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D 4 March 2020    




The mission of the European Medicines Agency (EMA) is the efficacy testing and the ongoing supervision of medicines for the benefit of citizen health in the European Union. EMA main duties are related to the evaluation of applications by pharmaceutical companies for marketing authorization of medicines, monitoring medicines safety and provision of guidelines and information to health professionals and citizens. Following the marketing authorization by EMA, costs and reimbursement modalities are matters of decision by the national authorities of member states.

EMA is a big organization, with a budget of 330 million Euros and a staff of about 900. It is run by a Management Board, made by independent members not representing any government or organization. It has seven scientific committees and a number of working groups, in which thousands of experts participate. EMA works in collaboration with the regulatory authorities of member states, with the Directorate General for Health and Food Safety and other European agencies, such as the European Food Safety Authority and the European Centre on Disease Prevention and Control. Moreover, it maintains relationships with patient associations, health professionals and the academia. EMA has a mandate to operate in an independent, open and transparent way, by applying stringent criteria in its scientific evaluations. Its committees must provide recommendations on human and veterinary medicines based on a full and careful data assessment. Clear and unbiased information on characteristics of medicines and aspects of their use must be made public.

It is therefore clear to what extent EMA is important, because it is in charge of decisions guiding the use of medicines for a population of more than 500 million. No other agency of the same size plays a similar role in the world.

Unfortunately, in spite of the clear relevance of an institution like the EMA, the rules governing its functioning and their compliance with health protection goals have never been given a priority in the political agenda, even by the left wing forces. The spotlight on EMA has been briefly turned on just in relation to a minor and occasional occurrence, namely the choice of a new location due to the need to move away from London as a consequence of the forthcoming Brexit. This is even more remarkable because EMA is the subject of serious allegations concerning subordination to the pharmaceutical industry interests and lack of transparency, in sharp contrast with its mission.

The procedures for marketing authorization of medicines are far from being satisfactory and are aimed at fostering commercial interests at detriment of serious efficacy assessments. A number of recent surveys show that less than 10% of new medications authorized for marketing in Europe resent true advantages in comparison with already available products.

A recent survey by the French journal Prescrire showed that, out of 943 drugs approved by EMA between 2008 and 2017, only 23% offered clear benefits compared to those on the market.

The German Institute for Quality and Efficency in Health Care assessed the effects, in comparison to previous standard treatments, of 216 drugs that entered the market between 2011 and 2017. More than half did not show any proven added benefits in terms of mortality, morbidity and quality of life.

A careful analysis of data supporting the efficacy of 48 cancer drugs for 68 indications by EMA between 2009 and 2013, published in the British Medical Journal in 2017 concluded that less than 40% at 5-year follow-up were associated with a significant prolongation of survival and less than 15% with an improvement in quality of life. In few cases there was evidence for a survival gain coupled with a better quality of life. Moreover, quality of life was seldom assessed as a primary endpoint and this was a matter of concern, since these drugs were approved for the treatment of illnesses in which improvement in quality of life should be assessed in parallel of any clinical improvement. A modest survival gain should not be plagued by adverse events and toxicity.

A recent paper from the New England Journal of Medicine reported the data of an independent study confronting two antiplated drugs approved for use on cardiology. Although both were considered equally as effective on the basis of studies versus placebo, as requested by EMA authorization procedures, one of them showed significantly better results. It is worth noting that in Europe the patent of the more effective drug was expired, whereas the other one, more recent but less effective, was covered by patent and more expensive.

The above presented examples highlight the inadequate criteria applied by EMA to assess the studies supporting efficacy and safety of new medicines to be authorized for marketing.

Therefore, the pivotal criteria of quality, efficacy and safety used by EMA have to be revised, especially when considering that EMA restricted its evaluations of efficacy and safety to clinical study comparing an active drug with placebo.

A change in strategy is badly needed. Efficacy must be measured on hard outcome measures, such as survival and quality of life, not on surrogate ones. Comparisons must be made with the best treatments found effective for the same indications. This is the only way to assess the added therapeutic value of a new drug in terms of efficacy, tolerability and cost/benefits ratio. Comparisons with placebo must be restricted to indications for which no effective drugs are already available.

The design of the clinical studies to be assessed for the evaluation of efficacy and safety must be of superiority instead of non-inferiority, as it is the rule today, to avoid the marketing of products not representing true innovations with respect to those already available, but likely to increase drug expenditures and profits of pharmaceutical companies.

The two clinical trials presented to support the application for approval are currently promoted by the industries, thus favoring conflicts of interests. This cannot be accepted: a study must be realized by an independant non-profit agency, without links with the company requesting the authorization. The company has to make funds available to bear the study costs.

Data supporting applications for a drug approval cannot be kept confidential and must be made public. The entire process leading to the decision about marketing must be available for independent scrutiny.

Industrial secrecy and privacy of subjects involved in trial cannot be claimed to support confidentiality. Privacy of subjects can be guaranteed without hindering the availability of data.

So far EMA has not be ready to accept the criticisms raised on its procedures for marketing authorization, on the contrary it has been moving in the opposite direction, running the risk of reducing the scientific rigor through the introduction of a fast track pathway, thus ensuring to the companies a shorter time to get the approval, leaving to the member states authorities the task of further assessments. This could be accepted just to streamline the bureaucratic procedures, provided that the requirements about study design, goals and transparency of procedures will be respected.

The lack of transparency noticed in the management of study data is evident in serious shortcomings concerning the important function of monitoring the post-marketing use of medication and the provision of user-friendly information for citizens. Both aspects have to be improved and secured through the allocation of adequate resources.

In conclusion, there is room for a campaign aimed at proposing a radical change of the regulations governing the EMA functioning, in order to make EMA a suitable tool for the health protection of European citizens.

Angelo Barbato & Lucilla Tedeschi
European Network against privatization and commercialization of Health and Social protection, Italian branch
February 2020


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