EU Pharma Strategy too focussed on needs of manufacturers, rather than patients, says Michèle Rivasi

Greens/EFA MEP says European Commission’s long overdue pharmaceutical strategy ‘fails to address’ EU’s true health problems, including drug shortages.
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By Michèle Rivasi

Michèle Rivasi (FR, Greens/EFA) is a member of Parliament’s Special Committee on Beating Cancer

09 Dec 2020

In Belgium, people suffering from chronic inflammatory bowel disease face a double punishment. On the one hand, the excruciating pain caused by inflammation of their digestive system; on the other, the near impossibility of accessing sufficient quantities of crucial drugs to treat their disease. It seems hard to believe that now, in the 21st century, this is the case in Belgium.

Yet it is the reality of the plea for help I received from patient associations and hospital doctors in October in the European Parliament. In theory, the various remedies for treating chronic inflammation of the intestine are available in Belgium at very low prices - among the cheapest in Europe.

Yet the existing supply tensions that many professionals could already see on these treatments has now turned - since the COVID-19 health crisis - into a prolonged, generalised shortage. Some pharmaceutical companies - Ferring and Falk laboratories in particular - have actually ceased production of their products for the Belgian market. Why? Because any new production “would be at a loss”.

“The search for margins at all costs has led to a shortage of essential drugs in developing countries”

Other products are not available on the Belgian market, although they can be found in neighbouring European countries, but at higher prices. Some of these treatments are delivered to Belgian wholesalers in sufficient quantities, but these intermediaries prefer to resell most of them outside Belgium, seeking more lucrative returns.

This crisis in access to medicines seen in Belgium shows one thing: that the current system makes no sense. The principle of parallel trade in medicines - authorised by the WTO to be able to obtain remedies at prices more accessible to the patient - and limited in Europe to the borders of the common market, has been perverted by the market.

The search for margins at all costs has led to a shortage of essential drugs in developing countries. The alarm bells raised by both patients’ associations and specialists in chronic inflammatory bowel diseases are unfortunately not uncommon.

In recent years, the situation has worsened dramatically. So why wait to respond to the shortage of medicines? In France, the overall number of supply disruptions has tripled in three years, from 407 in 2016 to more than 1200 last year. It is also six times higher than it was four years ago.

Sadly, we could easily find more examples. Cancer drugs, anti-inflammatories, antibiotics, neurological treatments - the shortage of medicines affect all therapies, and is likely to jeopardise patient prognosis.

Therefore the pharmaceutical strategy for Europe unveiled by the European Commission is clearly insufficient on this point. Despite the accuracy of the shared diagnosis, the concrete proposals by the Commission - which wants to go through a consultation process to identify potential measures and political options –completely misses the urgency of the situation. They have ignored the Parliament’s proposals - and those of the Greens in particular - to set up European non-profit pharmaceutical establishments, able to relocate missing active ingredients to Europe and ensure the production and supply of those essential drugs neglected by industry.

Yet no legislative date has been announced by the Commission. This is a pharmaceutical strategy dealing with the needs of manufacturers, rather than patients. Overall, the Commission’s pharmaceutical strategy leaves me perplexed. Beyond its advances, in particular its commitment to reducing pharmaceutical residues in the environment, it remains tailor-made for industry, digital, new GMOs or GMO-based drugs.

It facilitates the marketing of therapeutic innovations without calling into question the patents and the exclusive rights of manufacturers. They will be able to abuse - again and again - their dominant market position and maximise their profits to the detriment of taxpayer’s money or the best interests of patients.

Knowing the real breakdown of the price of a drug, for example - such as its share of R&D that results from public research - contributes to gauging the accuracy of its price or the fairness of the advantages conferred on its manufacturers. The promise of new treatments for all should not reinforce their monopolies.

“We know the remedies; the European Parliament has stated several of them. Why is the Commission waiting to respond to the most urgent needs?”

Many abandoned or neglected remedies are perfectly effective in meeting existing therapeutic needs. Remedies already known, or which have entered the public domain, should also be taken into account. The causes of the shortage of medicines are varied. But all are the consequence of choices aimed at optimising costs and profits. We know the remedies; the European Parliament has already stated several of them.

Why is the Commission waiting to respond to the most urgent needs? The control of pharmaceutical production by manufacturers alone, and the laxity of the authorities in grasping the scale of the challenge, are the sources of price-gouging and are endangering the lives of patients. These practices are no longer acceptable.

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