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Twenty groups write Congress, no fast track without public access to trade agreement negotiating texts

Knowledge Ecology International - Fri, 20/03/2015 - 21:09

Twenty groups, including KEI, have written Congress, asking the Congress to provide public access to draft trade agreement texts and U.S. proposals throughout negotiations, and to specific that only agreements developed through such processes should obtain any expedited congressional consideration.

Among other things, the groups said:

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KEI, KEI Europe, and Essential Inventions ask five companies for licenses to HCV patents

Knowledge Ecology International - Wed, 18/03/2015 - 17:36

On March 18, 2015, KEI, KEI Europe, and Essential Inventions submitted proposals for global voluntary licences for all patents necessary for hepatitis C (HCV) medicines to five drug companies -- AbbVie, Bristol-Myers Squibb, Gilead, Janssen, and Merck.

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Pharma is moving fast: What is coming up in pharmaceuticals in Europe

Trans Atlantic Consumer Dialogue - Tue, 17/03/2015 - 08:18

by Yannis Natsis (17/03/2015)

I recently attended a seminar in Brussels on medical innovation beautifully hosted by an important pharmaceutical company. As always, the setting was ideal. Fancy 5 star hotel, delicious buffet lunch and lots of people working in public relations. The composition of the panel followed the usual recipe successfully tried in corporate events: An esteemed member of the academia, a president of a European patient federation, a classy pharmaceutical executive, an influential certainly pro-business EU public official and an expert. Last but not least, the discussion was moderated by an excellent American facilitator.

As the presentations kicked off, the University professor emphasized the incredible economic significance of the pharmaceutical sector for jobs and growth Europe and reminded everyone that the patent system needs to be defended by all means as this is one of the very few guarantees for innovation. Innovation was underlined by the patient representative too along with repeated and rather emotional calls for patients’ timely access to new treatments in order to meet “unmet” medical needs. The pharmaceutical representative stressed that her sector invests considerable amounts of money in research and development of life-saving treatments. She added that in spite of the very high failure rates, pharma companies do not give up because “human lives are at stake”. The public official agreed and reassured her that her business’ aspirations are taken on board by EU policy-making institutions. Last but not least, the independent expert reaffirmed the need for higher patent protection and stronger enforcement of intellectual property rights as the way forward.

During the Q&A session, the high cost of medicines was briefly touched upon only to be overshadowed by voices claiming that non-treatment costs society more and that patient outcomes should be the guiding criterion in cost-effectiveness assessments. As the icing on the cake, the public official noted that the absence of streamlining of regulatory and reimbursement requirements leads to higher costs for drug development and consequently to higher end prices. The patient representative along with people from the audience reiterated the necessity to institutionalize the early dialogue between all stakeholders, increase public funding and expedite access to new treatments. Accessibility” of medicines was another highlight of the day seen under the prism of “innovative” methods of bringing drugs to European citizens through adaptive licensing, differentiated pricing, prolonged payment of curative treatments and a more active role of patients in the authorization procedure of new medicinal products.

The meeting came to a close and I felt puzzled. “Early dialogue”, “speedy access to new treatments”, “patient outcomes”, “innovation saves lives”, “innovative payment methods”, “streamlining of regulatory requirements” were all familiar themes and at the end of the day, they make sense and do sound nice. It struck me however that new battlegrounds are appearing as pro-industry lobbies work proactively to guide future European legislation. On the EU level, there is a consistent effort to review and eventually redesign the drug development pathway from discovery to product launch and post authorization monitoring to make industry’s life easier to the detriment of public interest. To this end, the pharmaceutical industry is shaping the agenda by choosing its facts and promoting a language that is easily owned by everyone. Let’s examine some of this rhetoric but from a different perspective, that of thinking of health in terms of a public good and not merely a business.

Early dialogue of all stakeholders (regulators, payers, European Medicines Agency-EMA, Health Technology Assesment-HTA bodies): as there are multiple levels of competences and evaluation criteria split between the EU and the member states during the different phases of drug development, industry wants to guarantee that it has a decisive say in the process early on. They want a detailed overview and a reserved place around the table during the market approval phase and the very important pricing and reimbursement stage. Adaptive licensing & parallel scientific advice are two of the main EU initiatives in this direction.

Early and “speedy” access to medicines: this is the prevailing theme in the EU legislative bodies at the moment. The Council is currently reviewing the existing mechanisms of early access such as conditional approval, compassionate use, and approval under exceptional circumstances. The risks are that very expensive medicines will enter the market faster on fewer reliable clinical trial data and a higher chance of unforeseen adverse effects.

