Expec­ta­tions of a trans­parency offen­sive by the social secu­rity systems.

Familiar chal­lenges - new collab­o­ra­tive approach

Rising expenditure, the search for synergies in benefit assessments and the development of treatments for rare diseases are recurrent challenges for the social security systems when it comes to pharmaceuticals.

 

Whereas well-established health insurers with strong patient collectives in heavily populated countries have become highly proficient in negotiating prices with pharmaceutical manufacturers, small Member States with significantly smaller patient groups have little opportunity to position themselves in negotiations with the pharma industry. This results in a dependence on reference prices and benefit assessments in Europe.

 

In order to overcome these systematic dependencies and challenges, several Member States have formed purchasing alliances, such as the Valletta Group and BeNeLuxA.

Valetta Decla­ra­tion on price trans­parency

The Valletta Alliance intends to sign a declaration on price transparency of its members’ medicinal products in autumn 2019. Disclosure of individual prices will enable an exchange of information between countries, which is currently prohibited by confidentiality agreements with pharmaceutical manufacturers.

 

In addition to the initiative for price transparency, the Valletta Group wants to enter into research and development partnerships with pharmaceutical manufacturers. Discussions are planned to develop ideas on how the framework conditions for research into therapies for rare diseases can be optimised. Due to increasing antimicrobial resistance (AMR), the focus is currently on collaborative research into new antibiotics. See also article ‘The fight goes on’.

National impor­tance

Cooperation in the field of medicinal products at European level has many added values for the Member States. For example, the exchange of information to maintain and improve drug safety is very beneficial and is constantly being refined. The EU also creates added value for its member states with regard to research funding. In terms of pharmaceutical research, the EU competes particularly with the USA. The targeted distribution of EU research funds provides incentives for research into therapies for rare diseases.

 

Under certain circumstances, the joint development of standards and methods for Health Technology Assessment (HTA) can also benefit Member States (see article from April 2018).

 

An assessment of the additional benefit at European level must be kept separate from reimbursement and pricing decisions at national level. The latter are subject to national competence. Participation in a purchasing alliance such as the Valletta Group and BeNeLuxA is therefore voluntary and must be in line with the national competences of the social security systems.

 

Germany is not a member of any of these purchasing alliances. This is due to a unique situation in which the concept of strong self-governance means that the health insurance funds are responsible for ensuring that the provision of healthcare can be sustainably funded. National health insurance providers use their scope for autonomous horizon scanning of new drugs and analysis of demands from the insured collective to implement steering options in price negotiations.

 

The German Act on the Reform of the Market for Medicinal Products (AMNOG) stipulates that new pharmaceuticals must demonstrate an additional benefit. 

Back­ground infor­ma­tion

Valletta Declaration

The Valletta Declaration is a purchasing alliance currently comprising ten Member States (Malta, Portugal, Spain, Italy, Cyprus, Greece, Slovenia, Croatia, Romania, Ireland), representing approximately 160 million citizens. This equates to 31.5% of the EU population.

 

Objectives: Joint pricing strategy, horizon scanning, disclosure and participation in research and development costs. The Valletta Group sees itself as a stakeholder in the research of new therapies for rare diseases and aims to negotiate affordable and sustainable prices for new drugs.

 

BeNeLuxA:

BeNeLuxA is a purchasing alliance consisting of Belgium, the Netherlands, Luxembourg, Austria and Ireland (since 2018).

 

Objectives: Horizon scanning, joint HTA, exchange of information, joint price negotiations.