On Wednesday morning, 29 June 2016, Nigeria, on behalf of the African Group, presented a revised proposal (SCP/24/4) for a WIPO work program on Patents and Health at the Standing Committee on the Law of Patents (SCP). The African Group proposal is a welcome breath of fresh air in the patent committee; the proposal aims to make WIPO more responsive to recent developments including: 1) "Challenges to public health ....
29 June 2016
World Intellectual Property Organization (WIPO)
Standing Committee on the Law of Patents (24th session)
Statement of Knowledge Ecology International: Patents and Health
Briefing Call on National Institutes of Health (NIH) patent policies, 29 June 2016, 11:00 A.M. (EST)
KEI will host a conference call at 11:00 A.M. today to brief interested stakeholders and the press on issues related to NIH patent policy, including the recent decision in KEI's Xtandi petition (additional background here: http://keionline.org/xtandi), the grant of exclusive licenses on government-owned inventions (http://keionline.org/nih-licenses), and transparency of decision-making at NIH more broadly.
For call-in information, please contact Zack Struver at email@example.com.
27 June 2016
KEI statement on exceptions and limitations to patent rights
In relation to limitations and exceptions, we recall Brazil’s prescient submission, document SCP/14/7 (tabled in January 2010) which called attention to the lack of policy coherence in a world where in certain international fora, countries endorse the use of compulsory licensing to promote access to medicines for all, and in separate fora, criticize developing countries for actually considering or issuing such compulsory licenses.
In the wake of the NIH's letter to KEI declining to use the government's rights in the federally-funded patents on Xtandi under the Bayh Dole Act, it is interesting to consider that even the Gates Foundation, hardly the anti-patent group, maintains certain programs and policies to ensure that Gates-funded inventions are used for charitable purposes, with limitations on pricing.
Dr. S. Ward Casscells took the stage at the 2011 Innovative Minds in Prostate Cancer Today (IMPaCT) Meeting as a prostate cancer patient, a doctor, an Army Reserve colonel, and the former top doctor for the Pentagon. There, he praised the central role of the Department of Defense in bringing important prostate cancer medicines to market, including Xtandi (referred to by its experimental name, MDV3100), an expensive prostate cancer drug that was funded from basic research through phase I and II clinical trials by taxpayer and charitable funds.
National Institutes of Health Declines to Exercise Authority to Lower Xtandi Price
The National Institutes of Health will not use its rights under the Bayh-Dole Act to end the monopoly on the expensive prostate cancer drug Xtandi and allow low-priced generic versions to compete on the market.
Human Rights Council heats up during informal talks on the primacy of human rights over international trade and IP regimes
At the 32nd session (13 June 2016 - 1 July 2016) of the Human Rights Council, a bloc of countries known as the the Core Group (Brazil, Egypt, Indonesia, India, Senegal, South Africa and Thailand) have tabled a resolution on access to medicines "premised on the primacy of human rights over international trade, investment and intellectual property regimes." The draft resolution complements the work of the United Nations High-Level Panel on Access to Medicines in reviewing and assessing “proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inven
Health Minister Alejandro Gaviria issued a declaration that it would be in the public interest for the government to lower the price of Novartis’ expensive leukemia drug, Gleevec (imatinib).
CONTACT: Andrew Goldman, +1 (202) 332-2670 or firstname.lastname@example.org
The following individuals are also available for comment:
- Andrea Carolina Reyes Rojas, Misión Salud: email@example.com
- Dr. Francisco Rossi, IFARMA: firstname.lastname@example.org
Washington, DC, June 17, 2016 — Colombian Minister of Health Alejandro Gaviria today issued Resolution 2475 of 2016, declaring that it would be in the public interest for the government of Colombia to lower the price of an expensive leukemia drug. The Ministry of Health describes this resolution as unprecedented in Colombia.
