December 7, 2015

The Honorable Michael Froman
Office of the United States Trade
Representative
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 licensing.

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.

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.

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.

Yours sincerely,

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

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:

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

Q&A session

What are some of the possible cures for our ailing and expensive pharmaceutical model?

Introduction by sponsoring MEP

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

• 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

Q&A session

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 a2m.europe@gmail.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

http://ec.europa.eu/health/expert_panel/consultations/access_healthcare_en.htm

approved this opinion for public consultation

by written procedure on 25 September, 2015

Public Consultation is open until November 8^th, 2015

Expert Panel members

Pedro Barros

Margaret Barry, Helmut Brand, Werner Brouwer,

Jan De Maeseneer

(Chair),

Bengt Jönsson (Vice

Chair)

Fernando Lamata

Lasse Lehtonen

Dorjan Maruši?

Martin McKee

Walter Ricciardi

Sarah Thomson

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.

Preliminary opinion:

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

responsible licensing.

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

income countries).

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

interest.

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.

“Marrakesh Directive”

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.

With a clear lack of balance in its approach the EU position in the TTIP negotiations asks for more copyright protections for the renumeration of broadcasters and rights holders but makes no mention of the needs of public interest exceptions for libraries or people with disabiities.

“On copyright, in the EU flagged  the following priorities as areas of offensive interest in the TTIP negotiations: 1) remuneration rights for broadcasting and communication to the public (public performance) for performers and producers in phonograms, 2) a full right of communication to the public (public performance) for authors in bars, restaurants and shops and 3) a resale right for creators of original works of art (Source:EU Position Paper on Intellectual Property, March 2015).” http://keionline.org/node/2281

Sorely missing from this one-sided rights-holder perspective is support for the Marrakesh Treaty for Visually Impaired Persons that permits the cross-border sharing of materials formatted for blind persons around the world. Surprisingly, this copyright and human rights treaty has still not been rartified by the European Union. TTIP could be an opportunity for both the US and the EU to assure swift ratification and implementation of the Marrakesh Treaty.

While the EU is energetically supporting in TTIP and at WIPO a very questionable new layer of copyright protection for broadcasters and their transmissions on the internet (not the content!), it is opposing internationally at WIPO and ignoring in TTIP any progress toward providing copyright flexibilities for the public interest role libraries carry out for preservation and dessemination of science, culture and education.

This monochrome EU copyright strategy for TTIP reflects a total lack of equilibrium between IPR protection and the right to culture of consumers and citizens as a whole.

]]> http://tacd-ip.org/archives/1390/feed 1 http://tacd-ip.org/archives/1388 Thu, 16 Jul 2015 07:52:37 +0000 http://tacd-ip.org/?p=1388 Read more →

Signed by the EU in June 2014, it focuses on copyright exceptions to allow greater distribution of books in formats accessible to visually impaired citizens.

The treaty has cross-spectrum support: a debate calling for ratification at the European Parliament on 24 June was sponsored by members from the left, right and centre, while the President of the European Blind Union, Wolfgang Angermann, calls greater access to such material “a human rights issue”.

Why then, has the treaty not been ratified?

Blocking in Council
Although few publicly oppose the Marrakesh Treaty, seven EU states – three of which have been confirmed as Germany, Italy and the UK – have formed a minority block in the Council and rejected a compromise proposal drawn up under the Latvian Presidency on the conclusion of the treaty.

Four other member states are thought to have sided with them, with EU sources hinting that the Czech Republic and Hungary may be among them.

Sources say that while these member states may not oppose the substance, they are worried about the EU claiming more and more exclusive competence when it comes to international treaties, fearing that this could lead to a ‘slippery slope’.
Campaigner David Hammerstein of the Transatlantic Consumer Dialogue, who moderated the event in Parliament, said their argument over EU competence has been refuted by legal experts.

He said: “It is a very sad commentary about the state of EU affairs if legally baseless competence excuses are used to punish blind persons. The blocking of the treaty is not at all about competence issues: it is about the politically blind incompetence and insensitivity of a few big member state bureaucrats.”
He believes the key to unblocking the dossier in Council is to gain the support of one big member state, such as Germany, whose influence could have a domino effect.

There is also momentum coming from MEP Julia Reda’s copyright report, which advocates swift ratification and which will be voted on in July’s plenary in the European Parliament.

Role of the Commission
The European Commission is also working behind the scenes to get things moving, with representatives from the cabinets of Commissioners Andrus Ansip and Günther Oettinger expressing confidence that ratification could go ahead under the Luxembourg Presidency, although EU sources believe it is too early to say whether the treaty will be prioritised in the coming months.

Speaking privately to Europolitics, disability campaigners say they fear the treaty could be swept aside as focus turns to the more attention-grabbing elements of the digital single market strategy, such as geo-blocking.
While the Commission is working on compromises it hopes will appeal to the remaining seven member states in an attempt to “unblock” the dossier in Council, it seems reluctant to go to the EU Court of Justice, a representative citing this as a last resort.

Campaigners also see this option as time-consuming, unlikely to conclude before 2017, but having waited one year since signing by the EU (and two years for some member states), this route – likely to conclude in the result they want – is becoming more attractive.

ORAL STATEMENT ON OF COPYRIGHT REFORM FOR PRESERVATION BY LIBRARIES AND ARCHIVES

Is our cultural and historical heritage better dead that read? Or is the preservation of our common past a public good that is much better read than dead? If we do not take urgent action much of that legacy will be either lost forever or will remain effectively dead because it will not be accessible to most of the people to enjoy, study or research. Despite living in a digital age some in this room are still defending an information and innovation strategy of scarcity in stark contrast to building socially useful online abundance.

The vast majority of representatives in this room consider preservation a moral and public service responsibility to take international legal measures to preserve our cultural and scientific heritage in the digital environment.

Nevertheless, the complex and incomprehensible jungle of often irrational current copyright laws makes it almost impossible for librarians and archivists, most of whom are not IPR lawyers, to fulfill this responsibility internationally, in cross-border operations with any degree of legal certainty. Should they take the risk of being sued? Here common-sensical social practice conflicts with archaic, chaotic copyright laws that is causing cultural “preservation chill”.

Is it logical or acceptable not to allow legal cross-border shipment archived works? Why is an international solution needed to solve the problem?

An international exception to copyright is needed to permit the supply by one library or archive of a copy of a work to replace a copy of that work that had been preserved in the receiving library or archive but that has now been lost, detiorated or destroyed. An international copyright flexibility is also needed for academic and journalistic researchers to easily access archives and libraries around the world for the common good of advancing science, strengthening freedom of information and restoring cultural equity between countries of the North and the South.

Consumers are overwhelmingly in favour of international cooperation in cultural preservation and sharing of that knowledge.