On September 8, 2014, Vice President Joe Biden wrote to Juan Manuel Santos Calderón, the President of Colombia. In the letter, Biden registered a complaint about the regulations in Colombia to register biosimilar drugs. A copy of the letter from Vice President Joe Biden is available here, and includes this quote:
European Parliament Strasbourg Plenary Session
Subject: Commission statement – Access to life-saving medicines in Europe
Date: September 16 2014
Connie Hedegaard, European Commissioner for Climate Action said that the Commission shared the concerns regarding the affordability of new medical products and the related risk of inequalities. She added that the Commission Communication in April 2014 on resilient health systems focuses on increasing accessibility to health services. At the June health ministers’ Council, France raised the issue of the new Hepatitis C treatment. Member states will discuss pricing and reimbursement in the coming months. This new treatment is not an isolated case. Therefore, the Commission is looking forward to the debate on the therapeutic innovation at next week’s health ministers’ Council. As regards, support to medical innovation, the Commission believes in the contribution of the Innovative Medicines Initiative (IMI). She commented that the European pharmaceutical legislation includes a wide spectrum of measures to guarantee access to necessary medicines. The Commission has however no competence to regulate the level of prices. Thus there can be no price caps but it can nonetheless help with the exchange of information between member states. She concluded by saying that another way in which the European Commission could assist member states is through the use of the joint procurement mechanism.
Miroslav Mikolasik (EPP, SK) stated that this is an important topic for patients and saving lives. He emphasized the fact that the situation is not the same across all member states. He added that the high prices of medicines reflect the research that led to their development. Nevertheless, ppharmaceutical companies should not misuse nor abuse their unique position. In the period 2000-2009, public spending for medicines has increased by 76% and this is unprecedented. The EU population is ageing and the prices of new medicines are constantly increasing.
Biljana Borzan (S&D, HR) said that medical progress leads to efficient but expensive medicines. Millions of euros are used to save banks in Europe today while Europeans lack access to necessary medicines. Public funds should be used to promote medical research and development. She called for shorter patents because prices go down when patents expire.
Beatrix Von Storch (ECR, DE) stated that on the 18th of October 2011 the European Court of Justice made that human life begins at the stage when the semen touches the egg. She therefore criticized stem cell research. The European Commission should discourage stem cell research because this equals destruction of human life.
Beatriz Becerra Basterrechea (ALDE, ES) said that Hepatitis C is an infectious disease that constitutes a public health crisis. She favoured the issuing of a compulsory license that will enable the manufacturing of a generic. The EU should challenge the patent legally. She added that the option of joint public procurement should be examined. Egypt imports the generic equivalent of the new Hepatitis C treatment at a price 100 times lower. Another 90 developing countries will benefit from India’s decision to produce generic equivalents. In her view, the Commission should defend the general interest of European citizens. She gave the example of price caps for roaming and wondered what is more important public health or a matter like roaming costs.
Kostas Chrysogonos (GUE/NGL, EL) said that pharmaceutical companies push for ever higher prices through their monopolies. High prices are not the only obstacle to people’s access to life-saving medicines. In reality, the competent bodies inside the EU are not only indifferent towards these prices but also impose spending cuts on health services. The worst situation is faced by those countries under memoranda where the Troika demands continuously cuts in public health expenditure.
Michele Rivasi (Greens/EFA, FR) stated that the new treatment against Hepatitis C affects millions of Europeans. It therefore becomes a real public health question. She called for compulsory licenses against long patents and monopolies. She explained that compulsory licenses will open the markets. There is also the question of medical research. In this respect, the current Western African Ebola crisis is due to the fact that no pharmaceutical company has invested in developing a vaccine because it would not be profitable. In other words, public health becomes a market-driven policy.
Dario Tamburrano (EFD, IT) welcomed the debate. He criticized the fact that DG Industry will be responsible for health matters in the new Commission.
Eva Kaili (S&D, EL) argued that human rights are more important than intellectual property rights. She called for more transparency in order to know what is happening with medical innovation inside big pharmaceutical companies. She called for shorter patents. In her view, the EU should act against these ridiculous prices of medicines. Moreover, she favoured the use of generics.
