EuropaBio Position paper on the pharmaceutical package

07.04.2009
Safe, innovative and accessible medicines: A renewed vision for the pharmaceutical sector position paper on the Pharmaceutical Package

Overall EuropaBio welcomes and supports the Pharmaceutical Package and is looking forward to working with all EU Institutions on the adoption and implementation of this package. 

1. European Commission’s Communication on Safe, Innovative and Accessible Medicines: A Renewed Vision for the Pharmaceutical Sector
 
We are pleased to see the emphasis the Commission places in the Communication on restoring a strong, innovative and competitive EU pharmaceutical sector and on avoiding delays for patient access to innovative treatments. Timely access and appropriate reward to biological therapies are key components to meet those objectives, especially in times of financial and economic crisis. 
 
However in Europe, there continues to be no consensus on how to reward and stimulate healthcare innovation and ensuring access to new treatments for patients. This coupled with inconsistent pricing and reimbursement policies and increasing safety requirements contribute to the decrease of approved new therapies within Europe and to the impediment of timely availability of innovative medicines for patients.
 
Therefore Europabio calls for the implementation of better practice principles for relative effectiveness assessments as well as pricing and reimbursement policies as defined in the Pharma Forum conclusions and recommendations; and for the EC to develop a mechanism to ensure that this new vision is implemented in a harmonised manner.
 
2. Ensuring that EU citizens have access to reliable information 
 
Sufficient and equal access to quality health information for patients and their families on diseases, their prevention as well as available treatment and care options is of utmost importance. This is particularly relevant for biological products as those products are far more complex than small molecule products. We are also pleased that the proposal identifies industry as a legitimate source of information.
 
Rightfully, the EC’s proposal does not open the way for advertising on medicines; and we call Member States, the Commission and other stakeholders to take note  of existing partnerships and collaborations between the various parties that mobilise knowledge and resources for producing and disseminating information to patients. 
 
3. Strengthening the EU system for the safety monitoring of medicines (pharmacovigilance) 
 
EuropaBio welcomes the EC proposals to strengthen and rationalise pharmacovigilance in the EU as well as the recognition by the Commission that when it comes to identification of medicines, biotech medicines face particular challenges due the nature of such products.  We support a risk-based approach to the pharmacovigilance system. Accordingly the reporting requirements and risk management plans should reflect this approach, taking account of the product types and the underlying mode of action of the medicinal product. The additional labelling requirements as well as information presented on a new public safety web-portal will enhance transparency on safety features of our products for the patients and the public, which is in line with the needs for more and better information for EU citizens. 
 
4. Strengthening EU legislation to better protect EU citizens from the serious threats posed by fake medicines
 
The ultimate goal of this EU legislation and overriding consideration must be to ensure patient safety – now, and 
for the future. 
 
We are particularly concerned about the threat caused by fake medicines, because the distribution chain for 
biotech products is far more complex than for small-molecule drugs. Counterfeit biologics may be extremely 
difficult to detect in the supply chain before they reach patients and do harm.  
 
Therefore EuropaBio calls for a ban on the manipulation of the safety features and/or packaging of the original 
manufacturer. Responsibilities and liability principles should be strengthened to provide adequate incentives for 
all stakeholders involved to check for counterfeit  products. Should re-packaging occur, product liability for 
counterfeits or falsified products resides with the re-packager. 
 
5. Timeline 
We call the institutions should ensure that the vision of a strong, innovative and competitive EU pharmaceutical 
sector which provides timely and equitable access to innovative medicines to patients is swifty approved.