CommonSense Blog

EU and Market Access – is change on the horizon or will it fall foul to EU bureaucracy?

By Sarah Horgan | Aug 05, 2013

EU legislation is no barrel of laughs. Having spent many hours deciphering tobacco and food labelling directives in my previous role as the advocacy officer at the Irish Heart Foundation; I think I’m allowed say that with confidence. However, these hours spent getting friendly with EU legislation have shown me that EU directives are one of the most powerful tools in the Union’s disposal. Directives are developed by the European Commission with input from other institutions and third parties, then, they are voted on and passed by the European Parliament. Member States have to adapt their laws to meet the goals of the directives, but Member States are free to decide how to go about making these changes within a specified timeline. So with 28 Member States (welcome Croatia!); delay and disagreement are inevitable throughout the process.

Previous EU pricing and reimbursement procedures for medicines mainly involved the submission of an application, followed by a decision-making process to determine the price of the medicine and/or its eligibility to reimbursement. However, with the evolution of innovative medicines, the increases in healthcare costs and the establishment of health technology assessments (HTAs), the process has become more cumbersome and in need of an overhaul. In fact, studies show that delays in pricing and reimbursement decisions could be up to 700 days for innovative medicines and up to 250 days for generics. Based on this research the EU Commission developed a proposal to update pricing and reimbursement procedures.

EU Parliament Plenary Vote on the Proposal

The proposal encourages faster pricing and reimbursement decisions and stronger enforcement measures – win, win for both patients and industry as access to medicines is improved. But least you forget, this is Europe, and Member States are facing austerity and massive reductions to health budgets. Unsurprisingly, negotiations in the EU Council have proved to be difficult when Member States raised a number of concerns around amendments to shorten the time Member State governments are allotted to complete and publish pricing and reimbursement decisions.

What are the proposed changes?

Below is an overview of the key points of the proposal which are currently undergoing additional amendments prior to another EU Parliament vote.

Proposal Amendments

Benefit to Our Clients

My Perspective

Guaranteeing shorter time limits for national, regional or local decisions on pricing and reimbursement
  • Medicinal products reviewed in 120 days instead of 180 days, except for complex procedures
  • Generic medicinal products reviewed in 30 days instead of 180 days when the price of the reference product has already been approved or has already been included in the public health insurance system
There was little support for shorter maximum time limits for completing and publishing pricing and reimbursement decisions for innovative medicines so this amendment will likely be “watered down” in the final adopted version
Increasing the effectiveness of the Directive by proposing strong enforcement measures, i.e. in case of non-compliance with the time limits, a Member State has to designate a body entrusted with the powers to take rapid measures
  • A penalty payment, calculated by day of delay, will be imposed on governmental bodies responsible for decisions if the time limit is exceeded
There was disagreement about the enforcement role of the EU. As such, expect a reduction of the key tools that would enable a better enforcement, including the remedies for infringement of EU law at a national level, requirements for dialogue with stakeholders and regular monitoring of implementation

 

Overall, there is strong support for this directive in the parliament so adoption at the next EU Parliamentary vote is likely. As it stands the changes will improve the pricing and reimbursement process in the following ways:

  • More comprehensive and tailored files for product approval/pricing/reimbursement submissions
  • More favourable public health/treatment/regulatory guidelines
  • Reduction of lead time in approval
  • Preferable labelling and indication
  • Better price and reimbursement conditions as an updated structure is implemented

However, a timeline for consultation has not been published by the European Parliament – so I’ll be sure to watch this space and keep you all informed of any developments in Brussels.