Adapting medicines to the market or to patients’ needs?

By Yannis Natsis, 22 April 2015

One has to analyse the future landscape and challenges that the European pharmaceutical industry is facing to better comprehend the political developments in medicines unfolding at the moment on the EU level. According to the WHO, the part of European medicines in global pharmaceutical sales is steadily decreasing. It is anticipated that by 2016 Europe will account for just 18% of global pharmaceutical spending – down from 24% in 2011 – with emerging markets (including Brazil, China, Mexico and South Africa) anticipated to account for 30% and the United States of America for 31% of market share.

In other words, the pharmaceutical industry is under pressure in Europe but that does not seem to stop them from imposing high prices on their products. As a result, the issue of high prices of medicines has been put on the European agenda for good since 2014 and the Sovaldi crisis. EU countries irrespective of whether they are in crisis or not, wish to lower medicine prices simply because they cannot afford them and they know for a fact that many more expensive products are on their way.

High prices of medicines & the Dutch-Belgian initiative on joint negotiations with pharma: a preliminary evaluation

This is at the core of the recent Belgian-Dutch initiative which seeks to obtain significant price reductions by joining forces in the negotiations with pharmaceutical companies. This initiative is particularly pertinent in light of the upcoming Dutch Presidency of the EU during the first half of 2016. As clarified, they intend to negotiate jointly but not to purchase medicines together. In other words, they want to 1) set a single price together, 2) create a precedent for further EU coordination and 3) use this as a template on how to deal with expensive innovative treatments namely on Hep C, rare diseases and orphan drugs.

It remains to be seen what the reaction of the industry will be but based on what we have seen before, industry is usually “allergic” towards any attempt to establish some sort of a single price or to open up the negotiation process by means of some form of bilateral or multilateral cooperation. The thinking behind this proposal is that industry will be forced to accept lower prices because countries will get together.

But what is the added value of this Belgian-Dutch initiative in comparison to current reality whereby individual member states bargain with pharmaceutical companies in secret and in the end, manage to get lower prices on their own? With Sovaldi, for instance, since its release EU countries reached deals for “as low as” 13.000 euro per treatment per patient down from the initial 60.000 euro price tag. The answer is simple: The Belgians and the Dutch are confident that they will be able to achieve even lower prices than that through joint negotiations. So far, so good but it gets more complicated.

What is the trade-off for industry and how does this fit in its strategy for the future?

Firstly, it guarantees market access for the latest treatments which is a top priority for pharma. Speedy access to medicines via quick market approval and the respective pricing and reimbursement coverage is the main theme in Brussels today heavily promoted by the European Pharmaceutical Association (EFPIA) but also by numerous patient groups. Secondly, it guarantees volume i.e. countries offer more commercial scale to companies in return for lower prices and thirdly and most importantly, companies push the legislator towards a more flexible market access & pricing and reimbursement framework in the EU.

Paradigm shift: from safety to early market access

This is where it gets tricky. The view that prevails in some member states today is that the EU framework on medicines is too rigid and has to become more flexible in line with the latest technological developments. They claim that safety is of utmost concern but stress that “maybe we have gone too far in pushing for safety to the extent that we stifle access to innovation”. This adds to the opinion that there is an overestimation of what can be achieved with regulatory instruments. Additionally, they argue that much of the regulation is old and from their perspective it has become too complex, too detailed and with too much focus on procedures instead of real issues. They stress that it is imperative to strike a new balance between patient safety and quicker access for patients to innovations.

The recent Belgian-Dutch announcement builds on this perceived need for a “new balance” and is only part of the bigger puzzle to gradually redesign the entire model of drug authorization and marketing in Europe. This is evident mostly through the European Medicines Agency (EMA) pilot projects on adaptive pathways (henceforth AL). We have written before that AL seeks to completely change the way we think of drug development and market approval with potentially very negative consequences on public health.

Adaptive pathways & the early access debate

There is an obsession with getting new medicines on to the market without considering if they offer any substantial therapeutic advance in comparison to existing drugs on the market. This is something crucial completely missing from the debate. Patient groups are often misled to believe that new medicines automatically equal better medicines; although, this is repeatedly proven wrong by many independent reviews such as Prescrire and the Cochrane Collaboration. On one hand, it is understandable to a certain extent why patient associations depending on the disease they represent, offer their unconditional support to initiatives such as adaptive pathways. What is worrisome on the other hand is that DG SANTE, what would be the equivalent of the Ministry of Health in the European Commission downplays importance of adaptive licensing and simply refers to it as a learning process, with low-scale pilot projects launched independently by the EMA. One only has to look at EFPIA´s website to conclude that the adaptive pathways project is by no means a small scale initiative. EFPIA names it as one of the main themes during its upcoming annual conference and describes adaptive pathways as “flexible development and access pathways within the current regulatory framework that balance early patient access, public health and societal benefits”. It explains that “it starts with an early authorisation of a product focused on a well-defined and targeted population with a clear safety and efficacy profile”.