Branislav Skripek (ECR, SK) said that medicines should be available to all and not only to the privileged ones. He defended people’s access to health care services.
Marian Harkin (ALDE, IE) said that countries undergoing austerity programs are faced with the most serious challenges. The Commission admits that these cuts in health expenditure affect the most vulnerable parts of the society. She called on European Commission president Junker to revisit his decision about assigning health issues such as pharmaceutical products to DG Enterprise and Industry.
Marisa Matias (GUE/NGL, PT) said that these prices are scandalous especially for countries forced to cut their public health budget. She argued that this is shameful profiteering on behalf of big pharmaceutical companies and has nothing to do with funding innovative research. The European Commission might not be able to do much about prices but it can certainly put an end to patent monopolies, if there is political will.
Margrete Auken (Greens/EFA, DK) said that the greed of the pharmaceutical industry is unlimited. Even though, it is a fact that most of medical innovation comes from publicly funded research, industry is allowed to profit from European taxpayers’ money. She added that moving the pharmaceutical industry dossier to DG Enterprise is a cynical idea. Human lives should not be sacrificed for more money.
Giorgos Grammatikakis (S&D, EL) stated that over the past few years, there has been a serious access to medicines crisis in Greece. He explained that many pharmaceutical companies blackmailed the country with shortages and stock-outs. He stressed that small countries like Greece cannot stand up against the big pharmaceutical interests and thus called for increased European cooperation on this matter.
Angela Vallina (GUE/NGL, ES) called for better checks of pharmaceutical companies in the EU. She called for lower prices of medicines. The EU should not be a silent witness when people are dying despite the fact that there is a treatment.
Soledad Cabezon Ruiz (S&D, ES) said that the EU should investigate the profits of pharmaceutical companies. Everyone in Europe should have access to life-saving treatments. She also called for a review of intellectual property rights when it comes to medical innovation and research.
Catch the eye procedure
Joao Ferreira (GUE/NGL, PT) criticized the Commission for not doing more than just talking. He said that the European Commission is part of the Troika which imposes the strictest public health spending cuts.
Connie Hedegaard, European Commissioner for Climate Action reminded that the European Commission has no competence over pricing of medicines. She nevertheless stressed that the Commission can do other things such as promote the exchange of information between member states. She added that it is up to member states to take these matters forward and expressed her certainty that the informal health ministers’ council will have this item on its agenda at their next meeting.
Dear Mr. President-elect,
We are writing to express our astonishment and concern regarding your decision to move the competence for medicinal products and health technologies from the Commissioner in charge of Health to the Commissioner in charge of internal market and industry within the new Commission.
The economic crisis, the ageing of the population, technological advances, and new health threats, including environmental pollution, are all challenging the sustainability of European health systems, and health inequalities between and within European Union (EU) Member States are increasing.
The European Commission, as the guardian of the Treaty, plays an important role in “ensur[ing] a high level of human health protection”. This necessitates an unwavering vision for public health, along with consistent and coherent policymaking to support it.
People living in Europe have the right to high quality, safe, affordable and effective treatments. Pharmaceuticals and medical devices are not – and should not – be considered as any other internal market product because they safeguard people’s health.
The main driver of EU policies concerning pharmaceuticals and health technologies should be promoting and protecting health and patient safety. The Commissioner for Industry and Internal market, however, is mandated to promote the competitiveness of the industry and the European economy. This distinction is an important one to make with delicate issues, such as information to patients and medicine pricing, where the needs of patients can be in conflict with the interests of industry. The shift you are proposing sends the wrong signal to European citizens and patients – namely that economic interests come before their health. This is not the sort of signal the EU wants to send.
In 2009, responsibility for medicines and medical devices were moved into the hands of the health Commissioner to harmonize pharmaceutical governance within Member States and facilitate emergency preparedness. Returning them to the Commissioner for Enterprise and Industry is unjustified and represents a major step back.
Please reconsider this decision – we believe that medicinal products and health technology belong under the responsibility of the Commissioner for health.
