[Ip-health] European Parliament approves pharma law overhaul

[Greg Perry]

Message from the European Generic Medicines Association


In response to the note circulated below We would like to clarify for the
benefit of E-Drug readers
the outcome of the European Parliament's vote on October 23 in realtion to
its effecton generic medicines. In brief the European Parliament agreed to:

- A harmonised 8 years data exclusivity provision but coupled with the
restriction of production and marketing until 10 years after first
authorisation of the originator (It is important to note that the was passe=
d
by an overwhelming majority of MEPs).

- Grant an extra one year data exclusivity on the whole product if a new
indication of significant benefit was developed within the first 8 years.

- An improved text of the European Commission's own proposal for a Bolar
clearly covering provision of samples and export

- The right to developed and manufacture in the EU generic versions of EU
patent products for supply to a Country issuing a compulsory licence or
where there is no patent and a request has been made by the Country for suc=
h
imports to meet health needs.

- The establishment of a European Reference Product (euro-generic), which
would enable a generic to be marketed in any EU member state market as long
as the originator had been marketed in at least one EU Member State. At
present it is only possible to place generics on a national market if the
originator had been authorised in the country you a seeking market
authorisation.

- Maintain the European Commission's proposal that all new products (both
pharmaceutical and biotech) must got through the centralised procedure but
allows generic version of centrally approved originator products to use
either the Centralised Procedure (For access to all EU markets) or Mutual
Recognition Procedure (where marketing in limited number of countries).

- A definition of bio-generic but the  definition is very restrictive.

- Grant a period of 3 years data protection for OTC switching and new
indications for well established products involving substantial new data.
This protection covers the OTC switch or new indication only and not whole
product

- A strict definition of a generic medicine requiring complete chemically
identically (i.e. same salt, ester etc)

EGA is extremely concred with the last three points which we beleive will
cleary be used to prevent equivalbnt genrics from having market acess.


The Commission will now redraft its proposals. It does not need to
incorporate the views of the Parliament, and in fact even due to the large
majority for the 8 years compromise is expected to reject the parliament's
amendment in this area. Once The new proposals are published the Council of
Ministers (15 EURO member States ) will make their own amendments after
which the European Parliament will have second reading. The process is
complicated with the the Commission, Council and EP having to agree. A fina=
l
version of the law can not be expected for around 16 Months.

Greg Perry
Director General EGA


-----Original Message-----
From: ip-health-admin@lists.essential.org
[mailto:ip-health-admin@lists.essential.org]On Behalf Of James Love
Sent: mardi 5 novembre 2002 18:16
To: IP-Health list
Subject: [Ip-health] European Parliament approves pharma law overhaul


According to this Report, the European Parliment has endorsed an Article 30
"bolar" type exception to patent rights for Europe, but also to extend data
exclusivity to 10 years for every European country.  Jamie


"On generics, Liikanen is breaking with long-standing policy by allowing
producers to prepare for product launch before expiry of the patent on the
original, innovator drug.

"This change reflects case law established by the World Trade Organisation'=
s
intellectual property rights in the 2000 ruling in the "Bolar" case. The
changes entail aligning the data confidentiality protection enjoyed by the
patent holder. The protection period varies across Europe, between 6 years
in Ireland to 10 years in Germany and the UK--the period proposed as the ne=
w
EU norm. MEPs want to specify that generic producers could begin
preparations 2 years before the expiry of data protection. "This would allo=
w
products to be marketed the day after protection expires", said Grossetete.


-------- Original Message --------
Subject: European Parliament approves pharma law overhaul
Date: Tue, 5 Nov 2002 18:08:34 +0100
From: Martin Frid <mjfrid@hotmail.com>
Reply-To: Martin Frid <martin.frid@konsumentsamverkan.se>
Organization: Sveriges Konsumenter i Samverkan
To: <ip@tacd.org>

The Lancet: Science and medicine
http://www.thelancet.com/journal
European Parliament approves pharma law overhaul


Major reforms of European Union (EU) law on medicines, approved by the
European Parliament on Oct 23, are set to give wider powers to the
London-based European Medicines Evaluation Agency (EMEA).

Parliamentarians (MEPs) agreed to make the Agency responsible for approving
all drugs containing a new active ingredient. The intention of the changed
legislation is that new drugs should become available rapidly and
simultaneously throughout the 15 nations of the EU.

In a first reading vote, MEPs adopted 370 amendments. The final version of
the legislation will depend on whether the EU Council of Ministers reacts
those amendments--and how the two sides settle their differences.

Current EMEA approval is mandatory only for "innovative" drugs, notably
those produced as a result of biotechnology research. However, some
companies already opt for this "centralised" approval. MEPs rejected drug
industry claims that "competition" between the EMEA and national authoritie=
s
would be preferable to an EMEA monopoly.