The drug, imatinib, is marketed as Glivec in Colombia by the Swiss pharmaceutical company Novartis at a price of approximately $15,000 per patient per year, nearly twice the average income of a Colombian resident. Glivec has generated over $47 billion in global revenue for Novartis.
More on this dispute at http://keionline.org/colombia
In response to the recent announcement from Colombia's Ministry of Health that a public interest declaration regarding imatinib will be issued in a matter of days, Novartis issued a statement that criticized the forthcoming action, saying, "We have consistently said that Declarations of Public Interest can be important and legitimate tools to be used only in exceptional circumstances," and saying "this is simply not the case in Colombia."
The US Chamber of Commerce might consider renaming itself the US/Swiss Chamber of Commerce, after their most recent attack on the Colombia Minister of Health (MoH) announcement that a "Declaration of Public Interest" would be issued for the patents on the cancer drug imatinib, held by the Swiss company Novartis. In the US Chamber's defense of the Swiss drug company, they don't mention the fact that Novartis has earned about $48 billion from sales of imatinib (sold by Novartis under the brand names Gleevec or Glivec) since the drug was put on the market, including more than $380 million per month in 2015.
Alfred Engelberg and Aaron Kesselheim in Nature on Bayh-Dole royalty free rights in patents, Xtandi case
Alfred Engelberg and Aaron Kesselheim have published an opinion article in Nature titled:
"Use the Bayh-Dole Act to lower drug prices for government healthcare programs," Nature Medicine 22, 576 (2016) doi:10.1038/nm0616-576, Published online 07 June 2016.
Colombia Ministry of Health Announces that Negotiations With Novartis Have Failed; Declaration of Public Interest Imminent
Reports have emerged from a DNDi meeting in Rio de Janeiro, Brazil, that the Colombian Ministry of Health announced that negotiations with Novartis over the price of Glivec have failed, and that Minister Alejandro Gaviria will proceed with the formal declaration that a compulsory license for the patents on the drug is in the public interest.
ADVANCED?MANUFACTURING COALITION FOR
TECHNOLOGY & INNOVATION /
ALLIANCE FOR CLEAN TECHNOLOGY INNOVATION
December 7, 2015
The Honorable Michael Froman
Office of the United States Trade
600 17th Street, NW
Washington, DC 20508
Fax: (202) 395-4549
The Honorable Penny Pritzker
United States Department of Commerce
1401 Constitution Ave., NW
Washington, DC 20230
Fax: (202) 482-2741
The Honorable John Kerry
United States Department of State
2201 C Street, NW
Washington, DC 20520
Fax: (202) 647-2283
Re: U.S. IPR and the COP21 Climate Negotiation
Dear Secretary Kerry, Ambassador Froman, and Secretary Pritzker:
As the COP21 UNFCCC meeting in Paris progresses, we ask for your continued
leadership in rejecting the ongoing demands of a small group of foreign governments and NGOs
that UNFCCC member governments weaken the protection of climate change-related patents and
other Intellectual Property Rights (IPR), or that they agree to measures or provisions that would
otherwise undermine existing global IPR standards. Any such outcome would not only
undermine previously agreed global IPR standards as reflected in the WTO Agreement on Trade-
Related Intellectual Property Rights (TRIPS) in particular, but would be counterproductive from
a perspective of addressing the effects and underlying causes of global climate change (for which
innovation and continued dissemination and deployment of clean technologies is needed), and
have serious negative consequences for U.S. industry, U.S. exports, and U.S. jobs.
Over the years, several countries and NGOs have sought to insert references to IPR in
UNFCCC decisions and other negotiating outcomes. This has ranged from overt schemes like
compulsory licensing, veiled references to “flexibilities” and “balancing” IPRs, to proposals to
create UN- or foreign government-led bodies to buy up and effectively redistribute American
and other IPRs and their related technologies.
