Print
See related documents
Resolution 2071 (2015)
Public health and the interests of the pharmaceutical industry: how to guarantee the primacy of public health interests?
1. During the 20th century, humankind
saw the most spectacular medical advances in its history. Scientific progress
helped us to identify the origin of countless illnesses and to develop
treatments which have significantly improved the population’s state
of health. The pharmaceutical industry has played an indisputable role
here by investing massively in research and development for new
medicines. It continues to do so and is therefore one of the key
players in the health field and at the same time a very important
sector of activity in many countries.
2. For a long time, questions have been raised about the possible
negative effects of the interaction between the pharmaceutical industry
and health sector stakeholders. This interaction may well give rise
to conflicts of interest, have an influence on the knowledge and
behaviour of the players involved and result in biased decisions.
In its Resolution 1749
(2010) “Handling of the H1N1 pandemic: more transparency
needed”, the Parliamentary Assembly had expressed its concern at
the risk of conflicts of interest among experts involved in sensitive
health-related decisions.
3. Despite the considerable progress made in preventing and dealing
with conflicts of interest, this is still today largely a matter
of hit-and-miss. By means of a self-regulation policy, the pharmaceutical
industry is now adopting a much more ethical approach and legislation
lays down rules in this area. However, self-regulation is not binding
and the implementation of legislation leaves much to be desired.
4. Research and development for new therapeutic molecules is
a costly and lengthy process. In return for this investment, pharmaceutical
companies benefit from an intellectual property right on the molecules
they develop, protected by a patent. This innovation model has led
to the discovery of thousands of medicines. However, more and more
voices are now being heard arguing that this is not the optimal
approach in public health matters.
5. In recent years, in spite of the increase in the number of
new medicines placed on the market, there have been very few that
present a real therapeutic benefit, satisfying real health needs.
In addition, we have seen an upsurge in the price of medicines,
allegedly justified by the cost of research and development, which nonetheless
remains opaque and broadly disputed. The exorbitant price of cancer
and hepatitis C treatments is of particular concern. Public health
systems are faced with constant cost increases in this area, jeopardising their
ability to fulfil their role.
6. In the light of these considerations, the Assembly calls on
the Council of Europe member States:
6.1. with regard to interaction between the pharmaceutical
industry and health sector players, to:
6.1.1. incorporate,
into the curriculum for health care professionals specific, mandatory training
to foster awareness of the influence of pharmaceutical promotion
and how to respond;
6.1.2. introduce a mandatory levy on the promotional activities
of the pharmaceutical industry and use it, inter
alia, to finance a public fund to be used for the independent
training of health care professionals;
6.1.3. place an obligation on pharmaceutical companies to declare
their linked interests with all health sector players, to make these
declarations accessible to the public, and to establish an independent
authority responsible for monitoring this matter;
6.1.4. ensure absolute transparency regarding the linked interests
of experts working with the health authorities and make sure that
persons with a conflict of interest are excluded from sensitive
decision-making processes;
6.1.5. ensure that health-related decisions, including decisions
on criteria for defining illnesses and thresholds for treatment,
are taken on the basis of individual and public health considerations and
are not profit-driven;
6.1.6. introduce strict regulations governing the movement from
a position in the public sector to one in the private sector (and
vice versa), between the health authorities and the pharmaceutical
industry;
6.1.7. increase the funding of patients’ associations from public
funds in order to avoid over-reliance on private funding;
6.2. with regard to research and development for new therapeutic
molecules, to:
6.2.1. oblige pharmaceutical companies to
ensure absolute transparency regarding the real costs of research
and development, particularly in relation to the public research
portion;
6.2.2. adopt a stricter marketing authorisation policy, by:
6.2.2.1. introducing criteria such as added therapeutic value (in
relation to existing treatments), or a “need clause”, implying that
a drug must also be assessed in relation to medical need;
6.2.2.2. making it mandatory to publish the results of all clinical
tests relating to the medicine for which authorisation is being
requested;
6.2.2.3. where appropriate, considering restricting reimbursement
by the social security system to only those medicines which satisfy
such criteria and requirements;
6.2.3. ensure that medicines whose effectiveness has been established
remain on the market by having recourse, where necessary, to mandatory
licences in return for the payment of royalties;
6.2.4. set up a public fund to finance independent research geared
to unmet health needs, including in the field of rare and paediatric
diseases.
7. The Assembly calls on member States to prohibit any agreement
between pharmaceutical companies which aims to delay, without medical
justification, the marketing of generic medicines.
8. The Assembly calls on member States to impose dissuasive penalties
for any illegal practices carried out by pharmaceutical companies,
where appropriate by imposing fines of a given percentage of their
turnover.
9. In order to ensure the viability of health systems and the
accessibility of affordable and innovative medicines in the long
term, the Assembly calls on the World Health Organization to put
forward alternatives to the current patent-based pharmaceutical
innovation model.
10. Lastly, the Assembly calls on the pharmaceutical industry,
including companies and associations, to step up its efforts to
increase transparency and co-operate more closely with the public
authorities in the health sector.