BlogEntering the EU MarketEU Product Registration Ep.6

EU Product Registration Ep.6

At the end of April 2023, the EU Commission announced the largest reform of the pharmaceutical sector in over 20 years. Why is this happening right now, and what should we expect from pharmaceutical legislation? 

As all of our attendees probably know, in recent years, both the world and the European Commission have faced numerous challenges linked to the COVID outbreak. These challenges have resulted in medicine shortages and the need to provide high-quality, accessible medicines to all European citizens. In response, the European Commission, which realized this was necessary in 2020, published a roadmap for a new health system, leading to a complete reform of pharmaceutical law. 

The main objective of this reform is to ensure the rapid availability of medicines. Currently, there is a problem in Europe where new medicines cannot always reach the market quickly enough to be immediately accessible to patients in need of therapy. Unfortunately, some patients do not have enough time to wait for these medicines 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 needs, such as those related to rare diseases and the growing problem of antimicrobial resistance. The European Commission is particularly concerned about antimicrobial resistance, which they view as a silent pandemic with 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 developed using innovative platforms. These prices 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 aim 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 align with the overall goals of the European legislation, such as the green deal and the green economy. 

On top of these developments in this new law, it is important to mention an important change regarding GMP, which entails the adapted requirements for the qualification of the qualified person. Previously, these requirements were regulated by Article 48 of Directive 2000 and 183, but they will now be defined as an annex to Directive 223-132, specifically listed in Annex three. Additionally, there is also relief concerning the written confirmation. Member states may now waive the requirement of the written confirmation within the scope of the validity period of the GMP certificate. This change will be listed in Article 158 of Directive 223-132. Lastly, another aspect related to this is the electronic product information, where paper leaflets will now be substituted with electronic versions. 

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