Beate Hartinger-Klein: Patient benefit must be at the centre of all decisions
“Yesterday and today we have focused in much detail on two areas that in recent years have become increasingly important in terms of our health systems: security of supply of medicines and the use of modern electronic communication means in healthcare”,
Federal Minister Beate Hartinger-Klein and EU Commissioner Vytenis Andriukaitis explained at the informal meeting of health ministers in Vienna on 10 and 11 September 2018.
The Federal Minister presented a wide range of topics for discussion related to regulatory requirements for medicinal products.
Among other things, Hartinger-Klein identified potential for improvement in the structured exchange of information between regulatory authorities responsible for drug approval and other stakeholders in the healthcare system. This relates, for instance, to mechanisms that enable payers (in Austria, for example, the Main Association of Austrian Social Security Institutions; Hauptverband der Sozialversicherungsträger) to adapt as early as possible to the development of new product groups and products and to plan appropriately.
The Federal Minister and her colleagues continued by highlighting:
“The question of patient benefit is extremely essential in this context. How can we ensure, for example, that very expensive drugs used to treat critically ill patients do actually provide patient benefit that meets our expectations? It may thus be necessary to extend the essential criteria for the approval of these drugs to enable the provision of reliable information on new drugs. This should, however, affect neither duration nor costs of the authorisation process so that rapid supply of innovative products remains guaranteed.”
The health minister also addressed the topic of availability of medicines in Europe:
“Recent experience has shown that even in Europe, some medicinal products are in certain countries only brought to market with a delay or in some cases they are not brought to market at all. Therefore, we will have to consider measures that ensure supply security of medicinal products for all patients in the European Union.”
The Federal Minister stressed that it is thus necessary to “also direct research and development funding for medicines to those areas where less research is carried out due to smaller patient populations”.
Ahead of a Europe‑wide discussion on investment into digital health, Hartinger-Klein emphasised the importance of digitalisation in the healthcare system:
“There is no doubt that the provision and use of personal digital health data in diagnostics and therapy in the event of illness is in the public interest” and stressed that
“Every single member of a health profession, whether in medicine or in nursing, is better supported by the use of digital health data: if you know more about the patients to be treated, you can offer them a better diagnosis, therapy or care”.
In addition, the provision and use of digital health data is also of enormous importance for research and science.
“On the positive side we can ascertain that we, as member states of the European Union, are by no means at the beginning in the field of eHealth – or digital health”, stressed both the ministers and the representatives of the European institutions.
However, due to technical barriers, large parts of the existing digital infrastructure in the healthcare system are not, or only to a very limited extent, suitable for data exchange outside their respective organisations. It is thus necessary to identify concrete steps to be taken in order to overcome the barriers that undoubtedly still exist.
As a result of the discussions, the EU member states agreed to work closely with the services of the European Commission within the framework of the eHealth network that is already in place at EU level in order to develop a guideline for targeted Europe-wide promotion and investment programmes in the eHealth sector. The aim is to make the existing infrastructure of thousands of health service providers fit for the future.
The participants of the informal meeting furthermore agreed to make a joint effort to draw up a catalogue of requirements, standards and formats for the development of a Europe-wide interoperable digital infrastructure for health service providers.
At the end of the meeting, Hartinger-Klein underlined:
“The Presidency will inform the Employment, Social Policy, Health and Consumer Affairs Council in December 2018 of the outcome of the informal meeting and present some key messages. We hope to be able to enrich the debate at European level and present to a future European Commission some ideas on the challenges and proposals for solutions identified by the member states”.