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WIPO SCCR28 Day 1: Support for a Broadcasting Treaty Diplomatic Conference in 2015?

Knowledge Ecology International - Mon, 30/06/2014 - 13:12
Standing Committee on Copyright and Related Rights: Twenty-Eighth Session
SCCR/28 June 30 to July 4, 2014 (Geneva, Switzerland)

June 30, 2014. Morning Session
to read the close captioning of SCCR28
http://www.streamtext.net/player?event=WIPO
password: sccr28 during the meeting
Watch live: Standing Committee on Copyright and Related Rights – ow.ly/yAzbf. #SCCR28

Find a few comments and selected interventions:

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For expensive cancer drugs, rationing of access is not the only solution

Knowledge Ecology International - Sun, 29/06/2014 - 11:00

I woke up this morning to read an article by Karol Sikora, a Dean at the University of Buckingham Medical School, about high cancer drug prices.* This quote caught my eye.

quote: "So cancer drug rationing is inevitable in all health economies – rich and poor alike. My solution is to have age limits for expensive therapies. Oncologists have been doing this covertly for the last two decades – it's now time to be explicit."

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Videos from TACD's June 25, 2014 side event on intellectual property in the US, EU trade agreement (TTIP)

Knowledge Ecology International - Thu, 26/06/2014 - 11:32

The following are videos from TACD's June 25, 2014 side event on intellectual property and the proposed Transatlantic Trade and Investment Partnership (TTIP) agreement.

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WTO TRIPS Council (June 2014): Indian intervention on Non-Violation and Situation Complaints

Knowledge Ecology International - Fri, 20/06/2014 - 14:59

On 11 June 2014, India delivered the following statement at the WTO TRIPS Council on on non-violation and situation complaints in response to the US proposal (IP/C/W/599) tabled on 10 June 2014.

NV&S Complaints

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WTO TRIPS Council (June 2014): EU on the contribution of IP to facilitate the transfer of environmentally rational technology

Knowledge Ecology International - Tue, 17/06/2014 - 10:07

On Wednesday, 11 June 2014, the European Union delivered the following statement on the "Contribution of IP to facilitate the transfer of environmentally rational technology technology.'

EU intervention under point 11. Of the TRIPS Council Agenda
"Contribution of IP to facilitate the transfer of environmentally rational technology"

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TTIP: Anti-Transparency Rules laid out in USTR letter to DG-Trade

Knowledge Ecology International - Thu, 12/06/2014 - 21:13

KEI has obtained the terms of reference (TOR) for the confidentiality of the negotiating texts of the Transatlantic Trade and Investment Partnership (TTIP) Agreement. The TOR are laid out in a two-page letter from US Chief Negotiator Dan Mullaney to EU Chief Negotiator Ignacio Garcia-Bercero which is available here. The letter was obtained through a FOIA request filed by KEI with the USTR on May 19, 2014.

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TRIPS, the European Commission and the European Medicines Agency´s clinical trial transparency policy

Trans Atlantic Consumer Dialogue - Thu, 12/06/2014 - 13:43

Nothing in international intellectual property law constitutes a serious barrier to the publication of clinical trial data for the sake of public health.

 

In his letter to the European Ombudsman dated 22 May 2014, the Director of the European Medicines Mr Rasi refers to a “clear message” of the European Commission relating to the need to ensure compliance with national and international agreements, including, but not limited to, TRIPS and copyright legislation. It can be deduced that the EMA has received a “clear message” that its “proactive” clinical trial transparency policy could be violating international IPR law.

 

One cannot derive from TRIPs article 39.3, that refers to clinical data, any general obligation against the disclosure of clinical trial data.This is clear in the text itself:

‘Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.’

Moreover, a number of interpretations of TRIPs clarify that the disclosure of clinical trial data for the sake of transparency and public health cannot be considered “unfair commercial actvity” (which is not defined). A number of WHO/WTO documents insist that clinical trial disclosure and article 39.3 of TRIPs should be seen within the context of the Doha Declaration on flexibilities for Public Health. See this WHO document: http://www.who.int/medicines/areas/policy/protection_of_data.pdf and from the WTO http://wto.org/english/res_e/booksp_e/pamtiwhowipowtoweb13_e.pdf;

It is true that to date there is no case law precedence nor other very authoritative interpretations on the TRIPs articles referring to clinical trial data. But in this context it specially surprising that the European Commission (DG Trade and DG Enterprise) is pressuring the EMA to roll-back on its data transparency measures with the pretext of international patent, trademark and copyright concerns that are not backed up by a clear legal basis.