Convergence of evidence requirements: in the spirit of “early dialogues”, industry pushes for a convergence of criteria in relation to market approval, the health technology assessment and the reimbursement phase employed by the different organisations in charge of these stages. Moreover, they highlight the primacy of the European Medicines Agency (EMA) as they do not wish to face additional hurdles from national regulatory authorities. This way they can predict what is coming up and how to tailor the different evaluation stages to their capacity.

Pricing & reimbursement decisions: this is probably the most important stage as it determines patients’ access to a treatment. Market approval is (or at least should be) based on scientific criteria in order to evaluate the efficacy, quality and safety of a drug. This makes it de facto more predictable i.e. more manageable. On the contrary, pricing & reimbursement is and has always been a political decision based on a different set of criteria.

HTA bodies: these are crucial for evaluating the added therapeutic value of new medicines. Therefore, HTA bodies are increasingly regarded as gatekeepers against the flood of me-too medicines that offer modest or no real therapeutic value but usually cost a fortune to public health systems in Europe and beyond. The more HTA’s role grows as part of the regulatory framework, the more they are targeted by pharma. This is due to the HTA’s distinct and instrumental role in introducing the concept of “therapeutic added value” into the market authorization procedure. This concept signals a higher threshold for the entry of new truly innovative medicines. The EMA –whose independence and capacity to control conflicts of interest are doubtful- is currently running pilot projects on adaptive licensing and parallel scientific advice that may a) threaten HTA bodies’ independence, b) weaken the regulatory framework, and c) lower safeguards.

Cost-effective, synergies between all stakeholders: emphasis is placed on cost-effectiveness against cost-benefit analyses. Moreover, industry and the EMA’s pilot projects aim to redesign the traditional licensing path with a view to putting their products earlier on the market while relying on fewer clinical data. It is worrisome that the language used in adaptive pathways (initially named adaptive licensing) widens the scope for the entry of new medicines referring to all medicines and not only those to treat unmet medical needs.

Views on early access vary considerably among EU member states as there are economic concerns especially for those where full reimbursement of treatments is foreseen. That is why, when it comes to HTA, they favour closer cooperation but wish to keep the final assessment on the added value strictly on a national level and oppose any efforts towards a single European HTA. In the meantime, the European Commission has announced that it will conduct a study to compare how member states implement the various early-access schemes-they want to make sure that there is no market distortion, referring to off-label use. The role of patient associations in this debate cannot be overlooked. They are often encouraged by pharmaceutical companies to put pressure on governments to demand early access to treatments as is the case with the seemingly private Dutch initiative presented via mytomorrows.com which is heavily propagated in the Council by the Netherlands.

There may be no new attention-grabbing legislation coming up but all of these initiatives and pilot projects need to be closely monitored as they influence ongoing debate and most importantly future legislation. On the whole, should pharma’s strategy be successful, it will result in an ever closer incestuous cooperation between the regulator and the regulated where any independent scrutiny of new medicines and their prices could be seriously weakened.

Categories: Front page

HRC28: Statement of the European Union- Cultural Rights (Response to SR Report on Copyright and Right to Science and Culture)

Knowledge Ecology International - Thu, 12/03/2015 - 16:56

On Wednesday, 11 March 2015, Oliver Hall-Allen, First Counsellor, Delegation of the European Union to the United Nations Office in Geneva delivered the following statement in response to the presentation of the Special Rapporteur in the Field of Cultural Rights (Farida Shaheed) on her Report on Copyright policy and the right to science and culture (A/HRC/28/57).


Oliver Hall-Allen (blue tie, white shirt), First Counsellor, Delegation of the European Union to the United Nations Office in Geneva

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HRC28: Statement of the United States of America - Cultural Rights (Response to SR Report on Copyright and Right to Culture)

Knowledge Ecology International - Thu, 12/03/2015 - 00:19

On Wednesday, 11 March 2015, Ambassador Keith Harper, U.S. Representative to the Human Rights Council, delivered the following statement to the 28th Session of the Human Rights Council on the topic of cultural rights.

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HRC28: Statement by Farida Shaheed, Special Rapporteur, on Copyright policy and the right to science and culture

Knowledge Ecology International - Wed, 11/03/2015 - 11:45

On Wednesday, 11 March 2015, Farida Shaheed, the United Nations Special Rapporteur in the field of cultural rights presented her seminal report on Copyright policy and the right to science and culture (A/HRC/28/57) at the 28th session of the Human Rights Council in Geneva.

