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.

¿Regulatory Cooperation or Regulatory Co-optation?

Questions asked to top EU and US negotiators Ignacio Bercero and Dan Mullaney at TTIP stakeholders event on February 4th, 2014

Trojan horse TTIP

 

Is it smart? Is it fair and balanced? Will it chill future legislation in the EU? Can so much transatlantic policy analysis end up in paralysis?

 

After all the dust settles and many policy disagreements remain between the US and the EU, the permanent structures and mechanisms set up for transatlantic “regulatory cooperation”, as recently proposed by the EU, will be of the upmost importance. This “cooperation” can mould, inhibit and delay new laws on both sides of the Atlantic, adding a new filter or hoop to jump through for policymakers.

 

How will regulatory cooperation avoid creating a new channel for corporate, business lobbies that totally mismatch in resources, paid technical and legal expertise and personnel, way above and beyond what consumer and NGOs can offer to influence this EU-US cooperation? As pointed out in a recent Ombudsman report on the gross imbalance of existing EU expert groups,in favour of big business, How will you avoid this very unequal capacity of influencing legislation in the advisory structures of TTIP cooperation.

 

The scope is not clear: What are the sensitive areas, if any, that are excluded from regulatory cooperation? In the text proposal nothing is excluded. Will it include national and regional laws as well?

 

Since the proposal includes a whole slew of new procedures and structures (early warning, regulatory cooperation body, joint examination, ect…) Are we not creating a new bureaucratic leviathan? Is this the smart, agile legislation the EC is promoting? How can the existence of these new processes not have a negative impact on the sovereign democratic legislative role of the European Parliament?

 

One reason why Syriza won: the access to medicines crisis

by Yannis Natsis, TACD advocacy officer

Is there an access to medicines crisis in Greece? Yes, and if nothing changes radically, the worst is yet to come!!

This rather pessimistic note summarizes the state of public health in crisis-hit Greece as the country just elected a new government. Some overall macroeconomic figures may have improved but if one looks beyond the numbers, it is evident that the crisis is more present than ever. The public health sector has been particularly hit. It is true that in the pre-crisis era, important amounts of money were wasted in fraud and mismanagement as health is indeed a profitable business. The drastic horizontal spending cuts agreed and implemented in the context of the Troika-dictated policies have however created serious obstacles to peoples’ access to medicines and health services.

In Greece, health insurance is linked to one’s employment status. Since spring 2010 and the signing of the first memorandum of understanding with the country’s international lenders, the so-called Troika (the International Monetary Fund, the European Central Bank and the European Commission), unemployment skyrocketed to almost 30% in the general population and 60% among the youth. This means that over the past five years millions of people lost their jobs and more importantly lost their health coverage. There have been numerous public statements that put the number of the uninsured between 1.5 & 2.5 million in a country of 10,5 million. It is worth noting that national legislation guarantees some social protection for a maximum of two years following the end of one’s employment. But who are these millions of uninsured and what happens to them if they get sick? They mostly belong to the middle-class or what used to be the middle-class in the country; in other words, people in their 30s, 40s and 50s, SMEs’ owners, self-employed and others who were forced out of business while never reaching retirement age. It is important to remember that in many cases, losing their health coverage meant that their family members fell off the social safety net too. The younger generation is the second vast category of people who never managed to find employment and are regarded as chronically unemployed. Ironically, for the moment, the latter are better off thanks to their young age and good health. This probably explains why the consequences of the crisis on public health are not fully felt yet. There are nonetheless numerous worrisome signs that lead to the conclusion that the status quo resembles a time bomb waiting to explode.

Experts and people from the field such as pharmacists, patient groups, doctors, civil society stakeholders who have set up social clinics & pharmacies -another symptom of the crisis- as well as several hospital directors concur that 2014 was the year where the number of uninsured patients went up dramatically. This adds up if ones take into account that the aforementioned 2-year social safety net has by now lapsed. In the meantime, data collected by social clinics and pharmacies point to the fact that the health conditions they are dealing with are becoming more and more serious. Even patients with advanced cancer seek their help as they cannot afford their treatments anymore. This brings us to one of the cores of the access to medicines problem in Greece today: patients are increasingly becoming their own doctors, self-managing their condition and selecting treatments based on what they can afford and not what is right for them. This is the case not only for the uninsured but also for those who still enjoy some sort of social coverage; for example the pensioners with their considerably reduced income. This category includes all those affected by the significantly increased co-payment percentages and out of pocket expenditure. Moreover, social clinics are reporting numerous cases of both uninsured and insured patients whose health has worsened because of this treatment self-management. These policies contribute to worsening health conditions on one hand and on the other hand; higher cost for the public health system which will eventually be forced to deal with more serious health conditions.

