E-DRUG: Pharmacovigilance in Europe and patient safety: no to deregulation
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HAI Europe Press Release - February 1st 2008
Pharmacovigilance in Europe and patient safety: no to deregulation
A series of public health disasters (from thalidomide in the 1960s to
rofecoxib (Vioxx°) at the beginning of this century) have served to remind
us that effective pharmacovigilance is crucial for the protection of
citizens. Regrettably, the European Commission's proposed legislative
changes, published on 5 December 2007, pose a serious threat to public
health (1).
On the pretext of simplifying administrative procedures and "rationalising
the system", the Commission's proposals undermine the European
pharmacovigilance system and represent a major backward step for the
evaluation of medicinal products.
Pre-authorisation evaluations of medicines: helping to boost the
pharmaceutical firms' competitiveness while jeopardising patient safety
The European Commission's proposals will expose European citizens to
medicines that have been less thoroughly evaluated prior to authorisation.
Cutting corners on marketing authorisations. The Commission's stated aim is
to bring new medicines to market faster: "Earlier product authorisation
provides faster return on investment and, by reducing the cost of capital,
the total cost of product development is reduced".
To achieve this, the Commission proposes to undermine the pre-authorisation
evaluation by making conditional authorisations the norm rather than
awarding them only in exceptional circumstances, when there is an urgent
therapeutic need, as is currently the case.
To foster this shift and at the same time reassure the public, the
Commission is hiding behind the concept of "risk management systems", set
up and piloted by pharmaceutical companies. Unfortunately, these "risk
management systems" are not designed with patient safety as the key
priority.
Having medicines approved even when "therapeutic efficacy is insufficiently
substantiated". The Commission is proposing to delete "therapeutic efficacy
is insufficiently substantiated" from the list of reasons for refusing a
marketing authorisation or withdrawing a drug. However, only proven efficacy
can in fact justify exposing patients to adverse effects.
Furthermore, how can the authorities evaluate the risk-benefit balance of a
new drug if they do not have robust evidence of its efficacy?
Companies in charge of pharmacovigilance data: at every stage, at the cost
of patient safety
Entrusting the pharmaceutical companies with the task of gathering and
analysing data, issuing warnings and informing of their products' adverse
effects is unacceptable due to in-built conflict of interests. And yet the
Commission's proposals provide for the industry's intervention at every
level of decision-making, putting them in the position of both judge and
defendant.
Gathering risk evaluation data: minimal demands. The Commission is proposing
that post-authorisation studies and risk management plans can only be
requested by marketing authorisation committees under limited conditions,
and that the "risk management" system shall "be proportionate to the
identified and potential risks taking into consideration the information
available on the medicinal product". Unexpected or delayed adverse effects,
even when severe, are likely to be excluded from these systems, which are
not designed to identify rare long-term adverse effects.
Routine data gathering: centralisation and dilution of responsibilities. The
placing of pharmacovigilance responsibilities on the holder of the marketing
authorisation, the parent company, threatens to remove the responsibility
from those exploiting it at national level. The stipulations for data
recording and processing are unclear and do not allow for any external
monitoring.
Asking patients to notify directly to the companies adverse effects for
intensively monitored drugs is unacceptable.
The companies' pharmacovigilance systems cannot under any circumstances
become a substitute for national public pharmacovigilance systems which
unequivocally serve public interest.
Subcontracting data monitoring to pharmaceutical companies: danger. The
Commission plans to subcontract the monitoring of "all available relevant
data including data on Eudravigilance for signals of new or changing risks
(...)"to the firms, even though they are both judge and defendant. It will
also be up to the companies to alert the authorities in the event of new
data likely to affect their product's risk-benefit balance.
Data analysis: lack of transparency. According to the Commission's proposal
concerning the results of post-authorisation studies, it is up to the firms
labelling" or "might influence the risk-benefit balance of the medicinal
product". Subcontracting the interpretation of the data will result in the
drug regulatory agencies losing their authority and expertise.
The decision-making process: the payer calls the tune... The 2004 Regulation
strengthened the resources to be devoted to pharmacovigilance, insisting
that it should be publicly funded to guarantee its independence, specifying
that: "Activities relating to pharmacovigilance, (...) shall receive
adequate public funding commensurate with the tasks conferred" (Article 67.4
of Regulation 726/2004 (EC).
The Commission is planning to abolish this requirement for adequate public
funding and to allow pharmacovigilance to be directly funded by the firms
through the marketing authorisation fees paid to the agencies.
Information on adverse effects: blurring of roles. It is the authorities'
responsibility to process and interpret data, and to communicate the
results. At present, pharmaceutical companies are sending out "Dear Doctor"
letters, thus speaking on behalf of health agencies, which is likely to
result in abuses with companies trying to promote their medicines to health
professionals.
Redressing the balance
Medicines in Europe Forum, ISDB and HAI Europe strongly condemn the
Commission's proposals and call on it to re-focus its efforts and defend the
public interest, in accordance with its remit to protect European citizens
(Article 125 of the Treaty establishing the European Community) (2).
The above organisations' concrete proposals to strengthen pharmacovigilance
effectively fall into four categories:
- more stringent marketing authorisation criteria to ensure the approval of
medicines offering a genuine therapeutic benefit;
- guaranteeing the transparency of pharmacovigilance data, information and
decisions;
- granting authorities the means to be financially and morally independent
from the pharmaceutical companies;
- ensuring resources are in place for effective pharmacovigilance systems.
These proposals are set out in detail in their joint contribution to the
Commission consultation (2).
Contacts:
MiEF: Antoine Vial (europedumedicament@free.fr)
HAI Europe: Teresa Alves (teresa@haiweb.org)
ISDB: Maria Font (maria.font@ulss20.verona.it)
References :
1- European Commission - Enterprise and industry directorate-general "EU
pharmacovigilance: public consultation on legislative proposals" Brussels, 5
December 2007. Site internet : http://ec.europa.eu/enterprise : 49 pages.
2- Medicines in Europe Forum, HAI Europe, ISDB "Joint contribution to the
public consultation on pharmacovigilance in the EU of 5 December 2007"
January 2008. www.prescrire.org and www.isdbweb.org : 8 pages.
Teresa Leonardo Alves
European Coordinator
Health Action International (HAI) Europe
Jacob van Lennepkade 334T
1053 NJ Amsterdam
The Netherlands
Mobile:+31 6 246 867 71
Tel: +31 20 489 1864
Fax: +31 20685 5002
Email:teresa@haiweb.org
Web site: www.haiweb.org
Health Action International (HAI) is an independent, global network working
to increase access to essential medicines and improve their rational use.