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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.


The February 17, 2015 cover letter from CDC.

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.



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.


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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Human Rights Council Social Forum 2015: Intervention of Knowledge Ecology International

Knowledge Ecology International - Fri, 20/02/2015 - 15:06

20 February 2015

In accordance with Human Rights Council resolution A/HRC/RES/26/28, the Human Rights Council convened the 2015 Social Forum at the United Nations Palais des Nations in Geneva from 18-20, February 2015 with a focus on "access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, including best practices in this regard."

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Is it really worth pushing for EU medicine joint procurement?

Trans Atlantic Consumer Dialogue - Thu, 19/02/2015 - 11:40


Is it really worth pushing for? Access to medicines in Europe today & the Joint Procurement Agreement proposed by the European Commission.

Policy recommendations & summary of views on the Joint Procurement Agreement (henceforth JPA) following talks with European Commission officials from multiple DGs and numerous health attaches of member states.

by Yannis Natsis (19/02/2015)

In April 2014, the European Commission approved a joint procurement agreement to be used against serious cross-border health threats by taking advantage of “any counter-measures”. It built on the difficulties that EU member states encountered in purchasing vaccines for the 2009 H1N1 pandemic. The goal of the Commission was to design a very flexible tool that can be employed against all communicable diseases. To this end, the EC’s legal services reiterate that the list of 40+ communicable diseases under surveillance by the European Centre for Disease Control (ECDC) in Stockholm is not restrictive. This list includes all of the usual kids’ diseases along with HIV, Hep C and TB among others. Cancer is excluded as it is not a communicable disease. In other words, the scope of application has been expanded well beyond the pandemic vaccines to include all counter-measures.

The first real use of the JPA is underway and it is about the purchasing of protective equipment for people taking care of Ebola and other diseases. The process has already been launched as 4 member states –which is the minimum number of states required to activate the procedure- have already expressed interest.

Participation in any JPA is voluntary. The Commission anticipates that most member states will be on board the JPA within the next semester. Nevertheless, even if all member states sign on to the JPA, this does not mean that they will ever use it. The Commission notes that Belgium is the driving force while France, Spain and Italy have always been supportive of such initiatives. Germany was cautious at first because of the Lander system but now is on board too. The UK does not want to use the JPA for pandemic vaccines; however it acknowledges its potential on the rest of the counter-measures. The case of Poland is quite interesting. They do not want to be part of the JPA at all as back in 2009; they never bought the vaccine against H1N1 and in retrospect and taking into account that in the end there was no real pandemic, that decision was a political victory for them. That is why, now no Polish politician wants to be seen favorable to an initiative that was not beneficial. Nevertheless, Commission officials emphasize the fact that Poland back in 2009 was simply lucky as had there been a real public health crisis, the country would have been left without vaccines. They comment that the JPA can be instrumental in guaranteeing the supply, the access as well as the best price especially for smaller member states.

As for the French initiative on Sovaldi, they comment that at the very beginning, it was not even clear whether Hepatitis C fell within the scope of a possible JPA but now the legal services have spoken and it does. In the opinion of people from DG SANTE that we have spoken to, Sovaldi was not the ideal example to use the JPA to start with as a) there are several national sensitivities and differences, b) countries had already started sharing information on a bilateral basis using managed entry contracts and c) there will be alternative treatments on the market shortly and hence competition will play its game. This is probably one of the reasons why none of the eight member states that have originally stated they would be interested in using the JPA on Sovaldi ever submitted a formal request to the EC.

The Commission strongly defends (or at least DG SANTE does) the JPA and notes that the Council has nothing to do with it; it is only between the Commission and the member states. It is keen to keep the Council out of it all together by saying that member states’ health attaches “bring politics where there is no politics at all”. They remind that the JPA is considered by the Commission and most member states (with the exception of Spain, France and Italy; they view it as an international treaty requiring parliamentary ratification) as a mere budgetary implementing measure of Decision 1082/2013 on serious cross border threats to health i.e. a simple agreement.

