The European Commission’s work programme for 2016 entitled “No time for business as usual” has been published and mostly contains detailed plans to conduct business in the usual way.
Most of the foreseen initiatives were already well known and it seems that the Commission’s second year of mandate will be of a preparatory nature, aiming to provide a framework for more ambitious actions in the upcoming years.
There may be political reasons why health is not specifically mentioned on the EU agenda. Health does not fit comfortably within the scope of the EU treaties and with a UK referendum coming up, it may be that the Commission is keen to avoid providing ammunition to Eurosceptics on going outside their competences.
Of direct relevance to Members however are three items on the agenda:
New copyright rules: a new system of copyright will be announced in December which will outline a “vision for a more modern, more European approach on copyright to take account of the digital revolution.” No detail is given on what this entails however leaving little room for comment. This is an item to watch carefully however.
Health Technology Assessment (HTA): the programme announces the launch of the preparatory work and enhanced consultation on HTA “to improve the functioning of the single market for health products”.
Data protection: The data protection reform (Regulation and Directive) “should be agreed by the co-legislators by the end of the year”.
That an enhanced consultation on HTA takes place by itself is not particularly interesting but that it refers to “health products” makes it far more so. HTA only has a legal definition within the context of medicinal products and clarity is lacking on just how this applies to medical devices. A consultation on HTA when applied generally will provide an opportunity to clarify which of the multiple definitions of HTA and health technology are to be used and what is the plan moving forward.
A new goal deadline on the conclusion of Data Protection? Good. It has been at least a year since it was last promised that the GDPR would be finished before the end of the year.
The latest version of the Data Protection Regulation which would determine how every researchers processes data (storage, transfer, use, retention etc) is significantly more researcher friendly than its initial text due in part to advocacy by key health groups and also the VPH Policy Affairs Working Group and its adoption/implementation should make the rules on the use of health data clearer in all Member States.
The full text of Commission Work Programme can be found here.