We urge you to avoid all references to IPR, positive or negative, in the agreement or
decision text. This is particularly critical with respect to references that relate to IPR and
finance, which could be viewed as an institutional mechanism to engage in compulsory
There are several reasons why these and other IPR-related proposals are so harmful:
? First, U.S. firms are currently among the world’s leaders in the development and production
of cleaner, more efficient technology, goods, and services. Enhancing this leadership
position will help create and maintain high-paying jobs in America and sustain future U.S.
economic growth, exports, and trade. Failing to do so means losing the battle for
competitiveness and jobs to China, India, and other nations, all of whom are investing in
these key growth markets and have aggressive industrial policies in place that are targeted at
U.S. technology and U.S. innovation. Continued strong global IPR protection is key.
? Second, failure to protect clean technology IPR would also undermine the very climate
change action that the Administration (and the UNFCCC) is aiming to pursue. The evidence
shows, for example, that strong IPR protection encourages private sector investment in new
technologies and innovation, helps companies market and thus monetize their competitive
technological edge, yet at the same time rewards the sharing of knowledge and inventions,
rather than inhibiting or punishing it.1 A wide body of economic and policy literature also
confirms that IPRs help facilitate both the development of new clean technology solutions,
and their adoption and deployment on the ground.2 As such, patents and other forms of IPR
protection are a tried-and-tested tool to achieve global climate change-related objectives, as
well as sustainable development and investment in some of the world’s poorest and most
vulnerable nations. Indeed, in most developing countries it is not the existence of IPR
protection that is the problem, but rather its absence.
Finally, no matter how carefully crafted, failure to keep IPR issues out of a UNFCCC or
other UN climate change or sustainable development agreement or decision will result in
significant legal, institutional and practical confusion precisely because such IPR issues are
already well-regulated at the WTO and elsewhere. Even worse, any kind of compromise
language on or references to IPR in a climate change or other UN agreement or decision,
risks undermining this Administration’s own recent negotiating efforts in the Transpacific
Trade Partnership (TPP) Agreement and elsewhere, and would send mixed signals to our
negotiating partners around the world. It would send a confusing signal and be harmful not
just for the U.S. economy, innovation, exports, and jobs, but for the very climate changerelated
objectives that the UNFCCC COP21 negotiation is purporting to pursue.
1 See, e.g., PriceWaterhouseCoopers, Innovation: Government’s Many Roles in Fostering Innovation (2010).
2 See, e.g., Kristina M. Lybecker and Sebastian Lohse, WIPO Global Challenges Report, Innovation and Diffusion
of Green Technologies: The Role of Intellectual Property and Other Enabling Factors, WIPO: Geneva (2015); U.N.
Conference on Trade and Development, Foreign direct investment, the transfer and diffusion of technology, and
sustainable development (2011), available at http://unctad.org/en/docs/ciiem2d2_en.pdf.
As the COP21 enters its final stages, we urge you to continue standing up for American
jobs, American exports, and American innovative businesses and entrepreneurs and to continue
rejecting any and all references to IPR in a COP21 agreement or decision, including more
indirect references or openings for future discussions about IPR, such as those mentioned above
and previously discussed with your teams.
We recognize the evolving nature of these negotiations and urge you continue to support
an environment where IP rights facilitate technology development and dissemination. We will
continue to communicate with your representatives on the ground in Paris from State, USTR, and
Commerce as a follow up to this letter.
Alliance for Clean Technology Innovation
Biotechnology Industry Association
Business Council for Sustainable Energy
Corn Refiners Association
Information Technology Industry Council
National Association of Manufacturers
National Foreign Trade Council
Northeast Clean Energy Council
U.S. Chamber of Commerce
United States Council for International Business
CC: The Honorable Michelle Lee
United States Patent and Trademark Office
USPTO Madison Building
600 Dulany Street
Alexandria, VA 22314
Fax: (571) 273-8300
CC: Ms. Caroline Atkinson
The White House
1600 Pennsylvania Avenue, NW
Washington, DC 20006
Fax: (202) 456-2461
CC: The Honorable Stefan Selig
United States Department of Commerce
1401 Constitution Ave., NW
Washington, DC 20230
Fax: (202) 482-2741
Oral Statement at World Intellectual Property Organization copyright committee (sccr 31)
Millions of consumers in Europe and the United States represented by TACD are in favour of the role public libraries in providing access to knowledge, research and preservation.
