The Committee on the Environment, Public Health and
Food Safety adopted an own-initiative report by Soledad
CABEZÓN RUIZ (S&D, ES) on the EU options for improving
access to medicines.
Members recalled that public health systems are
crucial to guaranteeing universal access to health care, a
fundamental right of European citizens. Health systems in the EU
face challenges such as an ageing population, the increasing burden
of chronic illnesses, the high cost of development of new
technologies, high and rising pharmaceutical expenses, and the
effects of the economic crisis on healthcare spending. These
challenges prompt the need for European cooperation and new
policy measures at both EU and national level.
The report called for national and EU-wide measures to
guarantee the right of patients to universal, affordable,
effective, safe and timely access to essential and innovative
therapies, to guarantee the sustainability of EU public healthcare
systems, and to ensure future investment in pharmaceutical
innovation.
Among other recommendations, Members called on the
Commission and the Member States to:
- reinforce the negotiation capacities of Member States
in order to ensure affordable access to medicines across the
EU;
- develop closer collaboration in order to fight
such market fragmentation and to work on shared criteria to
instruct price and reimbursement decisions at national
level;
- propose a new directive on transparency of
price-setting procedures and reimbursement systems;
- implement Directive
2011/24/EU on the application of patients rights in
cross-border healthcare in a fair way, avoiding limitations to the
application of the rules on reimbursement of cross-border
healthcare, including the reimbursement of medicine;
- foster R&D driven by patients unmet
needs, such as by researching new
antimicrobials, coordinating public resources for healthcare
research in an effective and efficient manner, and promoting the
social responsibility of the pharmaceutical sector;
- promote initiatives for guiding public and
private-sector research towards bringing out innovative medicines
for curing childhood illnesses;
- promote public and private-sector research into
medicines for female patients;
- adopt strategic plans to ensure access to life-saving
medicines; Members called in this regard, for the coordination of a
plan to eradicate hepatitis C in the EU;
- establish framework conditions in the areas of
research and medicine policy to be established in a way that
promotes innovation, particularly against diseases, such as
cancer, that cannot yet be treated to a satisfactory
degree;
- set up a framework to promote, guarantee and reinforce
the competitiveness and use of generic and biosimilar
medicines, guaranteeing their faster entry onto the market and
monitoring unfair practices;
- evaluate the implementation of the regulatory
framework for orphan medicines (especially as regards the
concept of unmet medical need, how this concept is interpreted and
what criteria need to be fulfilled in order to identify unmet
medical need), to provide guidance on priority unmet medical
need;
- promote ethical behaviour and transparency in
the pharmaceutical sector, especially regarding clinical trials and
the real cost of R&D, in the authorisation and assessment of
innovation procedure;
- observe and reinforce the EU competition
legislation and its competencies on the pharmaceutical market in
order to counter abuse and promote fair prices for
patients;
- propose legislation on a European system for health
technology assessment as soon as possible;
- increase cooperation between the Member States as
regards price-setting procedures.
The Commission is called upon to analyse the
overall impact of intellectual property on innovation on,
and on patient access to, medicines, by means of a thorough and
objective study, as requested by the Council in conclusions of 17
June 2016, and, in particular, to analyse in this study the impact
of supplementary protection certificates (SPCs), data exclusivity
and market exclusivity on the quality of innovation and
competition.
Lastly, Members urged the Commission and the Member
States to launch a high-level strategic dialogue with all
the relevant stakeholders, together with representatives of the
Parliament on current and future developments in the pharmaceutical
system in the EU, with the aim of establishing short-, medium- and
long-term holistic strategies for ensuring access to medicines and
for the sustainability of healthcare systems and a competitive
pharmaceutical industry, leading to affordable prices and faster
access to medicines for patients.