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Patients have a voice – Five highlights from the Eupati Nordic Workshop

As a member of the EUPATI Finland steering group, Hanne Juuti from DRA was involved in programme planning and assisted in the organisation of the event.


Participants included Finnish patients and representatives of research organizations, hospitals, Nordic patient organizations, and the pharmaceutical industry.

In future, patient involvement and the patients’ “voice” will have an increasingly important role. Patients are already represented in the EMA’s expert groups when decisions on marketing authorisation are made. The EU’s new clinical trials regulation puts an obligation on pharmaceutical companies to involve patients more integrally in trial planning . As regards health technology assessments (HTA) and introduction and reimbursement status processes, patient involvement is still at its early stages; however, listening to patients would provide valuable information to support decision-making in this area as well.

Organized by Eupati Finland the Eupati Nordic Workshop held on 24 to 25 February 2020 focused on patient involvement and the sharing of best practices. Participants included Finnish patients and representatives of research organizations, hospitals, Nordic patient organizations, and the pharmaceutical industry.

Concerns voiced at the event included issues such as, how to ensure that patients have received appropriate education for their role? And on the other hand, as the need for representatives of patients increases, patients will come from somewhere, but from where, sent by whom, and whose agenda will they promote? Researchers and authorities also need to be educated on how to involve patients, and in particular on the potential benefits of patient involvement.

Patient participation is associated with great opportunities but also with challenges. At the Eupati Nordic Workshop, the following five themes emerged in particular.

1. Innovative therapies

There will be major changes in pharmaceutical research and assessment of medicines when medicinal products entering the marked are supported by ever smaller amounts of research data. The EMA has already responded to this by means of regulatory flexibility regarding orphan medicines and accelerated procedures. However, price regulatory authorities are currently baffled. They are not able to manage the uncertainty which the scarcity of research data brings to models. Complete new ways of placing products in the market with reimbursement status and sharing related risks are needed.

2. Cross-border treatments

Mobility within the Nordic region as regards approved treatment or participation in clinical trials is often difficult. Pharmaceutical companies do not have the resources to for example conduct clinical trials separately in each country. However, hospitals are somewhat reluctant to send patients abroad. This is because of unclarity with regard to who is responsible for treatment in another country and how monitoring of treatment should be arranged.

3. EU clinical trial portal

In future, evaluation of clinical trials will be conducted in a centralised manner in the EU, and trials will be collected in a joint open portal where for example patients can search for trials related to their condition. In the process, one of the countries where the study is conducted plays the role of a reference member state as it were, while the others provide comments on and evaluate their national part.

4. Prioritisation and ethical issues

One of the topics discussed at the event was prioritisation from the moral, ethical and value-based perspective. Decision-making should be based on identical criteria and be transparent throughout the country. The participants highlighted for example that from the moral point of view, age must not be a factor for prioritization, yet medically it may be one. On the other hand, the therapeutic indication recorded in the summary of product characteristics may serve a decision-making tool, even though groups other than those already studied could benefit from the treatment.

5. Nordic cooperation in health technology assessment

Assessment of hospital-only medicines in the joint FINOSE (Finland, Norway, Sweden) project continues. Combination therapies where iv therapy administered at the hospital is combined with tablet-based therapy in the outpatient setting have proved to be particularly challenging. Such therapies cannot be assessed as separate therapies, which has complicated models. In Finland, problems assessment arise in particular from the two-channel funding of hospital care and outpatient care.