A JPA works in the following manner: the Commission is in the driving seat of the process. It is mandated by the member states involved with a clear set of terms of reference. A steering committee composed of Commission and member states representatives heads each JPA. Member states instruct the Commission, set the red lines and define the specifications as to how the tenders will be assessed. Specifications are public, but offers are not. Tenders are evaluated by the Commission with the help of “independent evaluators nominated by participating member states”. Evaluation reports can be requested by those who participated but they are not public as such. The award decision is public and contract can be made public at a later stage. A market is awarded on the basis of predefined award criteria; the weighing of technical and financial characteristics of the tender is one of them and “best value for money” will be awarded more points than the others. Needless to mention, that a JPA means that all member states involved get the same price, the same product and the same contract.

Most EU member states robustly oppose the JPA –along with some DGs in the Commission itself- as designed by the Commission for the following reasons: 1) the Commission has no competence over these issues, 2) this is a Trojan horse for the Commission to gain access to the area of medicines and to expand its mandate on the area of health in general, 3) they have serious reservations over the leading role of the Commission; to put it bluntly they do not trust it at all in conducting negotiations  with pharmaceutical companies, 4) they support the view that there are no sufficient safeguards in place for the transparency and accountability, 5) they do not appreciate the fact that the Council is completely sidelined, 6) they believe that the Commission will act in obscurity and will be easily guided and manipulated by the pharmaceutical companies and 7) through JPAs pharma companies will enjoy a guaranteed volume and income. The fact that in the December 2014 Council Conclusions on Health, the original references to the JPA were removed from the final text is indicative of the mood in the Council against the JPA.

The Commission on the other hand is optimistic and committed to advocating for the JPA. It believes that it can be applied to medicines, for which several products exist on the market and have a marketing authorization. In their opinion, the high cost of new life-saving treatments and their impact on health systems’ sustainability will be a strong driver for the proliferation of future JPAs too.

Next steps

On the whole, the status quo is not conducive to promote the JPA as a main policy option to respond to the access to medicines problems in Europe today. Even so, several member states seem to encourage the option of pooled procurement through bilateral agreements. They view the centralized Commission-headed procedure with suspicion and caution but would be willing to examine the prospect of countries joining forces on an ad hoc basis. In principle, they agree that more countries united will lead to money-saving deals with pharmaceutical companies. The Commission replies that bilateral agreements are of course possible but comments that it will be difficult for the countries to define the terms of reference of such collaboration, whereas the JPA has all of the answers ready.

On our side, we can push for pooled procurement preferably through bilateral agreements as a way to achieve lower prices and weaken companies’ bargaining position. In all cases, our calls for joint purchases go hand in hand with a maximum degree of transparency and public scrutiny along with the need to buy medicines that have a proven added therapeutic value otherwise joint procurement can easily serve the pharmaceutical sector’s interests. 

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European Commission and Council´s new “Pharmish” terms on access to medicines

Trans Atlantic Consumer Dialogue - Wed, 18/02/2015 - 07:16


When “access” is not accessible, “transparency” is not transparent and “affordability” is not affordable
Last Wednesday evening at the Strasbourg plenary session many Members of the European Parliament voiced their demands for an effective European strategy for access to affordable life-saving medicines.


The debate was sparked by the outrageously abusive prices for treatments for Hepatitis C that affects 9 million Europeans. Some of the concrete proposals from liberal, green, socialist and leftist MEPs included initiatives on intellectual property rights, price capping, price transparency, new innovation models that de-link R and D costs from prices, joint procurement and competition policy.

But what was most surprising was the reaction of the European Commission and the Council represented by the Latvian Presidency of the EU. Their autistic reaction totally ignored the main objective of the debate: affordability. To understand how the European Commission and the Council of Ministers use a new language called “pharmish” I have started the following glossary. (for more technical references on please see: http://tacd-ip.org/archives/1303):
Glossary of European Commission and Council new “pharmish” terms


“Access to medicines”: Access to the market. “Timely access to market of innovative medicines”. This means shortening and simplifying the “regulatory barriers” (authorization, safety and efficacy testing, clinical trial requirements) and allowing some new very expensive medicines to be commercialized before finishing their normal regulatory evaluation afterwards through “adaptive pathways”. Here access means market access for “new” medicines not patient access for the majority of Europeans and their public health systems that cannot afford them.