Concerns over adaptive pathways

The question is why AL is required in the first place when there are tested fast-track regulatory mechanisms (conditional marketing, compassionate use and accelerated assessment) already in place that guarantee patients’ timely access to drugs. These instruments provide controlled patient access without having exhaustive evidence available at the time of the introduction but these approvals are subject to further work to substantiate the value of the product once in use. This means that the system already acknowledges the need to live with a limited degree of certainty. Moreover, there is no doubt that the existing early access tools can be further improved. Nonetheless, the aim of AL is to provide even earlier and quicker access to new medicines.

Here is where the problems start. This will require systems capable of responding to outcomes, including negative findings since it is based on accepting even more uncertainty. It must be noted that numerous regulatory systems do not operate in this way and serious adaptations will be required. Most importantly, delisting a new medicine, should it provide little value at the requested price is currently not a widespread option due to political and financial reasons. It is a well-established fact that once a medicine is on the market, it becomes far more difficult to monitor and control it let alone to withdraw it. It would take two incredibly important variables that cannot be taken from granted: a) political will and b) the governance capacity to make it happen. Furthermore, the scope of implementation of the adaptive pathways model is not clear. There are suspicions that once it gains speed it will not only be limited to “unmet medical need”. Besides, there is a lot of debate on what constitutes “unmet medical need”.

But adaptive licensing is not only about quick access. It is something much broader as it is synonymous with the life-span approach to medicines. As explained in my blog entry Pharma is moving fast: What is coming up in pharmaceuticals in Europe, adaptive pathways envisages an alignment of the regulatory environment with the reimbursement criteria so as to enable early approval and most notably coverage of a new product for an initially limited treatment population. These products are usually premium-priced drugs; that explains why healthcare payers are quite cautious. They see it –and rightly so- as another way for industry to get its products on the market and to be reimbursed. Industry has made it clear that they do not appreciate the current pricing and reimbursement system because a) there is a lot of divergence due to national competence, b) it is unpredictable as pricing & reimbursement decisions are mostly political decisions and c) of the increased evidence requirements that HTA organizations or payers put forward as additional gatekeepers. That is why adaptive pathways puts a lot of emphasis on early dialogues, horizon scanning, parallel scientific advice and criteria convergence.

In this whole debate, industry pushes patients to the forefront and encourages them to demand access to the new treatments and of course, to have them reimbursed by health authorities. Patients need to be fully aware of the risks that go with accepting increased “uncertainty” which is an integral element of adaptive licensing. It is hard to believe how patient safety will not be undermined when timetables are squeezed and much less clinical trial data is required. A shorter time to the market would possibly be beneficial both for the industry as well as for the patients only as long as sufficient safeguards are in place. If not, all this could lead to an unacceptable lowering of evidence requirements and higher risks for public health.

Greek Health Minister calls for public interest pharma model

 

Main speaking points of the Greek Health Minister Mr. Panayotis KOUROUMPLIS at the informal EU Health Ministers’ Council in Riga, Latvia (20-21 April 2015)1

  1. The sustainability of the public health system accessible to all is a shared goal. Therefore, health expenditure should neither be demonized nor be subjected to horizontal cuts without previous consideration.

  2. Over the past years, under the guidance of the Troika, dramatic cuts have been imposed on Greece without any impact assessment. That is why; today, there is a real humanitarian crisis affecting everyone living in the country.

  3. The astronomical cost of new treatments especially for chronic conditions is certainly not viable not only for Greece but for many other EU countries too, whether they are in crisis or not.

  4. In many cases, the cost of new treatments does not reflect real medical innovation but speculation on the part of pharmaceutical companies.

  5. According to the December 2014 Council Conclusions, the market approval and pricing of new medicines should take into account their real added therapeutic value compared to existing options on the market.

  6. Furthermore, he called on member states to consider joint negotiations and procurement of medicines (for example cancer & HIV treatments). In his view, this will have considerable positive effects on the public budget as well as on European citizens’ health.

  7. This debate is timely as the European Commission is considering improvements of the current approval, pricing and reimbursement system. The guiding principle in these discussions should be the respect of the national competence and the guarantee of the integrity and independence of regulatory institutions such as the European Medicines Agency (EMA). To this end, there must be sufficient safeguards in place to make sure that the regulated i.e. major pharmaceutical companies are not in a position to determine the terms of their regulation.

