives.

 

 

 

 

 

Civil society empowerment workshop/advocacy capacity-building

 

(about 40 patient representatives coming from all over Greece)

 

Session 1: Towards an effective patients’ movement in Greece

 

 

Alex Wyke, Patient View, founder and Managing Director explained the reasons why policy-makers need to listen to patient groups: a) Health costs are governed by the demands that patients place on the national healthcare system, b) Such systems need to spend wisely—but also to understand patients (and thereby not waste resources on unnecessary services) and c) Patient groups understand patients. They can support patient empowerment, and help make the best use of resources outside healthcare systems. She added that patients can play a crucial role in the following areas: a) influencing the doctors’ environment, b) lobbying for budget, c) helping to set prescribing guidelines, d) shaping government priorities and e) defining professional accountability. There are numerous sources of information for patients; all they have to do is know where to look. In addressing the Greek patients associations, she emphasized that fragmentation is their biggest challenge and enemy. Policymakers have little time, and do not want to speak to hundreds of patient groups. They also believe that disease-oriented patient groups have vested interests, and are prejudiced. Last but not least, fragmented patient groups are not as effective as networked patient groups that present a unified image. She gave the example of cancer patients where PatientView has identified 50 different types of patient groups which tend to act independently of one another. Nevertheless, she commented that an ever-closer integration process is unravelling while cross-stake holder coalitions are now increasingly happening.

 

 

Kathi Apostolidis, President, DE.DI.DI.KA. & Vice-president, European Cancer Patients Coalition (ECPC) guided the audience through the social media world and its use today. In her view, patient groups need to take advantage of the potential that social media has to offer. She stressed that efficient social media use requires commitment, time and money as it usually takes a staff member working exclusively on setting up and most importantly, sustaining in the long term an organization’s social media platforms. These means can be used among others to raise public awareness, attract attention and publicity, raise funds and recruit new members. For example, social media platforms could be employed to recruit some additional volunteers in light of an event that the organization is planning to host or to build new relationships with influential figures who can act as multipliers for the organisation’s messages. She mentioned the following rules regarding the use of social media: 1) Listen. Social Media is not about you. It is about people’s relationships with you. Listen before you speak. 2) Get involved. Social Media is about conversations and building relationships. It takes effort. 3) Don’t just talk about yourself. Ask questions, engage people and link. Most of all be inspiring. 4) Give up control. You cannot control the conversation. If you want people to spread your message, you have to trust them. 5) Be honest. You can’t spin the truth with Social Media. Be open, honest and authentic in everything you say and do.

 

 

Following the two presentations, patient representatives were split into two working groups of about 15 people and were called upon to brainstorm on one question each. Working Group A was instructed by Alex Wyke to present the main priorities of the patients’ movement in Greece while Kathi Apostolidis instructed Working Group B to work on a social media strategy for their respective organisations.

 

 

Debate in Working Group A was rather heated as participants found it difficult a) to comprehend what was asked of them, b) to think beyond the narrow limits of their own organization and c) agree on common priorities of mutual concern and interest. Nevertheless, they listed the following as overarching priorities for all patients in Greece:

 

 

  1. Universal public health coverage in Greece with special attention to chronic diseases

  2. Access to health services irrespective of one’s employment status for everyone living in the country

  3. Patient empowerment

  4. Training of patients so as to be able to better participate and engage

  5. Raising public awareness – prevention – diagnostics

  6. Transparency at all levels when it comes to medicines a) safety & quality (cost-benefit analysis & efficacy) and b) affordability (both for the patient as well as the state budget)

  7. Affordable medicines & treatments

  8. Right to work for handicapped people & people with chronic diseases

 

 

Session 2: “Weapons” of the patients’ movement in times of crisis

 

 

Gaelle Krikorian, Adviser on Intellectual Property & Access to Knowledge-Greens/EFA, European Parliament spoke about the special features of the following semester for Greece having the EU presidency in combination with the European elections in May. She expressed the view that people have a say in EU affairs through parliamentary questions, questions addressed to the European Commission, the citizens’ initiative as well as the Troika enquiry. Therefore, she called on participants to elect good parliamentarians next May. She then commented that expensive medicines can be dealt with through good quality generics which nevertheless, do not solve the issue of patent monopolies and outrageous medicines’ prices. She explained that it is a very sensitive subject which when implemented causes a series of retaliations from both governments and the pharmaceutical industry. She nonetheless explained that it is a goal worth pursuing as Thailand did. Thailand took the political decision to issue a compulsory-license on heart, HIV and cancer medicines. Strong social mobilization on behalf of patient groups, NGOs working on public health, academics and other civil society stakeholders rallied behind the Thai government’s decision. Workshop participants were encouraged to examine compulsory-licensing in the case of Greece.

 

 

Maria Moudatsou, Forensic Psychologist, Director of Institutional & Vertical Fundraising, NGO PRAKSIS guided patient groups through the process of fundraising. She explained everything ranging from where to look for grants and funding opportunities, how to approach sponsoring entities such as foundations, organizations and others, how to present an organization, how to apply for a grant etc. She emphasized the need for synergies and forging alliances with other stakeholders. Strategic planning & management constitute another pillar for the organization of a patient group.

 

 

Dimitris Kremalis, Partner, Kremalis Law Firm & President, Greek Health Law Association provided a brief overview of the legal framework for patients in times of crisis.