A2K

On Monday, 17 June 2013, the Supreme Court of the United States released its opinion in Federal Trade Comm'n v. Actavis (formerly captioned as FTC v. Watson Pharmaceuticals, Inc.). The decision, with a 5-3 split, found that pay-for-delay settlement agreements are unusual, raising concerns of anticompetitive behavior, and are not immune from antitrust scrutiny.

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On 13 June 2013, Ambassador Eileen Donahoe delivered the following intervention on resolution L.10/Rev.1 on Access to medicines in the context of the right of everyone to the enjoyment of physical and mental health explaining why the United States called for a vote on this resolution and would abstain.

Explanation of vote, on the resolution entitled “Access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.”

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On 13 June 2013, the long awaited opinion of the Supreme Court of the United States in the case on whether human DNA is patentable was issued and, the last line of the opinion summarizes, "We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material."

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On Thursday, 13 June 2013, at the Twenty-third session of the Human Rights Council in Geneva, Brazil delivered the following intervention introducing draft resolution L.10/Rev.1 on Access to medicines in the context of the right of everyone to the enjoyment of physical and mental health on behalf of India, Brazil, South Africa (IBSA), Egypt, Indonesia, Senegal and Thailand and 27 original cosponsors including Gabon, on behalf of the 54 countries of the African Group.

Mr. President,

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On April 19, 2013, the US Chamber of Commerce wrote a letter to the USPTO to "express concerns about the ongoing meetings of the World Intellectual Property Organization (WIPO) regarding visually impaired persons (VIPs).

David Hirschmann, CEO of the Chamber's GIPC, signed the letter

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In their introduction to Realizing the Right to Health, Andrew Clapham and Mary Robinson provide the following anecdote.

The run up to the 2008 election in the United States focused at one point on the nature of health care in America. During the second presidential debate, the candidates were asked the following question: “Is health care in America a privilege, a right, or a responsibility?” Senator Obama (as he then was) replied as follows:

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On 27 February 2013, Ecuador submitted a paper (IP/C/W/585) to the World Trade Organization's (WTO) Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS Council) titled "Contribution of Intellectual Property to Facilitating the Transfer of Environmentally Rational Technology". This subject was placed under agenda item 11 at the June TRIPS Council's meeting under the heading of "Intellectual Property, Climate Change and Development".

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The following are four US Department of State cables discussing the status of Thailand as regards the USTR Special 301 review. KEI recently received the cables from the US Department of State in response to an earlier FOIA request.

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The WTO TRIPS Council has just approved an extension of TRIPS Obligations for Least Developed Countries until July 1, 2021, a new eight year extension. The new extension comes with some restrictions, but provides more freedom than the previous extension, which had a widely criticized and now eliminated "no rollback" clause. The decision stops well short of what the LDCs had proposed.

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Statement of Knowledge Ecology International in Support of the Unlocking Technology Act (H.R. 1892)
June 9, 2013

The bipartisan Unlocking Technology Act (H.R. 1892), introduced by Representative Lofgren (D-CA) and co-sponsored by Representatives DeFazio (D-OR), Eshoo (D-CA), Holt (D-NJ), Massie (R-KY), and Polis (D-CO) takes the welcome step of scaling back the overprotection of “digital locks” and promoting consumer choice and competition.

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My name is Fedro De Tomassi. I am a student at St. Olaf College, class of 2014, and next week I will be a volunteer (as a guide and interpreter) at the Diplomatic Conference to Conclude a Treaty to Facilitate Access to Published Works by Visually Impaired Persons and Persons with Print Disabilities (June 17 to 28, 2013 – Marrakesh, Morocco) http://www.wipo.int/dc2013/en/

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I was in Geneva today, and was told by several delegates the US is opposing this language in the negotiating text (from the Annex)

[Proposed Footnote: It is understood that Contracting Parties who are members of the World Trade Organization (WTO) acknowledge all the principles and objectives of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and understand that nothing in this Treaty affects the provisions of the TRIPS Agreement, including, but not limited to, the provisions relating to anti-competitive practices.]

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The WIPO diplomatic conference to negotiate a treaty for persons who are visually impaired is slated for 17-28 June 2013 in Marrakech, Morocco. In the context of these negotiations, there have been several discussions regarding the fair use tradition in the United States and whether references to it are important to the treaty.

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Much of the April negotiations on the treaty for copyright exceptions for persons with disabilities was spent discussing the issue of countries that are not members of the WTO, or the Berne Convention, or countries classified by the UN as least developed countries (LDCs), and currently not bound by the TRIPS agreement provisions on copyright.

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WIPO’s development agenda committee unfolds against the backdrop of a looming Millenium Development Goal deadline

3 June 2013

Kirsten Alisha Williams

WIPO’s development agenda committee unfolds against the backdrop of a looming Millenium Development Goal deadline

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On Thursday May 30, 2013, the leaders of the MPAA and the NFB issued a joint statement, followed by a joint press call involving Chris Dodd, the CEO of the MPAA, and Rick Maurer, the President of the NFB. The statement (copy below, called on negotiators to "get back to basics" and set out five principles that a treaty should embody.

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The agenda for the meeting is here: http://tacd-ip.org/archives/945
My slides are here.

El NUEVO REGLAMENTO EUROPEO DE ENSAYOS CLÍNICOS SOBRE HUMANOS

Voto de ayer sobre la transparencia biomédica: lo bueno, lo malo, lo incierto

La presión ciudadana ha sido un éxito parcial en la lucha para la transparencia y ahora debe centrarse en los Estados miembros de la UE que negociará el texto definitivo con el Parlamento.

