The review of the EU's pharmaceutical strategy is (still) postponed

The review of the EU's pharmaceutical strategy is (still) postponed

The reform package expected on March 29, after an initial postponement from the 14th, is not yet ready

eunews – 28 marzo 2023

Brussels – Skip, once again, the EU pharmaceutical strategy review package. first in calendar by the end of 2022, then scheduled for March 14 and again for tomorrow (March 29). Nothing to do, the European Commission has decided to postpone its presentation to a later date. In November 2020, in the midst of the second wave of the Covid-19 pandemic, the European Commission launched a pharmaceutical strategy for Europeto, one of the pillars for the construction of aEuropean Union stronger and with more expertise in healthcare. It is within the framework of the pharmaceutical strategy presented two years ago that the European Commission amends the current pharmaceutical legislation in the EU to adapt it to future needs. The pharmaceutical package includes the review of pharmaceutical legislation, the review of EU legislation on medicines for pediatric use and rare diseases, and a Council recommendation on stepping up EU actions to fight antimicrobial resistance.

From access to medicines at low prices, innovation and sustainability of the pharmaceutical industry, passing through a crisis-proof regulatory framework. A review of pharmaceutical legislation and six key objectives to contribute to the construction of a European Union with more competences in health. The EU Commissioner for Health anticipated the challenges that this revision will try to address, Stella Kyriakides, confirming in recent weeks that one of the priorities of the strategy will be to reduce the environmental impact of the pharma industry. According to Brussels, environmental risk assessments they will be an integral part of the authorization dossiers for new drugs. Already in the pharmaceutical strategy presented in November 2020, part of the action plan is dedicated precisely to the ambition of making the pharmaceutical industry contribute to the "zero pollution" objective for an environment free of toxic substances, in particular through the impact of pharmaceutical substances on the environment.

The pharmaceutical strategy paves the way for industry to contribute to EU climate neutrality, with a particular focus on reducing greenhouse gas emissions along the value chain. Among the other pillars of the review, Brussels wants to ensure that all Europeans have access to innovative medicines when they need them. While now - notes the Commission - the reality is that of a fragmented internal market where medicines do not reach patients quickly enough and not in all Member States at the same time. Then, the communication will provide incentives for innovation, to improve the competitiveness of the sector. And again, reform will seek to face the challenge of shortage of medicines, which has gripped Europe in recent months on the one hand due to the sharp increase in demand for medicines due to more respiratory infections, on the other hand insufficient production capacity. There will be stricter procurement obligations and inventory transparency. Shortages and withdrawals must be communicated in advance and theEuropean Medicines Agency (EMA) will have a stronger role in coordinating actions against deficiencies.

The last point will be like fight antimicrobial resistance, which according to Brussels currently causes more than 35,000 victims a year. The review should include measures both for stimulating new antimicrobial products and for more prudent use. Then another space in the reform will be guaranteed for simplification, regulatory modernization and digitization. A leaner regulatory environment for investment with simplified and faster marketing authorization procedures, stronger support for promising medicines and better use of data and digitisation.

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DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001