“Availability”: Not available for most people. Make “available” new medicines. Give pharma EU public funds to research and develop “new, innovative medicines” (usually very expensive) with no strings attached with regards to affordability and the control over intellectual property rights. The Innovative Medicines Initiative (IMI) is one example of joint EU-Pharma initiatives (1.5 billion EU funds matched by Pharma´s opaque “in kind” contribution) that is often criticized for its lack of transparency and accountability. EU medical research funding does not set any social conditions.

“Pricing Transparency”: Only transparent for industry. No public transparency of medicine prices paid by Governments but increasing the hoops Governments must jump through to justify not buying high priced medicines or buying similar generic products instead. Tie the hands of EU member states trying to negotiate lower prices for medicines by legally mandating short deadlines for deciding prices paid to reimburse medicines. Prohibit re-assessment of efficacy and safety of medicines by EU member states.

“Differentiated prices”: Same prices but not any lower. Keeping prices from going down, less price transparency and restricting EU internal market to prevent “parallel trade”. Based on GDP to let the wealthier countries pay more for expensive medicines than poorer ones but Pharma freely establishes the first prices on the market. This is what already exists “de facto” in the EU. A strategy by the European Commission to prevent EU member states from negotiating prices that are “too low” for Pharma.

“Innovation”: Innovation is any new medicine on the market regardless of its therapeutic added value compared to existing medicines (to which they are rarely compared in clinical trials) and regardless of price. The more restrictions and delays for the entry of generic products onto the market, the more innovation. Whatever is protected by intellectual property rights, the more patents filed, the more innovation, The more market access of new products, more innovation. The longer the monopoly periods of “data exclusivity” and “supplementary patent certificates”, the more positive “innovation environment”. The lower the threshold is to qualify as “an innovative step” to justify granting a new patent monopoly, the more innovation. The less stringent regulation and authorization procedures (“barriers”) are on safety, efficacy and transparency, more innovation.

“Setting prices by health outcome”: This means justifying very high prices for new medicines on the basis of the theoretical “preventive savings” over time to a public health authorities in comparison with non-use of the medicine. This reasoning applied to other products would mean that street traffic light technology prices should take into account the cost of all the accidents if traffic lights were not installed at street corners.

“Health Technology Assessment” HTA: The evaluation of the cost-benefit analysis of new medicines before they are purchased by EU member state public health authorities. Something to be avoided, weakened and obstructed as they tend to be bad for industry growth (specially if it is independent and rigorous) . The European Commission discourages re-assessment of the therapeutic value of new medicines and is considering cutting funding for EU wide cooperation of HTAs.

“Joint Procurement”: A procedure established to centralize with the European Commission the pooling of procurement of medicines for a number of EU member states that has never been used to purchase medicines due to the lack of confidence of most EU member states in the independence from the pharmaceutical industry of the European Commission.

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Save the Date- 19 February 2015- Fire in the Blood- Screening co-sponsored by KEI/MSF-Access Campaign

Knowledge Ecology International - Sun, 15/02/2015 - 23:19

The Human Rights Council's 2015 Social Forum will take place from 18 February 2015 to 20 February 2015 at the Palais des Nations in Geneva, Switzerland.

As requested by the Council in the above-mentioned resolution, the 2015 Social Forum will focus on "access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, including best practices in this regard ". (Source: http://www.ohchr.org/EN/Issues/Poverty/SForum/Pages/SForum2015.aspx).

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EU & new medicines: added therapeutic value VS early access

Trans Atlantic Consumer Dialogue - Fri, 13/02/2015 - 11:25


Something (almost) revolutionary happened recently at the EU Council of Ministers but it remains to be seen how courageous the European Commission will be.

