Price transparency and timing at risk, warns EFPIA
pharmafile | June 9, 2011 | News story | Sales and Marketing | Drug pricing, EFPIA, medicines pricing, pricing
Europe’s pharmaceutical industry has warned that a review of EU law could undermine the pricing and reimbursement of medicines.
The Transparency Directive has been in place for 22 years, and has been one of the few EU laws to enforce transparent, predictable and timely pricing and reimbursement decisions across the continent.
Now the European Commission is looking to update the Directive, and pharma organisation EFPIA fears it could be watered down, allowing EU countries to introduce price cuts and controls without accountability or transparency.
EU member states have full autonomy over how they run their healthcare systems and medicines purchasing, but the Transparency Directive demands transparent decisions, and enforces a deadline for pricing and reimbursement.
The European Commission says it has launched its review because pricing and reimbursement measures are “much more varied and complex than they were twenty years ago” – but EFPIA fears member states could seize the chance to weaken the law.
EFPIA’s Director General Richard Bergström said it was ‘unavoidable’ that problems with the economy and public spending across the EU would influence the review.
Bergström stressed that cost control in general and pharma price levels “must not dominate the review.”
He added: “We must remain focused on what the Directive has aimed to achieve over the years and ensure that the spirit, its contribution towards improving the mechanisms with which member states control pharmaceutical prices and reimbursement and how efficiently and speedily they grant access to patients, remains intact.
‘‘If not, we risk taking two steps back instead of a step forward towards better functioning pharmaceutical markets and access to innovation.”
The Commission also wants to take into account the case law developed by the European Court of Justice, and the outcomes of the Pharmaceutical Sector Enquiry and of the pharma market monitoring, as well as developments in the market and in national pricing and reimbursement regulations.
The Commission says it will also consider reviewing the pricing and reimbursement systems for medical devices.
Push to lower EU patent costs
The Commission also recently announced plans to reduce the cost of filing a pan-European patents by up to 80%.
Draft regulations put together by the Commission will now pass to the Council and the European Parliament for consideration.
Obtaining a pan-EU patent is currently expensive and complex. The European Patent Office (EPO) handles all applications, but the inventor must gain validation in each country where patent protection is sought, raising the cost dramatically. Total average costs are currently €32,000 ($45,000) for patent protection in all 27 Member States. The Commission wants to see costs for a European patent to eventually fall to €680 ($966). Gaining a US patent costs around €1,850 ($2,627) on average.
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