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WTO TRIPS Council (June 2014) - India's intervention on Intellectual Property and Innovation: Innovation Incubators

Knowledge Ecology International - Wed, 11/06/2014 - 16:28

On Wednesday, 11 June 2014, India delivered a statement at the WTO TRIPS Council on"Intellectual Property and Innovation: Innovation Incubators"; Chinese Taipei (WTO speak for Taiwan) and the United States proposed this agenda item.

We thank the delegations of the United States and Chinese Taipei for tabling an agenda item on "Intellectual Property and Innovation: Innovation Incubators " which we understand is a standalone item.

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WIPO: Africa Group Statement on the Formal Integration of PPH system to PCT

Knowledge Ecology International - Wed, 11/06/2014 - 15:55

WIPO's Patent Cooperation Treaty (PCT) Working Group is meeting from 10 June 2014 to 13 June 2014. Among the hot topics of discussion is a paper tabled by the United Kingdom and the United States on Formal Integration of the Patent Prosecution Highway into the PCT. The basic ask of the UK/US proposal (PCT/WG/7/21) is to amend the regulations of WIPO's PCT Regulations and Administrative Instructions to formally integrate the Patent Prosecution Highway (PPH) into the PCT system.

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WTO TRIPS Council (June 2014): USTR submission on Non-Violation Complaints Under the TRIPS Agreement

Knowledge Ecology International - Wed, 11/06/2014 - 07:36

On 10 June 2014, the United States tabled a paper (IP/C/W/599) to the World Trade Organization's (WTO) TRIPS Council on "Non-Violation Complaints Under the TRIPS Agreement." This paper is expected to be discussed at the TRIPS Council today (11 June 2014) under agenda item 7 on "Non-Violation and Situation Complaints."

As previously mentioned in our February 2014 piece,

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World Health Assembly (WHA 67) agrees to create pooled R&D fund, endorses delinkage of R&D costs from product prices

Knowledge Ecology International - Sat, 24/05/2014 - 10:45

Today the World Health Assembly (WHA) reached consensus on a "decision", WHA67(15), regarding the Consultative Expert Working Group (CEWG) on Research and Development.

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WHA67: Statement of South Africa on behalf of the African Region on Access to Essential Medicines

Knowledge Ecology International - Fri, 23/05/2014 - 10:08

On Friday, 23 May 2014, the World Health Assembly is currently discussing access to essential medicines in the context of resolution EB134.R16, tabled China in January 2014. The following statement was delivered by South Africa on behalf of the 47 members of the African region. South Africa highlighted the point that "vaccines and anti-cancer drugs remain out of reach of millions of people in both developed and developing countries."

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KEI Notes on TTIP 5th Round: How to engage in a dialogue without access to the text?

Knowledge Ecology International - Thu, 22/05/2014 - 20:47

Wednesday, at the George Mason University Law Campus in Arlington, VA, the Office of the US Trade Representative hosted an all day Stakeholder Forum in conjunction with the fifth negotiating round of the Transatlantic Trade and Investment Partnership. The first part of the day was devoted to Stakeholder Policy Presentations, with several hours of presentations by a variety of industry, academics, trade associations, and public interest groups. The latter part of the day consisted of a briefing by the US Chief Negotiator Dan Mullaney and the EU Chief Negotiator Ignacio Garcia-Bercero.

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67th WHA Side Event on Innovation and Access for Middle-Income Countries, Wednesday 21 May 2014

Knowledge Ecology International - Tue, 20/05/2014 - 19:01

This Wednesday 21 May 2014, Knowledge Ecology International (KEI), Civil Society Coalition, Medecins Sans Frontieres (MSF), Oxfam, Health Action International (HAI) and Treatment Action Group (TAG) will host a side event at the WHA on, "Innovation and Access to Medicines and Vaccines: Emerging Challenges and Opportunities for Middle-Income Countries."

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Call for Action on Cancer Drugs by YP-CDN, KEI, and UAEM at 67th World Health Assembly

Knowledge Ecology International - Mon, 19/05/2014 - 21:01

At the opening of the 67th World Health Assembly, today the Young Professionals Chronic Disease Network (YP-CDN), Knowledge Ecology International (KEI), and Universities Allied for Essential Medicines (UAEM) released a briefing, "Cancer medicines are essential in reducing the global burden of non-communicable diseases."

