What can the EU do to improve access to medicines?

Questions without easy answers are often ones that provoke change.

This is certainly true of questions about access to medicines, which have been at the heart of the EU health debate for the past year or more.

Are all the key players acting in a way that allows patients to get access to essential and innovative medicines when they need them? In a policy context, is there anything that the EU can – or even, should – do to help improve patient access to medicines in Europe?

To begin to answer these questions, there is a need to understand that the pharmaceutical industry is something of an anomaly.

Companies exist as private legal entities driven by a profit motive, with their discoveries covered by patents and data exclusivity rights. However, medicines are not normal products. They are not subject to the fluctuations of the market and its normal rules.

In light of health crises that have focused attention on disparities in ability to pay, the industry and their principal customers (national governments), have come to certain understandings about access to medicines across Europe. Companies need to make a profit, but those same companies are obliged to respect the limitations of their customers’ budgets, allow prices to reflect lower purchasing power in poorer countries, and make their products available (especially as they are frequently essential for saving or improving lives) as a social responsibility.

During a debate in Strasbourg this week, the Commission Vice President for Jobs, Growth, Investment and Competitiveness, Jyrki Katainen (pictured), confirmed the Commission’s commitment to help member states address the challenge of access to medicines. However, words do not always lead to action.

The Commission’s ability to act is limited, as national governments control the financing and provision of healthcare. The principal tool in Katainen’s locker is the Commission’s power to ensure the full and proper functioning of Europe’s single internal market.

A review of the Transparency Directive – which was established to speed up access to medicines by setting clearer time limits for the negotiation of medicine pricing agreements and removing protectionist national preferences for domestic pharmaceutical companies in the early days of the single market – is currently on hold.

The Cross-Border Healthcare Directive, the other EU-level tool designed to improve access to medicines, is still yet to be fully tested. Its implementation requires a financial and political commitment from national governments, who have so far dragged their feet.

The Commissioner for Health and Food Safety, Vytenis Andriukaitis (pictured), has stated his intention to address this issue during his term in office. How much this will achieve for patients is open to question, but it is currently the only game in town, with a lean legislative programme for 2015 featuring no specific healthcare-related measures.

However, at an administrative level, things are stirring. Two weeks ago, a Commission expert group on safe and timely access to medicine for patients (known as STAMP) met for the first time. The STAMP group will look at ways to encourage innovation and make access to medicines easier with the scope of existing laws and regulations.

The mechanics of bringing a medicine to the market are an important factor in determining access, and there are doubts over whether some classes of medicine that are expected to be developed over the coming years will be widely accessible. For years there have been long market access delays in many countries – with patients in one EU country lagging far behind those in other EU countries in getting access to new and better medicines.

The Council, too, is discussing access to medicines – and in particular setting objective criteria for the assessment of the value of medicines. EUnetHTA, a body that is leading discussions on the implementation of ‘health technology assessments‘ (HTA), is looking at how we determine the value of a medicine and our ability to draw such conclusions based on clinical research.

Their conclusions will inevitably have an effect on how companies innovate and deliver new medicines to the market, and how much governments are willing to pay.

Other forces are also moving. The European Patients Forum is working with Andrey Kovatchev MEP on a Parliamentary interest group on access to healthcare and a Patient Access Partnership, which gathers together groups interested in and committed to the issue.

This initiative is at an early stage, and could move in a number of directions, though it appears to have momentum and organisational strength behind it.

One of the earliest parliamentary debates of the 2014-19 mandate asked whether pharmaceutical companies are unfairly hard-nosed in their negotiations with governments over medicines prices. This debate saw MEPs calling for solutions such as compulsory licenses (effectively voiding established intellectual property rights) and EU-level procurement of medicines.

This week’s statement by Katainen may have shed light on what the Commission plans to do to improve access to medicines. It touched upon many of the concerns raised above, and even hinted that joint procurement might be a viable option for the future (starting with vaccines). It is easy to assume that the ‘sharing of best practice’ mantra might be wheeled out again as the Commission’s response to a pressing public health issue, though increasing pressure from the Parliament and some member states makes new assertive policies more likely than not.

One simple step that might be envisaged would be for national pricing and reimbursement negotiations, once commenced in one country, to be regarded as underway in all others. Such a simple procedural step – mutually recognising the start of a new medicine’s launch – would radically transform the patchwork of delay and inaction in member state provision of new medicines to their patients, bringing a new and much-needed unity to the fight to alleviate pain and disease in Europe.

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Words  Sam Kynman and Elena Bertozzi
Photos  (c) European Union 2015

 

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