But what happens to an uninsured person who gets sick or suffers from a chronic disease in Greece today? In June 2014, under growing pressure the government came up with a long overdue ministerial decision to guarantee that no uninsured will be left without health coverage. In essence, this decision puts the responsibility squarely on the public hospitals. It foresees the establishment of a hospital committee that will examine on a case by case basis whether a patient falls under the category of “uninsured” and can thus be hospitalized and benefit from all the services for free. It all sounds very good on paper but several state hospital directors already complain and emphasize that the reality on the ground is very different as: a) the procedure is heavily bureaucratic and time-consuming making it practically impossible for the uninsured to gain access to the treatments they need, b) red-tape always discourages adherence; not to mention c) every public hospital has a very specific budget and cannot bear the additional cost. It is therefore not surprising that patients choose to visit the hospitals’ emergency care units where treatment cannot be denied and is provided irrespective of one’s insurance status. A similar trend has been well documented in Spain.

According to the OECD, health spending in Greece has dropped in each of the years since 2009, driven by a sharp reduction in public spending as part of government-wide efforts to reduce the large budgetary deficit. In 2015, state pharmaceutical spending is capped at 2bn euro or 1% of the GDP (it stood at almost 6 bn in 2008).

The typical line of argumentation used by Greek government and Troika officials in responding to the access to medicines concerns is that there is no statistical data and most stories are based on anecdotal information. This has paved the way for them to embark on a denialism campaign claiming that the storm is abiding and the crisis fades away. Clearly, this is not true.

There are some short-term, medium-term and long-term options that the new government can implement so as to effectively address the access to medicines crisis the country faces. Firstly, it should strive for further price reductions with an emphasis on expensive life-saving treatments for chronic diseases such as cancer, Hepatitis C, HIV, diabetes and others. It is a common secret that the pharmaceutical industry is charging immoral prices for medicines that are not always innovative. Secondly, it will have to guarantee transparency and unconditional accountability on all levels of policy-making in the public health sector especially concerning pricing & reimbursement policies. To this end, it would be worthwhile to publish detailed information on state pharmaceutical expenditure (both in volume & value). Moreover, since the start of the crisis, there have been efforts to increase the use of generics in the country. These efforts will have to be strengthened as a healthy generics competition leads to affordable treatments for more patients. At the same time, public authorities ought to inform and reassure public opinion about the quality and safety of generics. Health policies particularly with regards to the pharmaceutical expenditure should be dictated by comprehensive impact-assessment studies along with health indicators taking into account the real needs of patients as well as the sustainability of the public health system. It is important to note that new medicines should be evaluated based on their real added therapeutic value. Once more; a maximum degree of public scrutiny needs to be ensured during the negotiations with the pharmaceutical industry. Patient engagement in decision-making bodies such as the national medicines organization (EOF) is another key parameter and common practice in many European states. The next government will have to reexamine the increases in the co-payment percentages that caused the damaging for patients treatment self-management. Keeping in mind that unemployment does not show any sign of being significantly lower in the near future, it is imperative that the Greek government shifts away from the current employment-dependent health coverage system towards a new national insurance scheme that will guarantee access to medicines and health services for everyone.

Additionally, the Greek government could explore the possibility of using the tools offered by international trade rules i.e. the TRIPS flexibilities and price controls such as compulsory licensing in order to enable the breaking of the license, asking other laboratories to develop the medicine and reduce its price by means of generics competition.