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Human rights vs. patent monopolies on medicines in Greece

Trans Atlantic Consumer Dialogue - Thu, 15/05/2014 - 11:19

Human rights VS Patent Monopolies on medicines

Written by Mr. Panayotis Kouroublis, Greek MP, SYRIZA parliamentary representative

Published at http://www.koutipandoras.gr/article/113023/anthropina-dikaiomata-enantion-pneymatikon-dikaiomaton on 3 May 2014

 

“Diseases such as cancer are considered urgent only when the patient is in the final stage” according to the Greek Minister of Health Adonis Georgiadis in the “Wall Street Journal”. This is the response of the Ministry of Health in relation to the uninsured cancer patients who are forced to discontinue their treatment because they cannot afford it. The blatant cynicism displayed by the government is not only due to the dogmatic faith of the Greek government in the agreements with the Troika but also due to the government’s incapacity to effectively address a series of problems. Minister Georgiadis stresses that there is no room for flexibility in the austerity measures. Nevertheless, solutions  are feasible and are foreseen by international law. Most importantly, these have already been implemented by other European countries.

 

The WTO TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement enables a country facing an emergency to issue a compulsory license for products protected by copyright. If Greece decided to use this legal provision, it could obtain anticancer and other drugs at much cheaper prices while bypassing, in an entirely legitimate manner, the patents held by multinationals. Compulsory licensing has been used in numerous countries including Germany, Italy and the USA. This solution should be taken into account by the Greek government which nonetheless refuses to examine it, despite its proven efficacy. Another solution that is worth considering would be the collective supply of medicines (pooled procurement) by several EU member states joining forces. If Greece decided to negotiate with pharmaceutical companies together with other countries of southern Europe; it could obtain much cheaper prices for much-needed medicines.

 

The current government is accountable to the Greek people because of its persistent refusal to take advantage of the considerable flexibility provided by the European and international context as regards the supply and procurement of drugs. This is the least, a responsible leadership should have done in view of the humanitarian crisis, the country is faced with. For SYRIZA; the political force fighting for the peoples of Europe and not the multinationals, the bar stands even higher. As a leading opposition party in a country found at the heart of the European financial  crisis;  SYRIZA’s leader, a candidate for the Presidency of the European Commission will strive to  broaden the scope for a different Europe. SYRIZA must question the overall status quo of pharmaceutical research funding, which results in the exclusion of millions of patients from health care to the benefit of some big pharmaceutical companies.

Funding for research into new drugs based on intellectual property creates legal monopolies that favour the companies that have developed these drugs. In essence , the company that owns the patent of a drug is the only one entitled to sell it and it can do so at any price it wishes. Big pharmaceuticals argue that this is the only way to meet the high costs of research and development. The truth is that the cost of R&D constitutes a very small percentage of the  total cost of developing a new medicine. In other words, expensive price tags are a way for profiteering for big companies while putting human lives at risk. It is indicative that prices of anticancer drugs have doubled over the last decade; despite angry reactions by doctors and patients’ associations .

 

The current patent system results in prohibitive costs for patients as well as in a huge waste for healthcare providers. It most importantly raises a wall between the drugs and those who need them the most. It has additional side effects: such as the development of drugs with questionable efficacy, the encouragement of agreessive and misleading  promotional practices on behalf of major pharmaceuticals and the obstruction of the development of new, better and affordable drugs. On the whole; the present system of the financing of medical innovation is manifestly unfair, wasteful, ineffective and undermines the right to health of Greeks and Europeans.

 

The goal should be to “delink” the incentives for research and development from the high prices of patented originator drugs. This can be achieved by setting up a fund for rewarding pharmaceutical innovation to which EU Member States will contribute.This Fund will reward research efforts of private and public entities driven by health outcomes with a view to promoting further research for the benefit of patients. This way companies will be compensated for the costs of research, while the medicinal products will be available in free competition with generics.  To this end, drug approval will be under the strict supervision of European and national authorities to ensure the quality .

 

This is something not unheard of. Under pressure from patients’ associations , health professionals and activists, such proposals have long been discussed at the World Health Organization and the U.S. Congress. The proposed system is much fairer providing a) lower prices and access to life-saving treatments while b) reducing costs for healthcare providers. Finally, it is far more efficient, since it seeks to serve real health needs and not artificial ones created by companies’ marketing strategies.

