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