Recently we have commemorated 800 years of the Magna Carta and the Charter of the Forest that safeguarded the use and access of the common good from unreasonable, private enclosure. It limited the power of the monarchy to exercise its complete power over its properties. Today we are facing many attempts to enclose the digital and cultural sphere to prevent access to what should be the immaterial knowledge commons. International instruments for exceptions and limitations could prevent this.
Preservation of our cultural heritage should be a global public good and a part of our global knowledge commons.
Archives provide researchers with copies, aid scientific endeavors and preserve our cultural legacy. To ignore that we are in a digital age that can reinforce and enrich common knowledge is neither rational nor morally acceptable. It is not an alternative to impose cumbersome and expensive licensing schemes.
The right to reproduction is also needed for supplying copies for use, repair, lending and sharing between libraries and for individuals. Why deny exceptions and create barriers to this public non-profit service that helps many and hurts no one? There is no empirical objective evidence of substantial “negative unintended consequences.” by library activities.
It is quite surprising that the European Union that has recently presented a proposal for a reform of its copyright laws, with clear proposals for exceptions and limitations for text and data mining, disabilities and other areas but at the same time it is not willing to extend these initiatives to the rest of the world.
EU´s new copyright proposal that has just been released to reform the existing 2001 Information Society Directive. It states:
“The EU exception authorizing libraries and other institutions to allow on-screen consultation of works for research and private study only applies to terminals on the libraries’ physical premises, which does not take into account today’s technological possibilities for remote consultation. Lastly, the EU exception on preservation activities by cultural heritage institutions also needs attention, notably because Member States often do not take digital formats into account when implementing the exception at national level.25 The Commission will take action to ensure that the EU framework on exceptions that is relevant for access to knowledge, education and research is effective in the digital age and across borders.
To allow public interest research organizations to carry out text and data mining of content they have lawful access to, with full legal certainty, for scientific research purposes;
? provide clarity on the scope of the EU exception for ‘illustration for teaching’, and its application to digital uses and to online learning;
? provide a clear space for preservation by cultural heritage institutions, reflecting the use of digital technologies for preservation and the needs of born-digital and digitized works;
? support remote consultation, in closed electronic networks, of works held in research and academic libraries and other relevant institutions, for research and private study; “
Why can´t the EU enter into a parallel discussion here at WIPO about similar exceptions and limitations could be enacted for the libraries of the world?
What is acceptable for the European Union needs to be extended to the rest of the world for universal access to culture, education and science.
European Parliament (room JAN 6Q2), 2 December 2015, 13:00-15:00
We would like to invite you to the conference “It is not healthy: Mending the broken medicines innovation model” under the auspices of MEPs Marian-Jean MARINESCU (EPP, RO), Nessa CHILDERS (S&D, IE), Fredrick FEDERLEY (ALDE, SE – tbc), Lola Sanchez CALDENTEY (GUE/NGL, ES) with the support of the TransAtlantic Consumer Dialogue (TACD), the European Public Health Alliance (EPHA), Médecins du Monde (MdM) International network, Universities Allied for Essential Medicines (UAEM Europe), Salud Por Derecho in collaboration with the European Parliament Working Group on innovation, access to medicines & poverty-related diseases.
Health is a fundamental universal right and access to medicines is part of it. The EU and its Member states are committed to universal and equitable access to healthcare. Nevertheless, millions of European patients suffer from the lack of affordability of many life-saving medicines across Europe. The debate will examine the status quo regarding access to medicines in Europe and explore policy recommendations for more affordable medicines. Possible solutions to be considered will be: price and data transparency, cost-therapeutic benefit assessment of medical products and greater generic competition. We shall also debate new biomedical R&D strategies that increase the social return of public investments and promote affordable health-driven innovation which “de-links” research costs from final medicine prices.