We urge you to show bold leadership and to put health interests first.
Press contact: email@example.com
A long standing parlor game for WIPO insiders and observers during the summer of 2014 involved guessing the composition of WIPO's new Senior Management Team (the team of deputy director generals and assistant director generals who form WIPO's cabinet). On 16 September 2014, the WIPO secretariat laid this to rest by revealing the composition of the new WIPO Senior Management Team of deputy director generals and assistant director generals. New faces in the cabinet include: Mr.
On Monday, September 15, 2014, Gilead announced licensing agreements with 7 generic drug manufacturers, for two of its HCV drugs, including sofosbuvir, which is currently the most important HCV drug, and the basis for Gilead’s value to shareholders. KEI's statement from Monday, and links to other NGO comments are here: http://www.keionline.org/node/2082.
KEI welcomes the Gilead HCV licenses, as a step to expand access to treatments. Notes challenges that remain
Today Gilead announced it will provide seven generic drug manufacturers licenses to make and sell two drugs that are used in combination to treat the Hepatitis C Virus (HCV) in 91 developing countries.
Oral Question posed by French MEP Michelle Rivasi (Greens)
Access to medicines has repeatedly made the headlines in many EU countries over the past 3 months (in France, the UK, Spain, Greece, etc.). The reason for that is the price charged for Sofosbuvir, a drug that can cure hepatitis C. It is sold by the pharmaceutical firm Gilead, which charges generally between 50 000 and 60 000 euros per patient for a 12 weeks course in the Eurozone.
The situation with Sofosbuvir is urgent, but unfortunately it is not an isolated case. This level of prices not only is a new trend but it is becoming a new norm for serious diseases. As a consequence, we, for example, see how it is becoming harder and harder to ensure access to drugs to cancer patients in Europe. It is happening with Kadcyla® a drug for breast cancer, for Nexavar® a drug for kidney and liver cancer. And we are all affected, or soon will be.
The less innovation the pharmaceutical industry brings to the market, the more it prices the new drugs. Abuses of monopoly rights and patents is harming innovation and crushing health systems. We are seeing doctors and medical authorities forced to compromise their professional code of ethics and to invent false reasons of cost-effectiveness to justify sentencing people to death.Nothing in the chain of development of these drugs justifies these prices.
Rationing of life saving medicines in Europe is not acceptable. It is high time to reform a system that is increasingly dysfunctional, and to honestly address the issue of the research and development model we need for medical innovation.
Today 10 to 15% maximum of the price of a medicine will go towards research. Is that really the most effective way to proceed? Instead of paying 100 euros to endure that 10-15 euros will go to research, citizens, communities or States could pay directly the same share for research without having to bear the cost of monopoly.
France raised the issue of Sofosbuvir at the Council and before the Commission during the Summer. What are the Council and the Commission planning on doing to break this deadlock which is becoming deadly for an increasing number of EU citizens? When will we seriously discuss options that do not necessarily please a handful of multinationals but would serve the EU public interest, such as funding mechanisms and financial incentives that are not tied to the granting of exclusive rights and monopolies? When will we impose price caps on medicines the same way we were able to do for roaming?
In 2012, as a member of the Senate Finance Committee, Senator Ron Wyden was a strong advocate for providing the public with access to the TPP negotiating text. Now, as Chairman, the Senator has been silent on the public's right to the text. This is an example of Wyden in 2012. Has his position changed?
Timestamp and notes on Wyden comments on need for transparency in TPP
WIPO General Assembly 2014: Hard Decisions on the Broadcast Treaty and work program on copyright limitations and exceptions
In the piece, WIPO General Assembly 2014: Hard Decisions on the Design Law Treaty and Treaty for Protection of Genetic Resources (22 July 2014), KEI highlighted the hard decisions awaiting the WIPO General Assembly (22 September 2014 to 30 September 2014) with respect to the Design Law Treaty, the imminent revision of the Lisbon Agreement to include geographical indications and WIPO's work to conclude an instrument for the protection of genetic resources, traditional knowledge and folklore.
