Reform of the pharmaceutical sector by the EU Commission

by: Paola Cinquanta, Operations Manager – Regulatory Affairs & Senior Associate Partner @PQE Group

The European Commission and the EMA have published a roadmap for a European medicines agencies network strategy to address challenges posed by the COVID outbreak. The reform aims to ensure rapid access to high-quality medicines for all EU patients and equal access across member states. Delays in market availability of new medicines and unequal access are deemed unacceptable. The reform also targets specific health needs like rare diseases and antimicrobial resistance, considering the latter a significant future challenge. Tackling pricing issues of innovative medicines and positioning Europe as a global leader in medicine development are additional objectives. Digital transformation and assessing the environmental impact of medicines are key areas for improvement. These efforts align with European political objectives such as the green deal and the green economy. 

Reform EU Commission_Site_PQE

As all of our attendees probably know, in recent years, Governments and Health Authorities from all over the world have faced numerous challenges linked to the COVID outbreak, and this includes the European Commission. These challenges have resulted in medicine shortages and the need to provide access to high quality medicines to all European citizens in a timely manner. In 2020, in response to the crisis, the European Commission and the EMA published a roadmap to 2025 for a European medicines agencies network strategy, leading to a complete reform of pharmaceutical law. 

One of the main objectives of this reform is to ensure the rapid availability of high-quality medicines to all EU patients. Currently, there is a problem in Europe in which new medicines cannot always reach the market quickly enough to be immediately accessible to all patients across Europe. Unfortunately, some patients do not have enough time to wait for new therapies to become available. Additionally, there is a lack of equal access to medicines across all member states. Some states grant immediate access to new medicines, while others impose delays of up to one year. The European Commission finds this unacceptable and aims to provide the same level of health standards to all European citizens

Furthermore, there are specific health needs to be targeted, such as those related to rare diseases and the serious problem of antimicrobial resistance. The European Commission is particularly concerned about antimicrobial resistance, which is considered a silent pandemic which could pose significant future challenges. Addressing this issue is a major objective of the reform. 

There are also challenges related to the prices of innovative medicines, particularly those that are developed using innovative techniques. Prices of such medicines tend to be high, making it difficult for the public health system to ensure therapy for all patients. Thus, another important objective of the reform is to tackle pricing issues. 

In parallel to these main objectives, there is a general effort to position Europe as a global leader in medicine development and maintain its attractiveness for pharmaceutical investments. Two key objectives applicable to all sectors, including the pharmaceutical industry, are digital transformation and the environmental impact of medicines. The European authorities have taken steps in the past, but now they seek to reach a new level of assessing the environmental impact of medicines. These efforts are in line with the overall goals of the European political objectives, such as the green deal and the green economy. 

 
 

Are you ready for change?

PQE Group can support your business in reaching the compliance for your products as well as in implementing new procedures, tools and software.

To get more information or support, get in touch with us  or check our Quality Compliance dedicate page to find the most suitable solution for your company.


Connect with us