Highlights from the report's recommendations include the following:

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WTO at 20: Symposium on the TRIPS Agreement for TRIPS Council Members and Observers (26 February 2015)

Knowledge Ecology International - Wed, 04/03/2015 - 17:22

As part of the World Trade Organization's (WTO) technical assistance and capacity building program, on Thursday, 26 February 2015, the WTO Secretariat convened Symposium on the TRIPS Agreement for TRIPS Council Members and Observers which brought together negotiators from the 1986–94 Uruguay Round to discuss how the Round introduced intellectual property norms into the architecture of the multilateral trading system. In addition, other experts were brought in to discuss what has happened since the introduction of the TRIPS Agreement, and what augurs for the future.


The Uruguay Round- The Glory Years, Source: World Trade Organization

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St Jude's influenza patents, with US government rights

Knowledge Ecology International - Tue, 03/03/2015 - 15:19

St Jude holds 24 patents with influenza in the specification, that also disclose US government rights. Some of these were discussed here: http://keionline.org/node/2188

PAT. NO. Title
1 8,574,592 Modified influenza virus for monitoring and improving vaccine efficiency
2 8,551,481 Anti-cancer vaccine composition comprising an anti-CD223 antibody and kit comprising an anti-cancer vaccine and an anti-CD223 antibody
3 8,309,099 DNA transfection system for the generation of negative strand RNA virus

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CDC FOIA regarding intellectual property on avian flu intellectual property rights

Knowledge Ecology International - Tue, 03/03/2015 - 14:53

Our 2009 FOIA request, and 42 pages of CDC emails debating what to give us.

http://keionline.org/misc-docs/FOIA/14-01041-cdc-foia-frequest-2009.pdf

The February 17, 2015 cover letter from CDC.
http://keionline.org/sites/default/files/CDC_17feb2015_FOIA_CoverLetter.pdf

The 184 page CDC foia response, which we received in February 2015. Note that we were particularly interested in the patent issues related to reverse genetics.

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KEI Special 301 supplemental comments: Compulsory Licensing not restricted to "Emergencies" or "Measure of Last Resort"

Knowledge Ecology International - Sat, 28/02/2015 - 23:38

At the February 24, 2015 USTR hearing on Special 301, KEI asked to provide supplemental comments on R&D for the record, and KEI was separately asked by USTR to provide comments on online pharmacies, and by DHHS to comment on the relationship between emergencies and compulsory licensing. (The KEI page on Special 301 is here: http://keionline.org/ustr/special301).

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KEI's supplemental comments in USTR 301: Online pharmacies, parallel trade and counterfeit drugs

Knowledge Ecology International - Sat, 28/02/2015 - 23:19

At the February 24, 2015 USTR hearing on Special 301, KEI asked to provide supplemental comments on R&D for the record, and KEI was separately asked by USTR to provide comments on online pharmacies, and by DHHS to comment on the relationship between emergencies and compulsory licensing. (The KEI page on Special 301 is here: http://keionline.org/ustr/special301).

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KEI's Feb 27, 2015 Supplemental Comments to USTR Regarding Research and Development

Knowledge Ecology International - Sat, 28/02/2015 - 23:05

At the February 24, 2015 USTR hearing on Special 301, KEI asked to provide supplemental comments on R&D for the record, and KEI was separately asked by USTR to provide comments on online pharmacies, and by DHHS to comment on the relationship between emergencies and compulsory licensing. (The KEI page on Special 301 is here: http://keionline.org/ustr/special301).

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WTO TRIPS Council (February 2015): EU mounts defense of tobacco plain packing measures in the Republic of Ireland and the UK

Knowledge Ecology International - Fri, 27/02/2015 - 10:56

The following statement was delivered by the European Union on Tuesday, 24 February 2015 at the WTO TRIPS Council during discussions on "Concerns with respect to proposals for plain packaging of tobacco products in the United Kingdom and Ireland".

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A few reactions to the USTR Special 301 Hearing

Knowledge Ecology International - Wed, 25/02/2015 - 21:34

On Wednesday February 24, 2015, the United States Trade Representative (USTR) Special 301 Committee held its annual public meeting following written comments sent earlier by trade associations, corporations and a few public interest groups that follow trade and intellectual property.

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KEI comments at February 24, 2015 USTR Special 301 Hearing

Knowledge Ecology International - Wed, 25/02/2015 - 13:37

On February 24, 2015, the USTR convened the Special 301 Review, taking testimony almost exclusively from witnesses representing large corporate rights holders. Over the course of the three-and-a-half hour hearing, groups such as Phrma, NAM, IPO, and the misleadingly-named Alliance for Fair Trade with India (an alliance comprised of groups such as Phrma, NAM, MPAA and many other similar groups) as well as foreign-owned multinational Bridgestone, pushed for the watch-listing of countries that fail to implement TRIPS+ measures.

