E-DRUG: New European Drug Legislation & World Health
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dear E-druggers,
On 20 May 2004 the new EU Directive on drug legislation became effective.
See
http://europa.eu.int/eur-lex/en/archive/2004/l_13620040430en.html
I have extracted below some articles that may have an impact on global
pharmaceutical issues.
They relate to export "control" of drugs, promoting R&D for neglected
diseases, cooperation with WHO, pharmacovigilance and, as reported earlier
in E-drug, a new procedure in which WHO can ask EMEA (now renamed "European
Medicines Agency") a scientific opinion about a new medicine which is
intended for use outside the EU. This might assist developing countries in
assessing the new (old) drugs that are now being developed for tropical and
neglected diseases. EMEA still has to set up procedures for this article to
work, however.
I have also attached the press release of EMEA about the implementation of
the new drug legislation.
regards
Wilbert Bannenberg, E-drug moderator
Email: wjb@planet.nl
Mobile +31-6-20873123
Tel +31-497-550713
Fax +31-497-550712
E-drug subscriptions/archives at http://www.essentialdrugs.org/edrug/
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http://europa.eu.int/eur-lex/pri/en/oj/dat/2004/l_136/l_13620040430en0001003
3.pdf
preambule 15 (on export, R&D for neglected diseases)
The Community is required, pursuant to Article 178 of
the Treaty, to take account of the development policy
aspects of any measure and to promote the creation of
conditions fit for human beings worldwide. Pharmaceutical
law should continue to ensure that only efficacious,
safe and top-quality medicinal products are
exported, and the Commission should consider
creating further incentives to carry out research into
medicinal products against widespread tropical diseases.
preambule 27 (on cooperation with WHO)
It is also necessary to reinforce the role of the Scientific
Committees in such a way as to enable the Agency to
participate actively in international scientific dialogue
and to develop certain activities that will be necessary,
in particular regarding international scientific harmonisation
and technical cooperation with the World
Health Organisation.
Article 27 (pharmacovigilance)
The Agency shall collaborate with the World Health Organisation
in matters of international pharmacovigilance and shall
take the necessary steps to submit to it, promptly, appropriate
and adequate information regarding the measures taken in the
Community which may have a bearing on public health
protection in third countries; it shall send a copy thereof to
the Commission and the Member States.
Article 58 (WHO procedure)
1. The Agency may give a scientific opinion, in the context
of cooperation with the World Health Organisation, for the
evaluation of certain medicinal products for human use
intended exclusively for markets outside the Community. For
this purpose, an application shall be submitted to the Agency
in accordance with the provisions of Article 6. The Committee
for Medicinal Products for Human Use may, after consulting
the World Health Organisation, draw up a scientific opinion in
accordance with Articles 6 to 9. The provisions of Article 10
shall not apply.
2. The said Committee shall establish specific procedural
rules for the implementation of paragraph 1, as well as for
the provision of scientific advice.
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In response, EMEA issued this press release on 3 May:
http://www.emea.eu.int/htms/hotpress/d1233204.htm
Press Release
EMEA 3 May 2004
New pharmaceutical legislation enters into force on 20 May 2004
Doc. Ref: EMEA/12332/04
The EMEA welcomes the publication of the new European pharmaceutical
legislation in the Official Journal of the European Union on 30 April 2004.
The revised legislative package introduces new responsibilities, a new
administrative structure, and a new name for the Agency.
Implementation of some parts of the new legislation starts 20 days after
publication, on 20 May 2004, with the remaining provisions coming into force
18 months later at on 20 November 2005.
Consequences for the EMEA
The revised Regulation and two Directives will have a significant impact on
the Agency. Elements of the new legislation that come into force in May 2004
include a reinforced role for the Agency in the provision of scientific
advice to companies, cooperation with the WHO in giving opinions for the use
of medicines outside the EU, opinions on the compassionate use of unapproved
medicines in Member States.
The Agency will be given a stronger role in the provision of information to
the patients and the public, including a mandate to develop a database of
all medicines approved in the European Union (�EuroPharm�). There are also
provisions for giving small and medium-sized companies administrative and
scientific support.
Provisions that will enter into force in November 2005 include conditional
approvals and fast-track reviews, in addition to an increase in the scope of
the centralised procedure.
The name of the Agency also changes to reflect its broader responsibilities,
to the European Medicines Agency. The acronym �EMEA� will continue to be
used. Other changes include:
Committee for Medicinal Products for Human Use replaces the Committee for
Proprietary Medicinal Products. The new Committee will be known as the CHMP.
Membership of the Committee changes from two to one member per Member State
(following EU enlargement this means 25 members) and in addition one member
from Iceland and Norway.
Committee for Medicinal Products for Veterinary Use replaces the Committee
for Veterinary Medicinal Products. The new Committee will continue to be
known as the CVMP. Membership of the Committee is similar to the CHMP.
There are no changes to the Committee for Orphan Medicinal Products (COMP).
A new Committee for Herbal Medicinal Products is created and is expected to
begin activity later in 2004. The new Committee will be known as the HMPC.
Composition of the Management Board changes from two to one member per
Member State, in addition to two representatives each of the European
Parliament and the European Commission. They are joined by two
representatives of patient organisations, one representative of doctors�
organisations and one representative of veterinarians� organisations. There
are a total of 33 members of the Board.
Next steps
The new Management Board will meet for the first time on 24 May 2004. One of
its first actions will be to consider the proposed composition of the CHMP
and CVMP. Under the new pharmaceutical legislation, the Management Board has
to be consulted on the composition of these two Committees before Member
States can appoint the members.
In order to allow enough time for the consultation process the CHMP meeting
scheduled for 25-27 May 2004 has been exceptionally postponed to 1-3 June
2004. The next CVMP meeting (11-13 May 2004) will be held in its current
form together with representatives from the new Member States acting as full
members. The June CVMP meeting will be held in its new composition.
--ENDS--
NOTES:
1. The EMEA was created in 1995 by Council Regulation (EEC) No 2309/93. The
new Regulation (EC) No 726/2004 will replace this Regulation. The new
Directives introduce amendments to the existing Community Codes on human and
veterinary medicines (Directives 2001/83/EC and 2001/82/EC).
2. This press release, together with other information about the work of the
EMEA, may be found on the EMEA web site at the following location:
http://www.emea.eu.int/
3. The full text of the new legislation can be found in the Official Journal
of the European Union on the following location:
http://europa.eu.int/eur-lex/en/archive/2004/l_13620040430en.html
Media enquiries only to:
Martin Harvey Allchurch
Tel. (44-20) 74 18 84 27, Fax (44-20) 74 18 84 09, E-mail: press@emea.eu.int
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