  8. He called on the EU to build on the May 2010 Conclusions which acknowledged the need to dissociate/delink the price of new medicines from the cost of research & development. He reiterated that the EU can help decisively by conducting pilot projects and feasibility studies on the development of alternative models of medical innovation. In his view, this will lead to truly innovative therapies that effectively address the genuine needs of patients and are accessible by all. These studies will offer the opportunity to move away from the current model of medical innovation that favours monopolies and results in unaffordable treatments.

  9. Finally, the EU must guarantee the public return of investment in research & development of new medicines by means of strict conditionality attached to public funds going into medical R&D.

1 Translation from Greek based on speech published at http://www.kouroumplis.gr/mme/article/1207 (accessed 21 April 2015).

Write to your MEP to speak out for EU Marrakesh Treaty Ratification

Dear MEP:

I would like to call your attention to the plenary debate on the ratification of the Marrakesh Treaty that will take place next session in Strasbourg, probably on April 29th. We would like to ask you to request speaking time or to participate through the “catch the eye” procedure to support the EU´s swift ratification of the Marrakesh Treaty. This would back the demands of millions of blind persons and other visually impaired people in favor of the right to access to reading material in accessible formats.

Please find below a short explanation and suggested speaking points for the debate.

Thank you in advance for your support,

European Blind Union

Speaking points for MEPs for Marrakesh Treaty debate in the European Parliament: Please support in plenary the right to read of blind and visually-impaired persons!

The situation:

Since the international agreement reached on the Marrakesh Treaty nearly two years ago it is not acceptable that the EU and its member states have yet to make any progress toward the ratification and implementation of this important international human rights tool for the access to culture of millions of blind and visually impaired persons. . We are deeply concerned and disappointed that due to a lack of consensus building, technical-legal commitment and political will on the part of EU member states time has been unduly wasted.

Why we need the Treaty?

We are suffering a “book famine” because fewer than 5 percent of the books published in Europe are available in a format which is accessible for blind and low vision readers while the books that are available cannot be shared across borders in Europe and the rest of the world where fewer than 1% of the books published are available for visually-impaired persons. This enormous lack of accessible mother tongue and foreign language literature deprives blind and partially sighted people of their right to education, information and social participation. EU ratification of the Marrakesh Treaty will help overcome the existing barriers of national copyright laws in order to facilitate the cross-border flow of specially formatted works for visually-impaired persons.

What the European Blind Union asks for:

The European Blind Union strongly opposes the attempt by the Latvian Council Presidency to suspend the ratification process by the EU of the Marrakesh Treaty. This would greatly delay the effective entry in force of the Treaty and the facilitation of access to culture of millions of blind persons in Europe and around the world.

The European Blind Union rejects any attempt to include the Marrakesh Treaty in the general debate about the future of copyright in the EU. Former Commissioner Michel Barnier committed himself publicly on behalf of the European Commission for Marrakesh ratification not to be mixed up with the EU´s new copyright framework. This Treaty is a specific issue of basic human rights for persons with disabilities that should not be delayed for many years by mixing it up with very different issues.

If the Council is convinced that new legislation is needed for implementation(though Council and Commission legal services now do not agree) the EBU asks the Council to present a written position on the legislative changes it deems necessary to EU legislation so as to avoid unnecessary disagreements and delays in the future. These should be drafted in close consultation with blind person’s representatives and their organizations to assure that the objectives of the Marrakesh Treaty are not weakened or changed in anyway by new EU legislation. Even if legal changes are needed later, the EBU asks the EU and its member states to proceed now to ratify the Treaty.
The EBU calls upon the Commission and the Council to adopt a time table which indicates the time frame for the ratification and implementation of the Marrakech treaty.

The EBU asks the European Parliament, the Commission and the Council to establish three-way informal “trialogue” consultations to reach an agreement on the swiftest way of assuring ratification and implementation of the Treaty.

Marrakesh in the EU: facing the excuses and delay tactics after Council statement

What the Council Statement on Marrakech says:

Council Statement: http://www.statewatch.org/news/2015/apr/eu-council-marrakesh-treaty-guidance-7321-15.pdf

Two separate issues are dealt with: how to put Marrakesh into EU law and how to ratify the Treaty

We are facing two issues put forth by EU Member States: “the appropriate sequence of the implementation of the Marrakesh Treaty” and “the appropriate legal basis for the decision, in conjunction with the question of competence (exclusive versus shared)” Even if there are first legislative changes in copyright law for Marrakesh, it is still not at all clear that EU Member States will want to ratify as exclusive EU competence.

As opposed to the Commission the Council´s position is that the Treaty cannot be implemented without changes in EU legislation. The Council presents no legal arguments for its position while the Commission has. It criticizes the Commission harshly for not presenting a legislative proposal in last year and a half and for presenting “vague proposals that lack legal certainty.” This is a blame game, a political ping-pong that wastes time and diverts attention from ratification.