Programme (13:00-15:00, room JAN 6Q2)
Welcoming remarks by sponsoring MEP
What is the diagnosis for our medical innovation and medicines pricing ills?
Introduction by sponsoring MEP
Moderated by Yannis Natsis @ynatsis, advocacy advisor on access to medicines, TACD
- Xavier Prats Monné, Director-General, DG SANTE, European Commission (to be confirmed)
- Teresa Alves, International Policy Adviser, La Revue Prescrire
- Dr. Fernando Lamata, @LamataF, Consejería de Sanidad de la Comunidad de Madrid, Madrid, Spain – member of the EC’s Expert Panel Working Group on access to health care
- Dr. Antje Haas, Head of our pharmaceuticals department, GKV-Spitzenverband
What are some of the possible cures for our ailing and expensive pharmaceutical model?
Introduction by sponsoring MEP
- Rachel Kiddell-Monroe, @Access2Rachel Special Advisor to Universities Allied for Essential Medicines (UAEM) @UAEM
- Dr. Bernard Pécoul, Executive Director, Drugs for Neglected Diseases Initiative (DNDi) @DNDi
- Els Toreele, @ElsTorreele Director of the Open Society Public Health Program’s Access to Essential Medicines Initiative @osfHealth
Concluding remarks by sponsoring MEP
Please join the discussion on twitter using #unHealthy.
We would kindly ask you to register your attendance (please mention title & organisation represented) by sending an email to email@example.com by Wednesday 25 November 2015.
Should you require a badge to access the European Parliament, please do not forget to provide us with your full name, nationality, passport/ID number and date of birth. Badges will be handed out at the “Altiero Spinelli” entrance of the European Parliament on Rue Wiertz 60 as of noon on the day of the event (please look for respective desk/poster).
A light lunch will be served at the start of the hearing.
EUROPEAN COMMISSION EXPERT PANEL ON EFFECTIVE WAYS OF INVESTING IN HEALTH
Access to health
services in the European Union
approved this opinion for public consultation
by written procedure on 25 September, 2015
Public Consultation is open until November 8th, 2015
Expert Panel members
Margaret Barry, Helmut Brand, Werner Brouwer,
Jan De Maeseneer
Bengt Jönsson (Vice
MEDICINES: p. 71 to 81 that includes this reference and the below recommendations.
The current system of funding R&D through medicine prices encourages
pharmaceutical companies to focus on areas likely to be most
profitable for them rather than areas in which there is unmet need.
The European Union could, however, find more effective ways of funding
R&D to meet health needs (Bloemen and Hammerstein 2012). An interesting line
of development would be to de-link prices and R&D costs (WHO 2012a; WHO
2012b). In 2010, Council Conclusions on the EU’s role in global health asked
Member Sates to explore this option and to ensure that EU investments in health
research secure access to the knowledge and tools generated as a global public
good and generate socially essential medical products at affordable prices.
The European Union can support
Member States in the following ways:
Promote joint action to develop a
strategy to ensure equitable access to new
medicines and new innovative treatments and fairer prices.
Promote transparency to ensure that patents serve the social purpose for which
they were created. This requires detailed knowledge of costs and prices. Wthout this information there is a risk of patent misuse.
Evaluate the possibility of
withdrawing patents in cases of misuse.
Consider setting up a European Parliament committee to analyse the prices of new
medicines. The committee should be guaranteed transparency around costs and prices.
Review the impact of the Supplementary Protection Certificate in ensuring access
to medicines (De Boer 2015).
Link products that have benefited from EU funds such as Horizon 2020 to socially
Explore models to separate the cost of R&D from prices (Council Conclusions May
10, 2010) and extend these to EU countries (not just low
Evaluate and promote the use of joint procurement mechanisms.
