Transcript ISTRUZIONI PER PREPARARE POSTER DA ESPORRE A …

Agenzia Italiana del Farmaco - Italian Medicines Agency
Rome, ITALY
Increased transparency in EU pharmaceutical code
Published in The Lancet 2007 Jan 3;369(9556):88-90 (http://www.thelancet.com)
In the next few years, patients, health professionals, and regulators in
the European Union (EU) will face a challenge to implement the
culture of transparency that has been established by the new EU
Pharmaceutical Code (known as Review 2001).1,2 New methods have
been provided to allow the general public to access information
regarded as confidential until now, to promote the involvement of all
interested parties in the decision-making process.
However, a commitment to do postmarketing research should not
justify the approval of drugs that have not yet been investigated
fully. If premarketing authorisation studies are still necessary to
characterise the safety profile, these cannot be substituted by a
pharmacovigilance plan. Postauthorisation trials are a way to
reduce risks identified in premarketing clinical and non-clinical
studies.
For the first time, representatives of patients' and health
professionals' groups are appointed as members of the management
board of the European Medicines Agency (EMEA),2 so they are
empowered to express their opinion on strategies that will affect the
availability of innovative treatments. Diseases with wide social
effects—such as AIDS, cancer, neurodegenerative disorders, and
diabetes—are included in the work of EMEA, and now patients'
groups are actively included in policy-design activities. However,
potential disadvantages exist with such an approach—eg, the risk
that decisions are taken on the basis of public opinion, which can be
influenced easily by the mass media.
The assessment report of competent authorities that leads to the
authorisation of a new medicinal product and, in general, all minutes
of committees of national agencies must be publicly accessible.3 This
transparency allows the general public to understand the reasons
behind every decision, which will ensure consistency in the evaluation
process, because all stakeholders are able to become active in the
system, opening at any moment a discussion with competent
authorities. This step is additional to the process already initiated by
EMEA with the publication of European Public Assessment Reports
(EPAR).4,5 The experience gained with the Olivieri case,6 discussed
before the European Court of First Instance, confirms the importance
of this change. Olivieri challenged the opinion of the Committee for
Proprietary Medicinal Products after reading the EPAR on a medicine
and obtaining a revision of the previous opinion with a modification of
the conditions of the marketing authorisation. Now this possibility is
extended to all medicinal products and not solely to those approved
via the centralised procedure.
Regulatory authorities have to make all adverse reaction reports
available to the public,1 therefore overcoming the fact that package
leaflets and Summary of Product Characteristics are the only sources
of information on safety for health professionals and patients,
respectively. A dialogue between all stakeholders needs to be started.
The old attitude that patients and, in some cases, health
professionals do not need to understand because someone else
understands for them is definitely a part of the past.
Cases of drugs being withdrawn have been triggered mainly by
manufacturing authorisation holders rather than by regulatory
authorities.7 Therefore doubts have been expressed worldwide on the
capability of pharmacovigilance systems to detect safety signals and
to take swift action, and on the transparency of regulatory agencies to
provide effective information on drug safety.8 The new legislation1
provides the possibility to add conditions to marketing authorisations
to meet specific obligations by the applicant (ie, studies, registries,
etc) as part of a risk-management plan, and these conditions have to
be made public. The main implication of this legislative change is that
postmarketing safety studies, with periodic verification of the outcome
for established endpoints,9 become a full part of the
pharmacovigilance system and are no longer left to the initiative of
pharmaceutical companies. To keep patients and health professionals
informed of potential risks is very important in the early stages of
marketing of new medicines.
Despite the major advances made in ensuring transparency,
important issues remain unresolved and will need further legislative
initiatives. These issues include: provision of objective and
independent information to patients on medicinal products;
establishment of an independent body for pharmacovigilance; and
clarification of the notion of commercially sensitive information,
which companies still cannot disclose to the general public.
GP was the Italian representative at the pharmaceutical group of
the EU Council when the Pharmaceutical Code (Review 2001) was
finalised, during the Italian presidency of the Council. RBM
participated in the review of safety aspects of legislative proposals.
References
1. The European Parliament and the Council of the European
Union. Directive 2004/27/EC of the European Parliament and of the
Council of 31 March 2004 amending Directive 2001/83/EC on the
Community code relating to medicinal products for human use. April
30, 2004:
2. The European Parliament and the Council of the European
Union. Regulation (EC) No 726/2004 of the European Parliament
and of the Council of 31 March 2004 laying down Community
procedures for the authorisation and supervision of medicinal
products for human and veterinary use and establishing a
European Medicines Agency. April 30, 2004:
3. Garattini S. Confidentiality. Lancet 2003; 362: 1078-1079.
4. European Medicines Agency. Index of centrally authorised
medicinal products
5. Abraham J, Lewis G. Secrecy and transparency of medicines
licensing in the EU. Lancet 1998; 352: 480-482.
6. Judgment of the Court of First Instance (Fifth Chamber) on 18
December 2003 in Case T-326/99
7. Horton R. Vioxx, the implosion of Merck, and aftershocks at the
FDA. Lancet 2004; 364: 1995-1996.
8. Maxwell SR, Webb DJ. COX-2 selective inhibitors: important
lessons learned. Lancet 2005; 365: 449-451.
9. European Medicines Agency. ICH topic E 2 E: pharmacovigilance
planning (Pvp)—step 5, note for guidance on planning
pharmacovigilance activities (CPMP/ICH/5716/03). June, 2005:
Renato Bertini Malgarini*, Giuseppe Pimpinella**
* Pharmacovigilance Unit – **GMP Inspections Unit