Changes to EU rules on generics seek to accelerate their availability--and
ease cost pressures on health systems. The European Federation of
Pharmaceutical Industries and Associations (EFPIA) estimates that spending
on drugs by Europe's statutory health insurance systems in 2001 amounted to
E78=B75 billion (US$77 billion)--almost double the cost a decade earlier.

National regulatory bodies will retain powers to issue local authorisations
for generics and reformulations based on previously approved ingredients.
These approvals will continue to be recognised by other states, although
experience with this "mutual recognition" system since its introduction in
1995 has been mixed.

French MEP Fran=E7oise Grossetete, who is steering reform of the EU medicin=
es
code through its parliamentary stages, explains that states tend to invoke
their rights to demand fresh tests. "The other problem is that agencies wor=
k
at different rates. A new drug authorised in one country may not be
available in a neighbouring state", she says. Irish MEP Avril Doyle makes
the same point: "All patients should have equal access to state-of-the-art
drugs, regardless of where they live in Europe. [The EU] is either a single
market or it is not." Grossetete estimates that the EMEA will assess around
20 new substances a year, while national bodies will handle 200-300
applications.

Review of the regime at this time was foreseen in the 1995 legislation that
created the EMEA and established authorisation and surveillance rules to
replace cross-border cooperation arrangements. Expectations of EU
enlargement to 25 nations underscore the case for reform, according to
Grossetete: "Applying to 25 national administrations would be an intolerabl=
e
burden for smaller drug producers", she says.

European Commissioner Erkki Liikanen, responsible for EU industrial
innovation policy, points to EMEA's track record on completing evaluations.
The evaluations take an average of 180 days, compared with the 210-day limi=
t
set in EU rules. He also cites the success of EMEA encouragement for orphan
drugs. On risks that producers may be deterred by a centralisation, Liikane=
n
promises "concrete measures that would alleviate the burden on smaller
enterprises, for instance, a reduction in fees, direct scientific advice
from the EMEA, or administrative support".

Strasbourg's endorsement of centralisation was the major surprise in the Oc=
t
23 vote. MEPs rejected a recommendation from their own committee on health
and consumer policy, which favoured continuation of authorisation "duality"
between EMEA and state licensing bodies.

On generics, Liikanen is breaking with long-standing policy by allowing
producers to prepare for product launch before expiry of the patent on the
original, innovator drug.

This change reflects case law established by the World Trade Organisation's
intellectual property rights in the 2000 ruling in the "Bolar" case. The
changes entail aligning the data confidentiality protection enjoyed by the
patent holder. The protection period varies across Europe, between 6 years
in Ireland to 10 years in Germany and the UK--the period proposed as the ne=
w
EU norm. MEPs want to specify that generic producers could begin
preparations 2 years before the expiry of data protection. "This would allo=
w
products to be marketed the day after protection expires", said Grossetete.

MEPs see the centralised regime as a move toward a body with powers
analogous to those of the Food and Drug Administration--but without the
thousands of staff allocated to the American body. For now, the EMEA will
continue to "sub-contract" much technical evaluation work to specialists in
national laboratories.

But the European Parliament is firmly against following the US model of
deregulated drug advertising. Liikanen proposed a 5-year pilot project
allowing drug companies to offer disease-education information to patients
with asthma, AIDS, and diabetes--on grounds that this would counter
unvalidated material available to patients on the internet--predominantly i=
n
English.

But MEPs saw the idea as a step toward a US style of advertising
free-for-all--and a source of tension between doctor and patient. "Doctors
and pharmacists are the people best placed to give information on condition=
s
and their treatment", said Grossetete. However, Strasbourg has no objection
to governments or authorisation bodies setting up websites giving details o=
f
all licensed drugs.

Other parliamentary amendments seek to counter non-availability of
appropriately tested paediatric drugs, to encourage consideration of the
environmental impact of drugs, and to establish firm, EU-wide rules on the
independence of personnel employed by national bodies.

A major issue to be resolved concerns a Commission proposal to abolish the
current requirement for renewal of drugs authorisations at 5-year
intervals..
MEPs object on grounds that unforeseen side-effects can emerge in the first
years after authorisation. Their compromise suggestion is that
authorisations should be valid for an initial 5-year period and should then
receive indefinite extension, subject to satisfactory review. "But this
means a considered, scientific review involving evaluation of an updated
risk/benefit balance", said Grossetete. She claims that current renewals ca=
n
amount to little more than "rubber-stamping the original authorisation".

Arthur Rogers





--
------
James Love, Consumer Project on Technology
http://www.cptech.org, mailto:love@cptech.org
voice: 1.202.387.8030; mobile 1.202.361.3040


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