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WTO TRIPS Council (February 2015): Bangladesh statement (on behalf of LDC Group)- Extension of the 2016 transitional period

Knowledge Ecology International - Wed, 25/02/2015 - 11:58

On Tuesday, 24 February 2015, Bangladesh, on behalf of the LDC Group, presented the submission of the LDC Group on an Extension of the Transitional Period Under Article 66.1 of the TRIPS Agreement for LDC Members for Certain Obligations with Respect to Pharmaceutical Products in the following impassioned statement.

ANY OTHER BUSINESS

EXTENSION OF THE TRANSITION PERIOD UNDER ARTICLE 66.1 OF THE TRIPS AGREEMENT FOR LEAST-DEVELOPED COUNTRY MEMBERS FOR CERTAIN OBLIGATIONS WITH RESPECT TO PHARMACEUTICAL PRODUCTS

Mr. Chair

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WTO TRIPS Council (February 2015): LDC Group statement on Non-Violation and Situation Complaints

Knowledge Ecology International - Wed, 25/02/2015 - 11:50

On Tuesday, 24 February 2015, Bangladesh, on behalf of the LDC Group delivered the following statement on non-violation and situation complaints.

AGENDA 6: NON-VIOLATION AND SITUATION COMPLAINTS

Mr. Chairman,

I am taking floor on behalf of the LDC group.

LDCs are concerned that non-violation and situation complaints may pose unnecessary problems to LDCs which can be otherwise avoidable if we do not implement this provision under TRIPS.

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Guessing for medicine patents, TTIP and ISDS in action

Trans Atlantic Consumer Dialogue - Tue, 24/02/2015 - 14:12

 

Big pharmaceutical companies sometimes try to flout evidence-based innovation when they attempt to claim patents for wildly different illnesses with the same medicine and then sue the state with TTIP-like “investor protection” mechanisms if their patent applications are denied.

Pharma giant Eli Lilly has sued the the Canadian Government for 500 million dollars in compensation for the invalidation of patents that Canadian Courts had found had failed to comply with patentability requirements while Canadian authorities have accused Eli Lilly of “guessing for patents” and “not adequately disclosing innovation to the public”.

Believe it or not, for the anti-psychotic drug Olanzapine, the Canadian Government listed 16 patent applications for many different disorders: for excessive aggression, fungal dermatitis, bipolar disorder, sexual dysfunction, insomnia, nicotine withdrawal, tic disorder, anorexia, autism, mental handicaps, pain, substance abuse and Alzheimer’s disease.

For the attention-deficit drug Atomoxetine, Eli Lilly had filed for 12 separate patents between 1992 and 2004 claiming it could treat psoriasis, stuttering, incontinence, hot flashes, anxiety, learning disabilities, tic disorders and, finally, Attention-deficit disorder.

It all sounds like a farfetched joke but it is sadly true. If “investor protection” mechanisms like ISDS are not removed from TTIP, all of the EU could soon be turned into the wild west of “scattershooting” for medicine patents under the threat of being sued by big pharma. What would be badly damaged is not only evidence-based innovation that benefits the common good but, as well, the democratic sovereignty of national courts and legislatures.

See <http://www.thestar.com/business/2015/02/11/canadian-reply-to-500-million-us-pharma-suit-guesses-dont-make-valid-patents.html>


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WTO TRIPS Council (February 2015): LDC request for extension of the transitional period for pharmaceutical products

Knowledge Ecology International - Tue, 24/02/2015 - 11:58

The World Trade Organization (WTO) is convening the TRIPS Council from Tuesday, 24 February 2015 to Wednesday, 25 February 2015. As mentioned in a previous piece, Norway and the United States "have submitted a written request for the inclusion of the topic, "Intellectual Property and Innovation: Women And Innovation" (Source: WTO TRIPS Council-February 2015- Norway and the United States bring gender mainstreaming to the fore-Women and Innovation, http://keionline.org/node/2167).

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WTO Trade Policy Review of the United States: USTR deflects questions from India on compulsory licensing (December 2014)

Knowledge Ecology International - Sat, 21/02/2015 - 06:52

On 16 December 2014 and 18 December 2014, the World Trade Organization (WTO) undertook a trade policy review of the United States of America. All members of the WTO are subject to review under the Trade Policy Review Mechanism (TPRM).

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