On the European level, the future Greek government should join forces with its European partners in questioning the current patent-based model of medical innovation (development of new drugs) and pricing which is the root cause of the problems most countries are faced with. Numerous public health systems cannot afford the exorbitant prices that pharmaceutical companies are demanding and patients are left without their medicines. It is a matter of political will and determination; the EU should allow for the development of alternative mechanisms to stimulate medical innovation such as patent pooling & equitable licensing, open data, collaborative data sharing and innovation prizes to name a few. This is a praiseworthy painstaking long-term objective and requires collective action at the EU Council level. Furthermore, more public investment is necessary as public budgets dedicated to health are rapidly declining across the Union. It is oxymoron that most medical research is publicly funded, yet the question to ask is what do we get in return? EU investment should be with strings attached in transparency, affordability and access.

Even if health does not fall under EU competence, there is ample space for governments to define the parameters of European research and innovation, rules of transparency, intellectual property rules enforcement and many other areas at an EU scale. Governments in Europe today find themselves in a far weaker place than pharmaceutical companies who benefit from the obscurity that prevails in the sector and is conducive to dealings under the counter. To this end, it is worthwhile examining the prospect of activating the joint procurement mechanism in order to maximize states’ negotiating capacity towards the pharmaceutical industries.

Last but not least, Greek patient groups and civil society have a key role to play. They should not be taken for granted as simple solidarity-support mechanisms that can substitute state health services. Should this volunteer movement develop into a parallel health system, this will be a major step backwards for the country. On the contrary, these much-needed organisations should invest in their advocacy capacity. They should aim to foster social dialogue among stakeholders (pharmacists, doctors, pharma industry) and shape policy-making while striving for the highest degree of transparency and public scrutiny in the Greek public life. To this end, it is essential that they prioritise as well as elaborate on concrete policy asks and recommendations. This way they can fulfill their potential and help the newly elected government move in the right direction.

Policy makers in Greece and in the EU need to show a lot more political will in facing the worsening access to health-care crisis. Let´s all hope that the worst in not yet to come.

Spanish Hepatitis C Patients Petition European Parliament

Petition to the European Parliament “For a European Plan for against Hepatitis C” presented by “Plataforma de Afectados por la Hepatitis C”(Spain)

 

 

Mario Cortes Morales, Spanish citizen, in representation of the “Plataforma de afectados por la Hepatitis C” (Platform of people affected by hepatitis C), presents this petition before the European Parliament.

 

Taking note of written declaration 87/2006 presented by MEPs Jolanta Dickute, John Bowis, Stephen Hughes, Frederique Ries and Thomas Ulmer concerning the need of the EU to combat Hepatitis C and to help provide treatment for those affected, which was approved by the majority of the European Parliament and was published in “Approved Texts” of the session 29.03.2007,

 

Considering that according to estimations over nine million citizens and residents in the EU are affected by hepatitis C and that every year there are thousands of deaths due to this illness,

 

Taking into account that the European Union does not have direct competences for the financing of public health nor the setting of medicine prices but considering that the EU does coordinate a voluntary system of EU member states that establishes reference prices for medicines and that other EU competences do affect drug prices of Hepatitis C treatments.

 

Considering that the European Union has legal competences over intellectual property policies, international trade, scientific research and innovation, the public debt of EU member states, the approval of new medicines, the internal market, clinical trial and price transparency, public procurement law and competition rules, among other norms that affect the price and access to Hepatitis C medicines,

 

And considering that access to health-care and the right to life are two fundamental rights defended by the European Union,

 

Requests the presentation of a European Plan against Hepatitis C that includes the coordination on the part of the European Commission of policies of joint procurement of affordable Hepatitis C treatments among EU member states.

 

Demands that the European Commission, the Council and the European Parliament present concrete policy proposals and flexible changes in EU legislation concerning intellectual property with the objective of encouraging the rapid entry into the european market, either from European production or importation, of affordable generic versions of the most effective and safe therapies for all EU citizens and residents affected by Hepatitis C.

 

Requests the creation of an EU emergency health-care rescue fund for people affected by Hepatitis C en EU member states affected by public spending austerity measures mandated by the EU and askes the European Commission to carry out a health impact evaluation of health-care cutbacks with special reference to their impact on Hepatitis C patients.

 

Asks the European Commission to carry out a study and to collect public-health data concerning the prevalence of Hepatitis C in the EU.

