Pharmaceutical package
Safe, innovative and accessible medicines : a renewed vision for the pharmaceutical sector.
December 10th, 2008, the European Commission adopted a Communication and three legislative proposals with the overarching objective of ensuring that European citizens can increasingly benefit from a competitive industry that generates safe, innovative and accessible medicines.
For the full press release including a statement from Vice President Günter Verheugen click here : en, fr, de
Since the beginning Community action in the pharmaceutical sector has had the dual objective of safeguarding public health, by providing Europe with safe and effective medicines, while creating a business environment that stimulates research, boosts innovation and supports the competitiveness of industry. Much has been achieved in the past forty years. However, today Europe is faced with major health, economic and scientific challenges. The EU has been losing ground in pharmaceutical innovation, European patients still suffer from inequalities in availability and affordability of medicines, and counterfeit medicines are on the rise.
The Communication on the future of the pharmaceutical sector adopted today by the European Commission outlines these challenges, sets out a vision for the future of the sector and proposes deliverables for the years to come.
- Summary of the Communication :
Together with the Communication, today the Commission also adopted a series of legislative proposals that will contribute to strengthening current legislation by addressing existing gaps:
The first legislative proposal aims at ensuring that EU citizens have access to reliable information on medicines available, the grounds on which they have been authorised and how they are monitored. Today EU legislation does not provide for sufficient harmonised rules in this area and as a consequence EU citizens have unequal access to information across the EU. The overall principle of the proposal is to lay down clear rules on information provided by pharmaceutical companies on prescription-only medicines. This proposal is very important for patients as it will help empower EU citizens to make more informed decisions about their health.
If you want to have more information on the legal proposal see below:
For background information on information to patients click here
The second legislative proposal aims at better protecting patients by strengthening the EU system for the safety monitoring of medicines (pharmacovigilance). Once approved and placed on the market medicines are monitored throughout their lifespan to ensure that any product, which presents an unacceptable level of risk, can be rapidly withdrawn from the market. In fact the full safety profile of medicines can only be known once they have entered the market. The supervision and monitoring of adverse reactions of authorised medicines are done through the EU’s pharmacovigilance system. The current system is however complex, leads to duplication of effort as well as potential for confusion of responsibilities. A lack of harmonisation not only interferes with the functioning of the single market in pharmaceuticals but also poses a threat to public health. The Commission’s proposal aims at simplifying the current system with the overall objectives of better protecting public health, ensuring the proper functioning of the internal market and simplifying the current rules and procedures.
If you want to have more information on the legal proposal see below:
For background information on pharmacovigilance click here
The third legislative proposal aims at strengthening EU legislation to better protect EU citizens from the serious threats posed by fake medicines. There is an alarming increase of medicinal products detected in the EU which are false representations of authorised medicines. These products usually contain sub-standard or false ingredients, no ingredients or ingredients in the wrong dosage thus posing a serious threat to human health. The overall principle of the proposal adopted today by the European Commission is to protect the legal distribution chain from the infiltration of fake medicines. This will help to ensure confidence of distributors, health care professionals and patients in the medicinal products they trade, prescribe and purchase in the legal supply chain.
If you want to have more information on the legal proposal see below:
- Summary of the proposals :
- Brief background information : en
- Text of the proposal : click here
- Executive summary of the Impact assessment : click here
- Impact assessment : en
For background information on fake medicines click here
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