 

Europe must prioritise the right of patients to the drugs they need over the right of companies to a monopoly. Today, it is more pertinent than ever. In today’s Greece, where patients literally fight for their lives; their call should be heard across Europe; human rights are more important than multintionals’ intellectual property rights.

 

Health is the most critical, but not the only sector where large companies impose their rule by force of intellectual property rights. In recent years the proliferation of IPR in many unrelated fields, from seed growers to software developers and from cultural projects to any kind of scientific achievements; the product of human creativity is captured by large companies using IPR monopolies. Society is thus deprived from the most valuable good in the era of information: free access to knowledge.

 

Proponents of strict patents laws overlook the fact that in science, as in arts, there is no parthenogenesis. The essence of human progress is to copy and modify previous works in order to improve them. Moreover, major scientific achievements rarely are the result of profit-oriented research. These are most often achieved ??by individuals or groups with humanitarian motives experimenting freely with the works of their predecessors. The global free software community that produces innovative and reliable products pro bono capitalizing on existing knowledge without restrictions is another tangible proof. The same was true in the 17th century when Sir Isaac Newton gave credit to Galileo and Kepler, saying : “If I saw farther , it is because I stepped on the shoulders of giants.”

 

Large multinationals attempt to go against the tide of the dynamism we experience today by trying to control, manipulate and direct intellectual property through legislation. During the ongoing negotiations for the new Transatlantic Free Trade and Investment Partnership Agreement (TTIP), the EU should stay away from instituionalising the demands of industry. There should be a new set of rules which will foster innovation and creativity where access to knowledge will be governed by the principles of freedom, justice and equity .

 

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EP Elections pledge: Europe for access to medicines and public health care

Trans Atlantic Consumer Dialogue - Wed, 14/05/2014 - 10:13

10 commitments for candidates to the European Parliament

1. Defend universal access to public health care systems without discrimination for reasons of economic capacity, employment status or nationality. Support the principle of the integration of health aspects into all European policies. Call upon the intervention of the European Commission if the right to health is violated, especially in countries affected by EU mandated public debt reduction policies.
2. Demand the carrying out of an independent health impact evaluation before any substantial financial cut-backs of public health systems when they occur within the context of EU supported austerity measures.

3. Support the creation of a EU fund for health-care solidarity to help EU member states where a hight number of people remain without health-care coverage as a result of EU mandated austerity measures.

4. Promote transparency and public access to data from all clinical trials for existing and new biomedical products.

5. Foster EU cooperation on health technology assessment and promote the use of transparent, unbiased, and robust methodologies to measure the effectiveness and added value of new medicines and technologies

6. Ensure the effective application of the EU Research Programme Horizon 2020 provisions that mandate open access policies for scientific articles and data generated from research financed with EU funding. Support EU policies such as innovation prizes that promote de-linkage between biomedical R and D costs and the price of new medicines.

7. Call for for a new binding EU regulation that demands transparency and full disclosure of the economic relationship between doctors and the pharmaceutical industry.

8. Defend strict EU norms in favour of socially responsible licencing policies for biomedical innovation that has received EU funding.

9. Support the issuing of compulsory licences to guarantee the affordable access to very high-priced life-saving drugs with great evidence of efficacy, such as the case of a treatment against hepatitis C and a few anti-tumoral medicines.

10. Promote fair and equitable EU international trade and development policies that facilitate universal access to essential medicines and that support strong EU funding for research on “neglected” and tropical illnesses that tend to affect countries of the Global South.

Send your support to: david@davidhammerstein.org and teresa.salinas@saludpordercho.org

Declaration written and coordinated by Working Group on Health, Medicines and Innovation (GTSMI), TransAtlantic Consumer Dialogue,  Salud Por Derecho saludporderecho.org, Médicins du Monde, Spain, Pharmacists without Borders, Spain,  Confederation of Consumers and Users, Spain, and No Gracias, among other groups and individuals.

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WIPO fails to reach agreement to convene a Diplomatic Conference for adoption of the Design Law Treaty

Knowledge Ecology International - Sat, 10/05/2014 - 05:44

On Thursday, 8 May 2014, the General Assembly of the World Intellectual Property Organization (WIPO) appointed Francis Gurry as Director General for a second term. This second term would run from 1 October 2014 to 30 September 2020.