Decouple the financing of EU regulator
y agencies (the European Medicines Agency,
EMA) from the pharmaceutical industry. Currently, 83% of the EMA’s budget comes
from the industry via authorisation fees).
Introduce stricter control over conflicts of
All diseases “rare” to evade regulation.
No data on elderly polymedicaton or women specific med impacts.
“There is an attempt to circumvent EMA regulations for the approval of new drugs by making every disease a rare one”, in order to take advantage of fast-track approvals with fewer requirements of clinical trials and provision of data on the efficacy and safety of new medical products.
Rasi was questioned by Spanish Socialist Soledad Cabezón on why the EMA did not evaluate the quality of the medicines compared with those already on the market. She also asked whether the EMA had any plans on making transparent the R and D costs of new medicines as well as improving clinical trial transparency for the sake of health technology assessment. Rasi responded by stating that “commercial” questions were not the competence of the EMA but of the member states. Rasi added that EU member states were capable of evaluating the cost-benefit of the new products if they used their resources wisely.
When asked about TTIP Rasi said that he was not following this issue in detail.
MEP Nessa Childers asked Rasi about the impact of medicines on the elderly and women.
Rasi stated that “We don´t have data or a clear scientific model on the inter-action of the many drugs that elerly people take at the same time. The same goes for women who undergo hormonal changes as they get older that changes the way they react to medicines.” He hoped new research with help. Rasi added that “personalized medicine with surrogate indicators” could be a big help to solve the problems of the elderly and women.
The false competence issue to ECJ
In July the European Commission sent a legal consultation to the European Court of Justice on the issue of whether the Marrakesh Treaty should or should not be ratified under the exclusive competence of the European Union. The reason the EC finally sent the consultation was to prevent a few individual EU member states from ratifying on their own. The ECJ opinion could take between 9 and 18 months but this does not prevent the Council of EU Ministers from ratifying the Treaty at any time. The European Parliament legal service has submitted to the ECJ its very clear opinion in favour of EU exclusive competence along the same lines as the Commission and the Council legal services have expressed. There is no doubt that the Court will rule it is the EU´s exclusive competence to ratify. The consultation can also be seen as a delaying tactic to divert attention from the blockage in the Council.
The other related news is that the European Commission is preparing a “Marrakesh Directive” to better implement the Treaty. The proposal that we hope will be practically a “copy-paste” of the Treaty will probably be out in December. It should be stressed that this is not at all a pre-requisite for ratification and, if it were necessary, could have been done after ratification. As well, the approval of a “Marrakesh Directive” will not in any way change the opposition of some Member States on the competence issue. Nevertheless, we must be alert about the content of this proposal to make sure it has the most favourable interpretation of the Treaty.
German blocking of Treaty
Treaty ratification is now supported by 21 of 28 EU Member States. If Germany changed its negative position, the “blocking minority” in the Council would probably collapse. This calls for political pressure on a political level in Berlin, both in the Justice Ministry and with political parties. To date very few people in the German Government and the Bundestag know anything about Germany´s blocking of the Treaty by using very dubious and totally unsubstantiated arguments: that it is not EU competence, that we need to change German copyright law first and that we need a new EU Directive first. All legal expert have told us the contrary. This is obviously a deceitful political ploy that needs to be exposed. Italy is using the same arguments. The UK´s position on competence is more of a result of the general “euro-skeptic” political ambience.
European Parliament takes action
In the last few weeks both the Legal Affairs Committee and the Petitions Committee have responded positively to the requests of the European Blind Union. Both have decided to send a letter via Martín Schulz, the European Parliament President, to the Luxembourg Presidency of the Council and to Donald Tusk(with copy to Member States), the permanent President of the Council, requesting immediate ratification of the Treaty. We shall circulate the texts when we gain access to them. Other measures, such as a resolution in the EP plenary and a press oriented event have also been requested by the EBU representatives to the Petitions Committee and we are awaiting a reply.