La confidencialidad comercial: una de cal, una de arena

Si bien es cierto que fue derrotada por una estrecha margen la enmienda legislativa consolidada 40, sí que fue aprobada enmienda consolidada 41 como un recital a pesar de una masiva presión farmacéutica contra. Ambas hablan de no utilizar la confidencialidad comercial como una razón para ocultar los datos de ensayos clínicos. En otras palabras, no existe un dictamen del Parlamento que la autorización de los datos de ensayos clínicos post-mercado deben ser públicos. Además, ITRE 61 también se aprobó que apoya las directrices europeas de Agencia Europea de Medicinas en contra de la excusa de la confidencialidad comercial, precisamente una de las razones por las grandes farmacéuticas están desafiando la EMA en el Tribunal Europeo de Justicia. Todo junto puede dar una interpretación a favor de la transparencia de las otras partes del texto que el Parlamento debe ahora negociar con el Consejo de los Estados miembros de la UE. Por lo tanto, se podría argumentar que el Parlamento considera que no hay datos comercialmente confidenciales en datos de ensayos clínicos posteriores a la autorización de un medicamento.

Requisitos más exigentes para datos públicos

Se ha producido un fortalecimiento de los datos requeridos en los resúmenes de los ensayos clínicos que no han sido autorizados y la exigencia de la publicación de un informe completo los datos clínicos, una vez se autorizan los medicamentos.

Ensayos clínicos comerciales, no comerciales y “de bajo riesgo”

Hay muchos menos requisitos con respecto a la notificación de los resultados de los ensayos clínicos no comerciales o académicos. También hay algunos requisitos para los llamados “ensayos de bajo riesgo”, a menudo con los ensayos de los medicamentos ya autorizados. Existen una preocupación fundada acerca de las definiciones poco claras de una pruebas “no comerciales” y “ensayos de bajo riesgo” y el posible abuso de estas excepciones a información sólida.

Acceso a todos los ensayos: el vaso está medio lleno o medio vacío?

Aunque las empresas serán obligadas a publicar muchos más datos clínicos que en la actualidad, todavía estamos muy lejos de “todas las pruebas, todos los resultados”. No hay requisitos obligatorios para la publicación de datos en bruto en el Reglamento. También hay mucha ambigüedades en la propuesta ley y hay muchas lagunas en las definiciones en el el texto que podrían ser aprovechadas por las grandes farmacéuticas.

 

Citizen pressure has made a big difference for transparency and must now focus on EU member states who will negotiate final text with Parliament.

 

First non-technical short reaction to Clinical Trial Regulation vote on transparency issues. 

 

1. Commercial confidentiality

 

 

While it is true that consolidated legislative amendment 40 was not adopted, consolidated amendment 41 with the same wording was approved as a recital despite massive big pharma lobbying against it. Both speak of not using commercial confidentiality as a reason for concealing clinical trial data. In other words, there is a Parliament opinion that post-market authorization clinical trial data should be public. Furthermore, ITRE 61 was also adopted that refers to European Medicine Agency guidelines on commercial confidentiality, precisely one of the reasons big pharma is challenging the EMA in the European Court of Justice. This can lend a pro-transparency interpretation of other parts of the text as the Parliament must now negotiate the final text of the law with the Council of EU member states. Therefore, it could be argued that the Parliament feels that there is no commercially confidential data in post authorization clinical trial data.

 

 

2. More robust data requirements

   There has been a strengthening of the data required in summaries of clinical trials that have not been authorized and the requirement of the publication of a clinical trial report on clinical data once a drug is authorized.

 

 

 

3. Commercial, non-commercial and “low-risk” trials

 

 

There are significantly fewer requirements with regards to reporting results for non-commercial or academic clinical trials. There are also few requirements for so-called “low-risk trials”, often with trials on medicines already authorized. There are significant concerns about the not very clear definitions of a “non-commercial” trials and “low-risk trials” and the possible abuse of these exceptions to robust reporting.

 

4. All Trials: the glass is half full or half empty. While significantly more data will be required to be published than at present we are still a long way from “all trials, all results”. No complete raw data publication requirements are in the Regulation and there seem to be many loopholes that might be used by Big Pharma.

 

 

 

Access to medicine in Greece:

 

 

Some elements to evaluate the situation on the ground

 

 

1. There exists an access to medicine problem in Greece. Over the last three years of austerity measures and economic crisis significant portions of the population have been excluded from adequate health-care and medical treatments.The introduction of strong measures of co-payment for important medicines is also a cause of exclusion from key treatments.

 

 

2. There have been clear problems both on the supply side (lack of payment, parallel trade) and on the demand side with regards to the lack of rational use of medicines.

 

 

3. Structural problems in medicine market compared to most other EU states. There is still quite a large share of the market occupied by originator-patented drugs while the prices of generic medicines are still relatively high.

 

 

4. Low social acceptance of generic drugs. An important part of Greek public opinion question the quality of generic products and insist upon receiving originator brands. 

 

 

5. “Innovative medicines” are not being given price authorization by the Greek State and they often are not available.

 

 

6. Important lack of key medicines due to the unpaid debts by the Greek State and parallel trade that has led to stock shortages.

 

 

7. Some cancer treatments are specially insufficient with comorbidity being a major issue, as well as unaffordability of certain drugs, such as Herceptin, for breast cancer.

 

 

8. There is major health stress among the immigrant population due to their exclusion from most public health treatments.

 

 

9. There are indications of a major lack of coverage in the vaccination and other problems of health-care for children.

 

 

10. The State health system is increasingly economically unsustainable due to the high unemployment that limits revenue.