The European Commission is planning to re-open basically all files related to the pharmaceutical industry with its roadmap for a new Pharmaceutical Strategy, seen by EURACTIV.com.
The roadmap is expected to be published in the coming days and is paving the way for the planned pharmaceutical strategy due in the last quarter of 2020.
The document says it aims to review Orphan and Pediatric Regulation, legislation on fees for the European Medicines Agency (EMA), as well as the basic pharmaceutical legislation which dates back to 2001.
It also envisages non-legislative action such as a plan on shortages.
“The overall goal of the initiative is to help ensure Europe’s supply of safe and affordable medicines to meet patients’ needs and support the European pharmaceutical industry’s innovation efforts in the EU and globally,” the document reads.
However, the EU executive will have its work cut out in solving this equation.
A major issue that has raises the eyebrows of the pharma industry is the Commission’s intention to examine the affordability of medicines for patients and national health systems, especially for smaller markets.
“Innovative and promising therapies do not always reach the patient due to market failures, lack of competition, high prices, lack of transparency, companies’ marketing strategies and pricing mechanisms,” the roadmap says.
For this reason, the executive wants to review incentives and obligations for market entry. “Promote regulatory and administrative simplification and increase the overall transparency in the sector to support need-driven patients,” the document adds.
The executive also aims to enhance EU cooperation on assessing the cost-effectiveness of drugs value, as well as pricing and reimbursement through information sharing.
The Commission also intends to ensure that the industry invests in areas where there is an unmet medical need, and wants to make pharma more environment-friendly by reducing pollution throughout the whole life circle of pharmaceuticals.
Another issue the Commission wants to address is how to reduce Europe’s growing dependence on imports of medicines and active pharmaceutical ingredients.
“This objective calls for supporting EU regulatory presence and global influence aiming to achieve a level playing field for EU companies through harmonised international standards of quality and safety of medicines […] Encourage and support a strong EU manufacturing capacity for active pharmaceutical ingredients,” the document says.
[Editing by Zoran Radosavljevic]