[Ip-health] Joint Press Release Parliament's stand against conflicts of interest: Is it enough to ensure medicines safety?

Press HAI Europe Press at haieurope.org
Tue May 10 07:08:03 PDT 2011

Brussels, 10 May 2011


Parliament's stand against conflicts of interest: Is it enough to ensure
medicines safety?


Health Action International (HAI) Europe, Medicines in Europe Forum
(MiEF) and the International Society of Drug Bulletins (ISDB)
congratulate the European Parliament on calling for the European Court
of Auditors to evaluate the performance of the European Medicines Agency
(EMA). The EMA's handling of conflicts of interest between its
scientific experts, its in-house personnel and its former employees, and
the pharmaceutical industry will go under the microscope from now until
the end of June. However, will this audit be enough to prevent competing
interests from influencing medicines regulators?


The mandate of European medicines regulators is to guard the safety,
efficacy and quality of medicines sold in Europe. Decisions about
medicines should be made by impartial experts and based on the most
objective evidence. Nonetheless, regulators' close ties with drug makers
calls into question the independence of their decisions. 


Pharmaceutical companies pay a fee to the Agency to have their medicine
evaluated in order to obtain marketing approval. As these payments
constitute the majority of the EMA's budget (81,3%), the European
medicines regulatory agency finds itself dependent on industry
financing. An ever-increasing share of the EMA's budget comes from
services and scientific advice provided to industry applicants, thereby
questioning the Agency's objectivity.


"The Agency needs to be weaned off the fee-for-service relationship that
it currently has with pharmaceutical companies," said Katrina
Perehudoff, Project Officer at HAI Europe.


To guarantee the EMA's independence, any direct financial relationship
between the Agency and the pharmaceutical industry should be avoided.
This could be achieved by channelling application fees to the European
Commission and by financing the Agency exclusively through the EU


"It is unacceptable that the very agency evaluating medicines safety and
efficacy is dependent on funding from the manufacturers it controls.
Only when regulators, such as the European Medicines Agency, are
intellectually and financially independent from the pharmaceutical
industry can we be assured they are acting in the public interest," said
Jorg Schaaber, President of ISDB.


The EMA provides a public service as the guardian of medicines safety,
and it is, first and foremost, accountable to European citizens. HAI
Europe, MiEF and ISDB call on the Agency to strengthen its transparency
policy and demonstrate its political will to put citizens first, and to
protect public health.


Health Action International (HAI) Europe is an independent European
network of health, consumer and development organisations working to
increase access to essential medicines and improve their rational use. 

More info: www.haieurope.org. Contact: teresa at haieurope.org.


International Society of Drug Bulletins (ISDB), founded in 1986, is a
world wide Network of bulletins and journals on drugs and therapeutics
that are financially and intellectually independent of pharmaceutical
industry. Currently, ISDB has 79 members in 40 countries around the
world. More info: www.isdbweb.org. Contact: press at isdbweb.org.


Medicines in Europe Forum (MiEF), launched in March 2002, covers 12
European Member States. It includes more than 70 member organizations
representing the four key players on the health field, i.e. patients
groups, family and consumer bodies, social security systems, and health
professionals. Such a grouping is unique in the history of the EU, and
it certainly reflects the important stakes and expectations regarding
European medicines policy. Admittedly, medicines are no simple consumer
goods, and the Union represents an opportunity for European citizens
when it comes to guarantees of efficacy, safety and pricing. Contact:
pierrechirac at aol.com

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