The MArS team wishes all a merry and peaceful Christmas and a great start into the New Year!!!
MArS attended the Medical valley Forchheim symposium on the market access pathway for new digital solutions (“apps”) into the statutory health care market. The new law will come into effect January 1 2020. Still open are the templates for the BfArM consultation and the price negotiation frame with the Head association of the statutory health insurance funds (GKV-SV). For the BfArM the regulations can be expected as the new law §33a para. 3 SGB V RefE is now publicly available. In case clinical evidence for a (patient) benefit is proven the app can be included in the BfArM registry / database, if that is not the case this can be provided within the first year of launch.
For the price negotiations MArS expects the regulation frame to be similar (but adapted) as within the AMNOG process. Core drivers will be the European prices (incl.out of pocket cost) as well as the clinical evidence on the product and comparable products. The template for the price negotiations are expected in the next few weeks. The arbitration board is not yet defined and built but is expected soon.
MArS offers the digital industry the experience in the process and contacts with German payers, the BfArM and especially with price negotiations with the GKV-SV. Core services to be provided will be Communication with payers, Pricing – planning, research, design, implementation and Price negotiation.
Sustainability is one of MArS’ core values! Hence MArS has defined four rules of behaviour on which all MArS members work, travel and live.
- “Notified Bodies”, which previously carried out the certification, are now accredited. Currently there are only 7 companies that are allowed to certify from 20.5.2020. The small number would delay the certification considerably.
- Previously, the state authorities were responsible for monitoring medical devices. From 25.5.2020, this will fall within the remit of the BfArm, i.e. the BfArm itself can withdraw medical devices from the market.
- British Standard Institution issues 2/3 of CE certificates in UK and is now accredited as Notified Body in Germany
- Legally binding: alternative compromise ideas with more scope for the member states are currently being developed for this purpose.
- Judicial redress: would an EU HTA assessment be an administrative decision or a preparatory measure to a decision?
- Scope: newly authorised medicinal products (proposal D/F: selection of 10 products per year); medical devices (proposal D/F: selection of some high-risk products)
- Dispute resolution in proceedings: is a simple or qualified (55 % of Member States with 65 % population) sufficient?
- Normally, the Council negotiates between Parliament and the Commission; this is the first time that parliament mediates between the Commission and the Council.
- Theoretically, failure would be possible, but would be a major setback for the EU.
- Agreement between Commission, EU Parliament and EU Council (“Trilogue”) expected in 2020
- Depending on how long the procedure will last, the question is which country as President of the Council will end the procedure: 1. HY 2020: Croatia; 2. HY: Germany