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What does the reform of the pharmaceutical sector proposed by the EU Commission foresee?

What does the reform of the pharmaceutical sector proposed by the EU Commission foresee?

The proposal for reform of the pharmaceutical sector put forward by the European Commission divides the Member States and causes a stomach ache for Big Pharma, which is already fighting through the lobbies. All the details

Brussels is not just talking about the reform of the Stability Pact but also about the reform of the pharmaceutical sector which, after 20 years, aims to make access to medicines safer and more convenient, encourage innovation and reduce bureaucracy.

This is what the European Commission's proposal provides.


Postponed for years, the pharmaceutical sector reform, a draft of which was circulated in January, was officially presented yesterday. In fact, the European regulation on medicines had not been touched on for two decades and concerns many issues: from access to the shortage of medicines, up to the regulatory authority of the sector.


"Currently – observes Politico – patients in the poorest eastern countries of the EU receive new drugs years after their western counterparts", this is because the richest countries can pay to receive innovative medicines without having to wait for cheaper alternatives.

The Commission has therefore proposed to abolish inequalities, reducing by two years (from 10 to 8) the time that new branded medicines have to be placed on the market before being launched by competitors, and allowing pharmaceutical companies to recover these two years only if the launch takes place in all 27 EU markets.

"Drugs that treat an 'unmet medical need' – explains Politico – will get six months longer, as will drugs for which the developer conducts a clinical study with a competitor drug (which makes price negotiations easier) ”, while “drugs that treat other diseases in addition to the main one will get an extra year of protection”.


This perhaps – together with the previous measure – is one of the issues that Big Pharma will have the most difficulty digesting and for which they will fight the most. In fact, the Commission wants to make it much easier to implement a compulsory license in case of emergency, i.e. a tool that allows governments to bypass patents to guarantee supplies.

Added to this would be the suspension of the protection of regulatory data, i.e. the data necessary – even in the presence of a compulsory license – for manufacturers of generic drugs to place alternative options on the market.


Again according to the proposal, major changes would also concern the European Medicines Agency (EMA), which should provide greater scientific advice to drug manufacturers and faster data evaluations. Simplified procedures which, for Politico , are sold by the Commission as an advantage for Big Pharma, even if "whether the sector agrees remains to be seen".


The shortage of medicines in Europe, which has been particularly felt this winter , would like to be solved by building up emergency stocks of medicines or ingredients to produce them.

"Other measures – says Politico – include the obligation for companies to notify the authorities six months in advance of any supply problems and to prepare plans to prevent shortages".

By the end of this year, EMA will draw up a list of critical medicines to monitor their availability and help coordinate a response. Furthermore, through the creation of a site, information relating to deficiencies will be made public.


Another problem mentioned several times lately is antimicrobial resistance, responsible for 35,000 deaths every year in Europe, of which 11,000 in Italy alone , which in fact, in the EU, is second only to Greece.

The Commission has therefore proposed a "controversial" incentive, as Politico calls it, in which it would reward developers of new antibiotics with a salable voucher that guarantees one year of data protection for a drug of the company's choice.


Finally, the proposal also aims to reduce the environmental impact of the pharmaceutical industry. To intervene concretely, the Commission would like to give the EMA the possibility of refusing to approve a drug in the event that the developer does not provide sufficient information on the potential environmental risks for which it is responsible.


The reform proposal will now have to be examined by the Council and the European Parliament, close to the 2024 elections.

But despite the health commissioner Stella Kyriakides, using the words of the singer Bono Vox, recalled that "the place where you live should not determine whether you live or die", according to Politico there are discontents – especially on the grip on intellectual property – by the pharmaceutical sector, which "has already exercised an intense lobbying activity against the main provisions".

“Several big names in the industry – continues the newspaper -, including the executives of Novo Nordisk and Novartis, have declared that pharmaceutical companies will probably go abroad. And Big Pharma has made it clear that it has friends on the upper floors”.


Meanwhile, according to Politico , the sides seem to have already formed with Germany, Italy and Denmark against the proposal, and Austria, Estonia, Hungary, the Netherlands, Poland and Slovakia in favor.

As Il Sole24Ore points out, the pharmaceutical sector is one of the sectors of excellence in our country and the reform, conceived in this way, risks "making the Old Continent and our country lose a slice of the 1,600 billion dollars of investments planned between now and 2028 to discover new therapies in favor of the USA and China that we are already forced to chase today".

Above all, the reduction of market exclusivity reserved for new drugs from the current 10 years to 8 may no longer attract the important investments of Big Pharma. Already today, observes the business daily, "if in 2001 the USA and Europe were almost evenly matched (44% against 41%) twenty years later the USA attracts 52% of investments, against 31% for the EU and with the East growing (17% between China and Japan)”.

Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations (Efpia) also spoke to Politico of the same risk last January when a draft of the proposal was circulated: a more conscious decision by Europe to rely on the innovation of the United States and Asia, everyone should be assured that what we have seen as a draft legislative proposal would be extremely damaging to the competitiveness of the European innovative pharmaceutical industry”.

European Affairs Minister Raffaele Fitto had expressed his opposition to those advances and the Italian government is preparing to do battle: "While sharing the general aim of guaranteeing timely and fair access to safe medicines on the European market – Fitto told Sole24Ore -, the proposals put at serious risk the protection and competitiveness of the pharmaceutical sector which represents a strong point of our economies. Our position is clear, we are already working ahead of the negotiations both in the Council and in Parliament”.

This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/cosa-prevede-la-riforma-del-settore-farmaceutico-proposta-dalla-commissione-ue/ on Mon, 01 May 2023 15:02:51 +0000.