e-drug
[Top] [All Lists]

[e-drug] Pharmaceuticals: supervised information to patients should be allowed, says Liikanen

<26B54365D20CAF459EE9A201D2FF5EA50DA81B@a23171nt0101.a23171dom01.local>
Sender: owner-e-drug@usa.healthnet.org
Precedence: bulk
Reply-To: e-drug@usa.healthnet.org

Pharmaceuticals: supervised information to patients should be allowed,
says Liikanen

In short:
A day after the Council's final go-ahead for the new pharmaceuticals
package, the Enterprise Commissioner said its provisions on patient
information should be softened.


Background:
On 11 March, the Council adopted a series of legislative texts on
pharmaceuticals. The legislative package comprises a new regulation on
the authorisation and supervision of medicinal products, as well as two
directives relating to medicinal products for human use and veterinary
use.
The approval by Council follows the European Parliament's adoption of
the pharmaceuticals legislative package in second reading, on 17
December 2003 (see also EurActiv 18 December 2003
<http://www.euractiv.com/cgi-bin/cgint.exe/421008-531?714&1015=7&1014=p18123
a> ).

Issues:

The review of the EU's medicines legislation aimed to encourage
innovation and the development of new substances and therapies, to
enhance the competitiveness of the pharmaceuticals industry in the EU,
to simplify authorisation procedures and improve transparency.
The legislative package enhanced the operation of both the centralised
and decentralised authorisation procedures for the marketing of
medicinal products. Approval through the centralised procedure is now
mandatory for high-technology medicinal products such as gene therapy.

Positions:

Industry leaders, academia and representatives of the EU institutions
discussed the competitiveness of the EU's pharmaceuticals industry at
the Third European Business Summit, on 11-12 March.
Erkki Liikanen, Commissioner for Enterprise and Information Society,
said that the EU budget, which is currently agriculture and structural
funding-driven, should be replaced by a competitiveness-driven
allocation. Mr Liikanen highlighted the importance of the EU-wide
pooling of scientific talent. The Commissioner underlined that
experience has shown no correlation between fiscal incentives and a
businessman's decision to start research.

Mr Liikanen explained that the pharma review package improves current
legislation in two major ways: it has established a balance between
'innovation' and 'cost-containment' by creating harmonised rules on data
exclusivity across the EU and it has improved market access and cut red
tape.

Mr Liikanen said that industry should be able to inform patients on
request and under supervision by the EMEA (European Agency for the
Evaluation of Medicinal Products). The initial pharma review proposal
would have allowed a test case to provide information on drugs to treat
diseases such as AIDS, asthma and diabetes. This proposal was, however,
rejected by both Parliament and Council in first reading.
This issue has become increasingly more important due to mushrooming
international health websites with uncontrolled content. After the entry
into force of the pharma review package, this issue will be raised
again, concluded the Commissioner.

Tom McKillop, Chief Executive of AstraZeneca, complained that the once
world-leading European pharmaceuticals industry has been overtaken by
the US and other countries are also coming forward in the race,
including China and India. Sir Tom cited several causes for this
situation, including inadequate R&D spending in the EU, wide-spread
cost-containment policies pursued by Member State governments, delays in
market access as well as parallel trading, which, in his view, creates
an unattractive pharmaceuticals market. "Now is the time for political
courage and leadership," concluded Sir Tom.

Philippe Archinard, Chief Executive Officer of Innogenetics, pointed out
that the US success is related to a coherent policy approach, which has
resulted in bringing together highly-qualified researchers, excellent
research infrastructure, strong patent protection, and a favourable
business climate. Mr Archinard complained about the lack of a coherent
plan in the EU Member States to advance biotechnology. At the same time,
merely increasing the level of research spending would not change the
situation, he argued, as reform is needed in academic research. Further
steps are necessary in the EU towards a more favourable and supportive
public opinion on biotechnology.

Carlos Martinez, Professor at the Centro Nacional de Biotecnologica,
underlined this last point as he highlighted the four elements that
determine competitiveness: society, the scientific community, public
funding and the business sector. He said that regrettably US research
quality is generally much higher. Mr Martinez criticised the EU's
framework programme for focusing on a very limited number of strategic
priorities which are often revised as, in his view, the EU would need
long-term support for the development of core knowledge. In this, the
creation of a European Research Council would be beneficial, Mr Martinez
concluded.

Links:

Time-saving overview:
*       LinksDossier: Review of EU Pharmaceutical Legislation
<http://www.euractiv.com/cgi-bin/cgint.exe/421008-531?714&1015=9&1014=ld_pha
rmareview>
Official documents:
*       Council press release: Council adopts updated legislation on
pharmaceuticals
<http://www.euractiv.com/cgi-bin/cgint.exe/421008-531?714&1015=8&1014=UEEUIN
TPRESSDATAENMISC79378PDF>  (11 March 2004)
*       Council: Provisional minutes - Competitiveness Council (Internal
Market, Industry and Research)
<http://www.euractiv.com/cgi-bin/cgint.exe/421008-531?714&1015=8&1014=UEEUIN
TPRESSDATAENINTM79379PDF>  (11 March 2004)
*       Commission press release: Results of the Competitiveness Council
of Ministers, Brussels, 11th March 2004 Internal Market, Enterprise and
Consumer Protection issues
<http://www.euractiv.com/cgi-bin/cgint.exe/421008-531?714&1015=8&1014=EUROPA
EUINTIGUESTENKSHPACTIONGETTXTGTDOCMEMO04580RAPIDLGEN>  (12 March
2004)
*       European Agency for the Evaluation of Medicinal Products:
Website
<http://www.euractiv.com/cgi-bin/cgint.exe/421008-531?714&1015=8&1014=WWWEME
AEUINT>
EU Actors' positions:
*       European Business Summit: Website
<http://www.euractiv.com/cgi-bin/cgint.exe/421008-531?714&1015=8&1014=WWWEBS
UMMITORG>


Posted by
Spring Gombe
Health Actin International  Europe
Jacob van Lennepkade 334T
1053 NJ Amsterdam
The Netherlands

Phone  + 31 20 6833684
Fax + 30 20 6855002
e-mail: spring@haiweb.org <mailto:spring@haiweb.org>

--
To send a message to E-Drug, write to: e-drug@healthnet.org
To subscribe or unsubscribe, write to: majordomo@healthnet.org
in the body of the message type: subscribe e-drug OR unsubscribe e-drug
To contact a person, send a message to: e-drug-help@healthnet.org
Information and archives: http://www.essentialdrugs.org/edrug

<Prev in Thread] Current Thread [Next in Thread>
  • [e-drug] Pharmaceuticals: supervised information to patients should be allowed, says Liikanen, Spring Gombe <=