Surprisingly, the Council admits that it could take the decision to ratify the Treaty now and to deposit the ratification decision in WIPO once “legal implementation” is done (but prefers to have new legislation first): “even if the Council adopts the Decision on the conclusion of the Marrakesh Treaty on behalf of the European Union, it would not be possible to deposit the relevant instruments of ratification (and thus finalise the conclusion of the Marrakesh Treaty by the European Union) until the internal EU legal framework has been adjusted accordingly.”

Competence issue: The Council admits that its own legal service agrees with the Commission that it is “EU exclusive competence” Logically this also means that the Council legal service also implies that there is no need for new legislation since the basis of EU exclusive competence is that it is already covered  by EU law.

The Council says some member states want EU Treaty Article 19.1 (to combat discrimination) to also be used as a legal basis for ratification.

Finally, the Council asks the Commission to suspend the ratification request and asks to Commission to present a legislative proposal to adapt Marrakesh to EU law.
Possible Responses for the debate in the European Parliament Plenary(last week of April):

Express our profound dissatisfaction that over a year and a half time has been lost for access to culture for the visually-impaired due to a lack of consensus building, technical-legal commitment and political will on the part of EU member states. This expresses a lack of sensitivity of the needs of blind and visually impaired persons. We do not want a blame game between Council and Commission but concrete, swift progress toward Treaty ratification.
Demand that the Council presents a written position on the legislative changes it deems necessary to EU legislation so as to avoid unnecessary disagreements and delays in the future. These should be drafted in close consultation with blind persons representatives and their organizations to assure that the objectives of the Marrakesh Treaty are not weakened or changed in anyway by new EU legislation.
Reject the suspension of the Ratification process as proposed by the Council and reject inserting Marrakesh legal implementation in the general copyright debate.
Ask the European Parliament, the Commission and the Council to have three-way informal consultations to reach an agreement on the swiftest way of assuring ratification and implementation.
Demand that the Council and the Commission adopt a timetable for the ratification/implementation process.

NOTE: Please contact your MEPs.  Any member of the European Parliament from any country or political group can participate in this plenary debate. Even if he/she does not have official speaking time, he or she can ask to speak briefly from the floor of the plenary debate by the “catch the eye” process.

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

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.

Guessing for medicine patents, TTIP and ISDS in action

 

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>


Is it really worth pushing for EU medicine joint procurement?

 

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. 

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

 

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.

http://www.europarl.europa.eu/sides/getVod.do?mode=unit&language=EN&vodId=1423689420470

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.

EU & new medicines: added therapeutic value VS early access

 

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.

Commission and Council delay EU ratification of the Marrakesh Treaty

The EU´s Council Working Group on copyright has succeeded in blocking  progress toward swift EU ratification of the global right-to-read Marrakesh Treaty that seeks to benefit millions of blind and other visually impaired people around the world. Quick ratification had been publicly promised by Commissioner Vice-President Ansip. The Council Working Group on Copyright, which for years opposed a binding international treaty for an exception to copyright for the visually impaired, is mainly made up of national copyright office officials whose obvious first concern is to defend intellectual property laws and not fulfill the EU´s human rights obligations under the UN Convention on the Rights of Disabled Persons. Why is the Commission obediently following the narrow interests of national copyright offices instead of pushing this issue up to a higher political level in the Council where broader concerns will be taken into account?

The European Commission now will consider possible changes to first harmonize EU law on exceptions to copyright for the visually-impaired before considering ratification of the Marrakech Treaty. It has been decided that the Commissio will prepere a “non-paper” to test the waters and open, yet again, a new debate on how to proceed. Back to square one!

This means that even before considering ratification, EU member states insist on integrating the elements of Marrakesh into future EU copyright law. This is exactly the opposite of what had been promised to European Blind organizations by former Commissioner Barnier. Something is very unsatisfactory and surprising in this whole process. The Commission does not usually propose actions to be taken by the Council when it knows that nearly all member states are against it. As well, to start the process with a “non-paper”(no legal commitment nor concrete proposal) is a non-starter as it suggests a long process to even reach the stage of legislation. It could reflect a lack of political will to make this a swift process for a very minor modification of existing EU law on copyright (Information Society Directive 2001/29) and it could mean the desire on the part of the Commission and Council to delay Marrakesh until the whole new EU copyright framework is in place in 3 to 5 years time.

The ratification and implementation of the Marrakesh Treaty will mean facilitating the access to culture of tens of millions of people by making much more accessible the cross-border shipment of books specially formatted for the visually-impaired. What is also at stake are the leadership credentials of new digital agenda Commissioners Ansip and Oettinger whose declared objectives have included copyright reform for the benefit of disabled persons.