The General Assembly also addressed the following topic: "Consideration of the Convening of a Diplomatic Conference for the Adoption of a Design Law Treaty." At the close of business on Friday, 9 May 2014, the General Assembly could not reach consensus on convening a Diplomatic Conference on concluding the Design Law Treaty.

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Copyright meets broadcasting in Geneva

Trans Atlantic Consumer Dialogue - Thu, 08/05/2014 - 17:06

 

The 27th session of the World Intellectual Property Organization´s Standing Committee on Copyright and Related Rights (SCCR) took place from 28 April to 2 May in Geneva. The Committee assessed the proposal for a Broadcasting Treaty.

 

This initiative for a new binding global copyright treaty has been discussed at WIPO for over 10 years at the request of many broadcasters from around the world. This week, several WIPO member states, including the EU, Russia and South Africa called for a diplomatic conference on this treaty in 2015. Nevertheless, there are many questions that remain to be answered, in particular regarding the scope and even the need for such a new global norm. The EU is the strongest supporter of the Treaty while a number of other large countries, such as the US, Brazil and India, are quite sceptical.

 

According to the broadcasters, a new treaty is needed to prevent “signal piracy”, although it has not been clearly established what signals they wish to protect, whether they are speaking of fixed emissions, simultaneous webcasting, deferred online programming or online retransmissions. There has also been no evidence presented about the harm caused by “signal piracy”.

 

Many other voices have pointed out that this new treaty would establish yet a new layer of copyright protection and economic rights for broadcasters as intermediaries or distributors of information they do not own and they did not create. Consumers and internet users have also stated fears that the treaty would make it more expensive and complex to legally obtain, access and to use information. There is also worry that new technical protection measures will create new barriers to what is now legally allowed by copyright law in countries with more flexible norms.

 

Representatives of collecting societies, performers and authors have criticised the Broadcast Treaty proposal as possibly interfering with the normal of copyright protection for creators. A few citizen groups have also called for an impact study to be carried out on the possible consequences of this treaty on users, performers and authors.

 

When on 2 May, the time came to adopt conclusions and the next steps for WIPO concerning the Broadcast Treaty, the member states were unable to reach any degree of minimum consensus. The collapse of the talks and the absence of any general conclusions or decisions did not happen because of the differences of opinion on the Broadcast Treaty but because of the other issue being considered simultaneously by WIPO: exceptions and limitations for libraries. The EU expressed its profound opposition to any “text-based” consideration of new copyright flexibilities for libraries for conservation, orphan works, scientific research and e-book sharing, among other issues. In response to the EU´s uncompromising stance, other countries, such as Brazil, decided to withdraw their support for the compromise reached to continue serious discussions on the Broadcast Treaty. At 1:30 am on 3 May the meeting adjourned with no agreement on how to proceed on both the Broadcast Treaty and Libraries.

 

SCCR 27 WIPO *New* Broadcasters’ Treaty: Impact on Rights Owners (30.04.2104)
http://keionline.org/node/1995

 

At WIPO, Authors, Civil Society Watchful Of Rights For Broadcasters (01.05.2014)
http://www.ip-watch.org/2014/05/01/at-wipo-authors-civil-society-watchful-of-rights-for-broadcasters/

 

EFF – Broadcasting Treaty
https://www.eff.org/issues/wipo-broadcasting-treaty

 

WIPO: Scope and rights of potential broadcasting treaty clarified (05.05.2014)
http://www.twnside.org.sg/title2/intellectual_property/info.service/2014/ip140502.htm

 

Protection of Broadcasting Organizations – Background Brief
http://www.wipo.int/pressroom/en/briefs/broadcasting.html

 

(Contribution by David Hammerstein – TransAtlantic Consumer Dialogue)

Published in http://edri.org/copyright-meets-broadcasting-in-geneva/

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Decision point for WIPO General Assembly May 2014: Convening a Diplomatic Conference to conclude the Design Law Treaty

Knowledge Ecology International - Thu, 08/05/2014 - 14:36

On Thursday, 8 May 2014, the General Assembly of the World Intellectual Property Organization (WIPO) appointed Francis Gurry as Director General for a second term. This second term would run from 1 October 2014 to 30 September 2020.

At 5 PM (CET), the General Assembly will address the following topic: "Consideration of the Convening of a Diplomatic Conference for the Adoption of a Design Law Treaty."

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