 

Requests the adoption of legal EU norms for the public transparency of the prices paid for medicines in the public procurement of medicines.

 

Demands that the European Commission opens up an investigation of the possible violation of EU competition law and public procurement law in the marketing and purchasing of high-priced new medicines for treatment of Hepatitis C.

 

Asks the European Commission to finance econometric studies on the possible future scenarios concerning the economic and health system viability of the erradication of Hepatitis C in the European Union.

 

Requests that the European Commission adopts a series of recommendations of best practices for EU member states and the European health-care community for the treatment and cure of Hepatitis C.

 

Asks the European Commission and the Council of Member States to propose a series of measures in the areas of research, financing and best practices to guarantee the early detection and diagnosis of Hepatitis C.

 

Requests that the Horizon 2020 programme includes an innovation inducement prize for the production of a single-dose treatment for Hepatitis C that could enter the EU market as a generic medicine at an affordable price for the large majority of European patients by means of a non-exclusive, socially responsible intellectual property license.

 

Asks that all research studies financed by the Horizon 2020 programme related to Hepatitis C be guided by the rules mandated by the pilot programmes for “open data”.

 

 

Bruselas, 21 de enero de 2015

 

 

Five poor excuses used to block EU Ratification Marrakesh Treaty

blind girl

 

The Marrakesh Treaty was agreed in June, 2013. Now we are well into 2015 and the EU still has no plan on how to ratify the Treaty. While many other countries have either ratified or, at least, made progress to that end, the EU Council is not moving at all toward ratification. This is in total contradiction of the EU´s legal obligations with the UN Convention on the Rights of Persons with Disabilities.

 

Here are a few of the poor excuses being used to stall, delay and block EU ratification.

 

  1. It is not EU competence”It clearly is. Both Commission and Council legal services say it is. Here are the legal arguments given by the European Commission in its request for ratification:

    Finally, Article 6 of Directive 2001/29/EC provides comprehensive legal protection for

technological measures used by right holders and Article 6(4) provides that Member States

must ensure that beneficiaries of certain exceptions or limitations benefit from those

exceptions where technological protection measures are in place, in the absence of voluntary

agreements. Articles 3, 4, 7, 10 and 11 of the Treaty affect these provisions of EU law.

As a result, it is considered that:

a) the cross-border exchange of accessible-format copies with third countries is a predominant

element of the Treaty, therefore its relevant articles fall under the common

commercial policy (Article 207 TFEU); and

b) the articles of the Treaty on mandatory exceptions or limitations fall within the scope of

EU law, affect or alter the scope of the common rules, namely those in Directive

2001/29/EC and in any event are within an area which is already largely covered by

EU rules (Article 114 TFEU)8.

The Commission is therefore submitting a proposal for a Council Decision on the conclusion

of the Treaty. In accordance with Article 218(6)(a)(v) of the TFEU, the European Parliament

has to give its consent before the Decision is adopted.”

  1. Mixed competence ratification can be just as quick as EU competence”This is totally false because until each and every EU member state ratifies(often through national parliaments), the EU cannot ratify and implement the Treaty. Until all ratify, none have ratified. This will probably take many years and maybe never be completed.
  2. We have to wait for the new EU Copyright Directive”This is not necessary because exceptions for disabilities is already foreseen in the current Information Society Directive. If, in the unlikely case, some small legal modifications in EU law are needed, this can be done fairly quickly by means of a narrow, pinpointed legislative procedure.
  3. We have to first have national laws ready for implementation”This is not how national implementation of EU law usually works. First, the EU approves its laws and afterwards the EU member states are given a time period for national “transposition” of the new legal framework.
  4. Allowing EU competence will be a dangerous precedent for other treaties”The Marrakesh Treaty is based on international human rights obligations and is a very special case that affects people with disabilities. It should not be mixed up with other political or economic questions that are of a very different nature.
  5. If it is EU competence it will only count as 1 ratification instead of 28”More than 20 countries (the number needed for the Treaty to go into effect) around the world have either ratified or have started the procedures for ratification. What is most important is that the large proportion of accessible-formatted books in the world that are in EU member states. These books need to be part of the cross-border exchange mechanisms of treaty to make it meaningful for visually impaired persons around the world.