13 May 2014: WHO Technical Consultation on Innovative Models for New Antibiotics’ Development and Preservation
In a concerted bid to contain the emerging threat posed by antibiotic resistance, in May 2014, the World Health Organization's (WHO) 67th World Health Assembly (WHA) passed WHA resolution 67.25 on "Antimicrobial resistance" instructing the WHO to "develop a global action plan to combat antimicrobial resistance" by May 2015 (Source: WHO page on Draft Global action plan on antimicrobial resistance).
In May 2014, the World Health Organization's (WHO) 67th World Health Assembly (WHA67) passed decision WHA67(15) setting the stage for the creation of a new pooled funding mechanism for R&D.
OMB's Revised Guidance on Appointment of Lobbyists to Federal Advisory Committees, Boards, and Commissions
Following litigation by several lobbyists, OMB is revising its guidance on the appointment of lobbyists to federal advisory committees, boards, and commissions. Now, lobbyists can serve on these committees, including the USTR advisory boards. Money quote:
This is a note on Gilead run or funded programs that are available for patients residing in the United States.
Recently, Gilead's new hepatitis C drug, Sovaldi, has received much attention and criticism for its high price of $1000 a day.
Attached are two annexes from our 2014 USTR Special 301 comments
January 2013: Proposal for the inclusion of trastuzumab in WHO EML for treatment of HER2-Positive Breast Cancer
On 14 January 2013, Knowledge Ecology International (KEI), the University of California (San Francisco), Universities Allied for Essential Medicines (UAEM), and the Third World Network (TWN) submitted a Proposal for the Inclusion of Trastuzumab in the WHO Model List of Essential Medicines for the Treatment of HER2-Positive Breast Cancer to WHO's Expert Committee on the Selection and Use of Essentia
Money speaks: USTR releases letters from Congress backing PhRMA on exclusive rights biologic test data in TPP
As part of a partial response to FOIA request, USTR has provided KEI with copies of 13 letters sent by members of Congress, from July 27, 2011 to August 8, 2013, on the topic of biologic drug test data provisions in the TPP negotiation. We had obtained several but not all of these letters earlier from a variety of sources, including from PhRMA's web page -- where some had been proudly displayed. (See link below).
Were there letters on the other side? Yes, three. (see below).
With the FOIA request, we have also obtained the responses to the letters.
On July 24, 2014, the Medicines Patent Pool announced welcome modifications and expansions of their licensing agreement with Gilead. Among the significant changes were the addition of a new drug, tenofovir alafenamide (TAF), formerly known as GS-7340. TAF is a nucleotide reverse transcriptase inhibitor, and a prodrug of tenofovir. TAF is considered to have similar antiretroviral efficacy to tenofovir disoproxil fumarate (TDF), the drug it may replace in use, but can be administered with smaller doses and with less adverse effect on kidneys and bones.
KEI is creating a timeline for various events relating to the discovery and the development of diagnostics, vaccines and drugs for Hepatitis. A working draft of the timeline is available here.
WIPO General Assembly 2014: Hard Decisions on the Design Law Treaty and Treaty for Protection of Genetic Resources
The Assemblies of the Member States of the World Intellectual Property Organization (WIPO) convenes its Fifty-Fourth Series of meetings in Geneva from 22 September 2014 to 30 September 2014. These Assemblies include, inter alia, meetings of the WIPO General Assembly, the WIPO Coordination Committee, the Paris Union Assembly, the Berne Union Assembly, the Madrid Union Assembly, the Lisbon Union Assembly, the Patent Cooperation Treaty Assembly, the WIPO Copyright Treaty (WCT) Assembly and the WIPO Performances and Phonograms Treaty (WPPT) Assembly.
To get a quick look at who is holding patents on the Hepatitis C Virus, I did some searches of the USPTO database. In each search, I looked for the term HCV in the field for patent claims (ACLM). Note this is fairly arbitrary, and I get different (and higher) numbers if I include HCV in the Abstract. In any case:
There were 1164 patents that have the term HCV in the patent claim.