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).
New leaked Merck missive reveals deep drug, medical device company opposition to South African patent reforms
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.
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
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: firstname.lastname@example.org
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
KEI testimony on WIPO broadcasting treaty, to House Judiciary Subcommittee on Courts, Intellectual Property, and Internet
Testimony of James Packard Love
Hearing on: The Scope of Copyright Protection
January 14, 2014
Subcommittee on Courts, Intellectual Property, and the Internet
My 10 page written statement is here: http://keionline.org/sites/default/files/JamesLove_Testimony.pdf
My 5 minute oral statement follows:
James Packard Love, Opening statement
Hearing on: The Scope of Copyright Protection
January 14, 2014
Subcommittee on Courts, Intellectual Property, and the Internet
Timeline of WIPO negotiations on a Treaty for the Protection of Broadcasting Organizations
- Done at Rome on 26 October 1961 in Rome, Rome Convention for the Protection of Performers, Producers of Phonograms and Broadcasting Organizations
WIPO hosts Conference on Open Innovation: Collaborative Projects and the Future of Knowledge (22-23 January 2014)
The World Intellectual Property Organization (WIPO) will host a "Conference on Open Innovation: Collaborative Projects and the Future of Knowledge" on 22-23 January 2014 at its headquarters in Geneva, Switzerland.
The origins of this conference on open collaborative development models is predicated upon Recommendation 36 of the WIPO Development Agenda which states:
Today Senators Bacus and Hatch introduced fast track legislation in the Senate. The words transparent or transparency appear 17 times in the 107 page bill, but only twice in connection with "Trade Institution Transparency."
European Parliament office in Athens, 13 December 2013
Event summary report
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)
Synopsis of presentations’ main points
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:
Universal public health coverage in Greece with special attention to chronic diseases
Access to health services irrespective of one’s employment status for everyone living in the country
Training of patients so as to be able to better participate and engage
Raising public awareness – prevention – diagnostics
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)
Affordable medicines & treatments
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.
LESI to convene Global Technology Impact Forum (20-21 January 2014) at WIPO followed by dinner at the Mandarin Oriental
The Licensing Executives Society International, Inc. (LESI) is convening its annual Global Technology Impact Forum (GTIF) at the headquarters of the World Intellectual Property Organization (WIPO) from 20 to 21 January 2014 in Geneva, Switzerland. Although this international forum is hosted in Room A at WIPO headquarters, this event (at the time of publication of this blog) does not appear on the calendar of WIPO events for January 2014.
No change in EU law is needed for implementation of right to read Marrakech Treaty
European Commission corrects course on Treaty ratification
The Marrakech Treaty, agreed upon last June, means applying a global exception to copyright to enable access to reading materials for millions of blind and visually impaired persons. It would allow the cross-border shipment of formatted works for a deprived population that aims to overcome its “book famine”. The EU first needs to sign the treaty, then it needs to be ratified and, finally, it needs to be implemented into the laws of the 28 EU member states. This whole process could be undertaken in 2014.
At an event at the European Parliament on December 18th organized by the European Blind Union and TACD Pierre Delsaux, Deputy Director General for DG Market of the European Commission stated that no changes in EU legislation was needed for the ratification and implementation of the Treaty into EU and EU member state laws. This statement is in stark contradiction with the position taken by DG Market Head of Unit for Copyright Maria Martín Prat who stated before the European Parliament´s Legal Affairs Committee in November that implementation of the Treaty would have to wait for new EU Copyright legislation that is now under consultation (a process that would take up to 3 or 4 years). On the contrary, Prat´s superior Delsaux said that the Marrakech Treaty should “not be mixed up with the general debate about the future of copyright in the EU”. Pierre Delsaux also rejected the idea put forth by some member states that a cumbersome and complicated EU centralized register was needed for all works to be covered under the copyright exception of the Marrakech Treaty.
Dozens of blind persons from around Europe have lobbied the European Institutions demanding a swift ratification of the Marrakech Treaty by the European Union. Leaders of major visually impaired organizations spoke at the European Parliament conference sponsored by MEPs Luigi Berlinguer, Eva Lichtenberger and Francisco Sosa Wagner. Speakers at the event included Rodolfo Cattani from Italy, vice-chair of the European Disability Forum, Barbara Martín, head of European relations for the Organización Nacional de Ciegos of Spain, Wolfgang Angerman from Germany in representation of the European Blind Union and other representatives from Austria and France.
All those present pledged to continue campaigning until the Marrakech Treaty is fully implemented in the European Union and effective globally.
USPTO 2013 utility patent grants (notes on country of assignment, invention class, government rights in patents)
In 2013, the USPTO issued 277,861 utility patents, a new record in terms of the numbers of patent grants, and an increase of 9.8 percent over 2012.*
Country of Assignment
Of the total, 126,574 (45.6 percent) were assigned to a US owner, a small increase in the percent held by US entities over 2012.
Below is the final version of the conclusions from SCCR 26 (followed at the end with a short KEI commentary).------------
World Intellectual Property Organization (WIPO)
Standing Committee on Copyright and Related Rights (SCCR)
Geneva, December 20, 2013
Protection of Broadcasting Organizations
Proposed conclusions to SCCR 26
See PDF. Note that PDF has pages 2&3 out of order http://keionline.org/node/1874
Conclusions at a glance:
Item #1 At SCCR 26, Broadcasting Treaty: the proposed treaty is moving forward toward a diplomatic conference in 2015. It includes transmission over the internet. Paragraphs 1 to 10.
See PDF attachment. Note that PDF has pages 2 and 3 out of order.
SCCR 26 December 20, 2013 afternoon: workplan discussion
After 5 days of diplomatic if not collegial meetings (at least in plenary, I do not really know what is going on in informals), the last day afternoon session is quite tense. The conclusions have been drafted (I briefly saw a leaked version) and the group coordinators have met with the Chair.
KEI Statement at WIPO SCCR 26 on Limitations and Exceptions for education, research & persons with other disabilities (12/20/13)
[as delivered orally this morning]
Thank you, Mr. Chairman.
Discussions regarding an "International legal instrument in whatever form on limitations and exceptions for educational teaching and research institutions and persons with other disabilities" 12/20/13
Friday December 20, 2013 10am to 1pm