On the 4th March, the ECL Patient Support Working Group held a capacity building day for members on two pieces for current EU legislation relevant for patient support: the Clinical Trials Directive which is currently under revision and the Patients’ Rights to Cross-border Healthcare directive which will be implemented later this year.

Proposed Clinical Trial Directive in the Context of Patient Support Services, Ward Rommel (VLK) and Anastassia Negrouk (EORTC)

Clinical trials are important for the improvement of treatment, quality of life and survivorship of cancer patients which makes it very important to have good legislation to regulate them. The current clinical trials directive has been criticised for having too much red tape and making trials too difficult to organise. IT encouraged trial sponsors to take out very expensive insurance and tried to harmonise clinical trials legislation in diff countries which in the end resulted in much less harmonisation making international trials very complicated. In addition, the directive as it now stands says nothing about patient involvement which does nothing to create patient confidence in trials.

Now the commission is strengthening the current directive to a piece of legislation that will in part over ride national regulations about clinical trials in the areas that are the competence of the EU. These include the creation of a single portal for all sponsors to submit to national ethics committees and cooperative assessment mechanisms which aim to cut down on bureaucracy. The second part of the legislation covers areas that are not in EU competency but will remain in national control. This includes information to patients which can have a harmonised content but will clearly need to be delivered in the national language.

The new proposed regulation is much more patient centred, making him/her an active player in the story. This has been the result of strong political voices coming from the patients, who have actively established themselves in advocacy groups to influence the legislation.  As a result, patients and patient representatives are becoming partners in the research. Some members of scientific community may resist this but they no longer have a choice the legislation is requiring that each member state has patients on the ethics and review panels. In addition, the Rapporteur of the new legislation has also introduced an amendment which says that the pertinence of the trial must be seen to be what the patient needs. This may well mean that patients will be asking for trials to consider quality of life aspects to drugs that scientists may not think about immediately.

The experience of the EORTC in working with patient groups has been shaped by the sheer number of different kinds of groups in existence and their different levels of professionalism, capacity to understand the mechanisms of clinical trials and a lack of access to information about trials. They have attempted to reach out to groups in different ways by providing one day training courses for example and producing information. In France and the UK they are working with the cancer league and voluntary organisations to review the documentation about trials to make the information more patient-friendly. They would like to find ways to strengthen contacts with patient groups but are limited to their current funding resources and the ethical problems of accepting pharmaceutical grants for patient activities. The new legislation will require that all results of clinical trials will be made available online, however will it be in a format that is easily understandable by the general public which will need to be the case if patients are to understand them properly? Is this a role that more cancer leagues should be taking up in order to help patients?

Clinical Trials Directive in the Context of Patient Support Services, EORTC


Patients’ Rights to Cross-Border Healthcare Directive, Dirk van Steen, DG Sanco, and Paul Giepmans, European Health Management Association

The Cross-Border Healthcare directive will start to be implemented in October 2013 and will enable patients to travel within Europe for healthcare in different member states subject to certain conditions. The directive has three main aims:

  1. Help patients exercise their rights to reimbursement for health care received in another country:
  2. Provide assurance about safety and quality of cross-border health care and,
  3. Establish formal cooperation between health systems

Under the Directive, national contact points will be established in each country to provide information to patients about where to go for treatment and what the regulations are of the host country. All treatment received in a second country will be subject to the regulations of that country. The insurance system of the patient’s home country will only be requested to pay for treatment up to the sum of the actual cost at home, referred to as the price of the basket of care in the home state. Normally a patient will be required to pay for treatments up front then ask for reimbursements at home however this has raised concerns about who will in reality by able to afford cross-border healthcare given the price of many treatments, especially costly chemotherapy for example. In cases where a patient will need to stay overnight or receive planned treatments, prior authorisation will be required from their insurer or national government, whichever is responsible for covering health care costs in that country.  There are concerns about who would be held liable if anything goes wrong: the home insurer or the health care provider?

The implementation of the Directive is being led by the Committee on Cross-Border Healthcare. The ECL Patient Support Working Group will be monitoring the implementation of the directive in the relevant member states as a means to be better informed about the kinds of information to provide patients and their families about cross-border healthcare.

Dirk van Steen, Patients' Rights in Cross Border Healthcare Directive

Paul Giepmans, Implementation of the Cross Border Directive and Possible Implications for Patients 

Health Directive and possible implications
for patients




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