“Taken at face value, it might seem that there is little reason for patient and patient organisations to get involved in the elections for the European Parliament that will take place next May. After all, the provision of health care is the responsibility of the member countries of the EU, and European Institutions have only a very limited authority to intervene in areas related to public health, so getting involved requires a lot of effort for very little potential benefit.
Is this “Eurosceptic” view justified? Or is it a manifestation of an Ostrich mentality – sticking your head in the sand in the belief that if I cannot see you, then you cannot see me, so all will be well. Clearly each patient and each patient organisation must make their own decisions about getting involved. This will be influenced by individual priorities and the resources available.
Here are some of the issues currently under consideration by the European Commission and the European Parliament that might help you make up your mind!
Before a new medicine can be prescribed for patients it must secure a Marketing Authorisation. This says the product is sufficiently safe and effective to be provided to patients. Increasingly this is decided by the European Medicines Agency (EMA) – for some types of drug EMA rather than member state approval is mandatory. Many of the EMA’s scientific committees have patient representatives, including representatives of EPF and EGAN, working hard to ensure that the experience of patients and families is factored in to licensing decisions.
After Marketing Authorisation comes Health Technology Assessment. This is the framework for deciding about cost and clinical effectiveness and hence whether or not patients can be prescribed new therapies. Increasingly there are measures being put in place to harmonise the decision making framework for HTA, and the EU Network for HTA is developing common practices and guidelines for member states to adopt. Historically HTA has been seen as a rational process for decision making – like making a cake. Put in the ingredients, stir and bake and you get the same result every time. Unfortunately, the recipe used left out some of the essential ingredients. These are the issues that matter to patients, rather than those that matter to policy makers, so the resulting cake was less tasty than it should have been! European harmonisation is an opportunity to make sure that the HTA cake can be improved across the EU by including those things that are important to patients into the recipe.
Of course, many diseases have no effective therapies. The EU’s research budget has created opportunities for pan-European collaboration in cutting edge research and development. This has been important in a wide range of diseases areas including neurological conditions, cancer and rare diseases to name but three.
Progress for patients with rare diseases has been particularly significant due to EU interventions. DG SANCO, the part of the Commission that deals with health issues, has played a key role in the development of National Plans for improving services for rare disease patients through the work of the Rare Disease Task Force, and its successor body, the EU Committee of Experts on Rare Diseases.
It’s not just about measures and Institutions that already exist. Pan-European legislation also influences directly patients’ prospect for improvement. High quality care depends on sustained research and the application of the outcomes of this research in better services and support. Effective communication and appropriate sharing of information are essential to high quality care. Proposals currently before the European Parliament to tighten up Data Protection Regulations may threaten our abilities to share medical and research data in ways that patients and families would wish and see as appropriate. Revisions to the rules for clinical trials, also under consideration now, provide an opportunity to shape the way in which new products are developed and improve patient access. Left to the “experts” there is no guarantee that patient and family views will be taken into consideration, and a framework that is fit for purpose.
All patients hope for the provision of safe and effective treatments for their condition. Despite massive progress in recent years there remain many diseases for which little or nothing can be done. Initiatives such as the international Rare Disease Research Consortium, a €/$400m programme that will run until 2020 has set the ambitious goal of developing a diagnostic test for all rare conditions, and to bring 200 new therapies to the market.
I believe that the concerted efforts of organisations such as the European Patients Forum to influence regulation and set policies that are patient friendly at the Commission and at the European Parliament have been vital in getting us to where we are today. Patient advocacy at the EU level has been an effective tool in bringing about positive change for those with unmet medical needs in Europe.
The elections next year provide an opportunity for candidates to hear and listen to the patient voice and in so doing to help set the priorities for the new parliamentary session. Whether or not they get the chance to listen depends on patients and patient organisations make the effort to share their issues and concerns with them. It will be up to all of us to decide whether we want to get involved or are we content to leave it to “someone else” to do it.
In my view we should all support the efforts of the EPF and make sure that the next European Parliament is alive to the patient and family perspective on issues that affect us all.”