By Yannis Natsis

The European Commission is currently considering how to follow-up on the Employment, Social Policy, Health and Consumer affairs Council (EPSCO) Conclusions on “innovation for the benefit of patients” unanimously adopted in December 2014 under the Italian Presidency. Council conclusions reflect the positions of the governments of the 28 EU member states; are not legally binding but carry significant political weight. This 5-page document outlines the guidelines for the future priorities of the Council and the Commission and it includes several proposals that could be favorable to the positions of the civil society access to medicines movement. Of course, there are many that have seemingly been dictated by the industry for example clauses 35 a (active role in the decision-making process), and 32 (early access). Some of the most promising clauses are points 18 and 25 which highlight the high cost of medicines, clauses 29 & 40 which raise the issue of information exchange on prices and expenditure and the repeated references to the importance of Health Technology Assessment (henceforth HTA) mechanisms to evaluate the efficacy, safety and cost-benefit of a drug.

The most important and innovation-related clause by far is 35 (b) which reads “use existing relevant fora to reflect on whether criteria are needed to take account of added therapeutic value of new medicinal products in comparison with the existing ones for placing them on the market”. Indeed, this is a very welcome development as it has the potential to prevent products that have little or no added therapeutic value from coming onto the market. If elaborated further, it could signal an additional requirement upon pharmaceutical companies as they will have to prove not only the safety and efficacy but also the therapeutic advance in comparison to existing choices as opposed to present system that tends to only compare new products to placebo. In other words, they will need to demonstrate that the new medicine serves a purpose better than the existing alternatives on the market. Hence, it could prevent the proliferation of “me-too” products i.e. the majority of commercial-driven newly marketed so-called innovative medicines. This was defended by several member states who wish to protect their health budgets from the immoral prices demanded by the industry for some not so innovative new medicines. Based on the Conclusions, it is clear that the role of HTA bodies is growing and evolving in terms of pricing, reimbursement and assessment procedures and criteria. They play a key role in guaranteeing that the new drugs will perform better than the existing ones. This probably explains why HTA bodies are among the primary targets of the pharmaceutical industry and that the EC might be cutting financing for European coordination of HTAs.

The appropriate department of the European Commission, namely Directorate-General SANTE now has to examine how it will go about implementing these Conclusions in terms of presenting new pieces of legislation. The current Latvian Presidency of the Council has already made clear that it will leave the issue of medical innovation to the upcoming Luxembourgish and Dutch Presidencies, second half of 2015 and first half of 2016 respectively. However, already on February 17 2015, the senior level working group on public health of the Council will take place to discuss next steps. It is anticipated that Belgium, the Netherlands and Luxembourg will lead the process from now onwards.

On the other hand, the European Commission is keen on pushing for “the safe and timely access to medicines” as indicated by the name of the sub-group recently set up by its Human Pharmaceutical Committee. There is a similar trend at the Council which is reviewing the criteria for the authorization of medicines particularly with regard to pricing and reimbursement as well as the “early access tools” specifically conditional marketing authorization, accelerated assessment and market authorization under exceptional circumstances (also mentioned in point 6 of the Conclusions). At the same time, the European Medicines Agency (EMA) has been eagerly advocating the early approval of medicines as a way to ensure patients’ access to medicines through means such as the March 2014 “adaptive pathways” (formerly known as adaptive licensing) pilot project. This is an initiative hailed by the industry as it aims to improve and reduce the time for marketing and reimbursement decisions. It thus signals a bigger role for industry in the pre-licensing procedure and this puts the HTA bodies’ independence and right to assess the therapeutic added value at risk. There are also fears that speedier market authorization achieved through this process will have serious implications for patients’ health because they will rely on fewer clinical trial data.

All of the above; serve the diachronic pursuits of the industry which strives a) to place its products on the market as fast as possible at very high prices and b) have a place reserved around the negotiating table in relation to evaluation, pricing and reimbursement decisions.

2015 will not be a heavy year in terms of new EU legislation on health. The Commission and the Council will build on existing tools in sensitive areas such as HTA and market authorization. In this context, it is imperative that the debate on access to medicines is once again put on its true basis i.e. accessibility along with affordability, transparency and public scrutiny on all levels, public return for publicly-funded research, real innovation based on public health needs and proven therapeutic advance in comparison to existing medicines. In light of these troublesome developments, parts of the Council conclusions like the one on “the added therapeutic value of new medicinal products” become even more pertinent and should be underlined, defended and further strengthened. The new EU Health Commissioner should not miss the opportunity.

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