WRITTEN QUESTION P-2143/01 by Minerva Malliori (PSE) to the Commission. Delays in EMEA approval of drugs.
Date: 2001-07-10
Institutions: European Parliament, Provisional data
Subjects: Community certification, European Medicines Agency, market approval, medicinal product

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(2002/C 40 E/214)

WRITTEN QUESTION E-2136/01

by Daniel Varela Suanzes-Carpegna (PPE-DE) to the Commission

(17 July 2001)

Subject: Imports of Venezuelan and Peruvian preserved sardines into the EU

In his reply to my Written Question E-1198/00 (1), Commissioner Fischler said that the Commission had
asked the importing Member State (Germany) to ensure strict compliance with Council Regulation (EEC)
2136/89 (2) of 21 June 1989 laying down common marketing standards for preserved sardines and that
(cid:145)a number of practices not in conformity with Community legislation were corrected as a result(cid:146). The
Commissioner added that (cid:145)however, since the situation did not appear to be entirely satisfactory, the
Commission then initiated infringement proceedings against the importing Member State. These are still in
progress(cid:146).

It is clear that the Commission is making efforts in this field and it would be welcome if it could keep
Parliament informed of the outcome.

Will the Commission say what progress has so far been made with the abovementioned infringement
proceedings?

Will it provide information on any other infringement proceedings in progress or pending in relation to
the regulation in question?

Will it give details of the volume and country of origin of Community imports of preserved sardines since
1 January 2001?

(1) OJ C 89 E, 20.3.2001, p. 15.
(2) OJ L 212 E, 22.7.1989, p. 79.

Answer given by Mr Fischler on behalf of the Commission

(5 September 2001)

Concerning the infringement procedure initiated by the Commission, the German authorities(cid:146) reply to the
letter of formal notice provided information showing that they had rectified the infringements that had
given rise to the complaint. In the absence of further information from the complainants, therefore, the
Commission decided at its meeting of 18 July 2001 that there was no need to continue the procedure. The
complainants have been informed of the Commission(cid:146)s intention to close the procedure.

The Commission has not initiated any other infringement procedures against other Member States.

The statistics on imports into the Community of preserved sardines, sardinellas and pilchards by country of
consignment have been sent directly to the Honourable Member and to Parliament(cid:146)s Secretariat.

(2002/C 40 E/215)

WRITTEN QUESTION P-2143/01

by Minerva Malliori (PSE) to the Commission

(10 July 2001)

Subject: Delays in EMEA approval of drugs

There has been a growing number of reports in the European press recently concerning the time-
consuming procedures used by the European Agency for the Evaluation of Medicinal Products (EMEA) to
approve new drugs. Access to new drugs is a serious matter given its direct bearing on the protection of
public health in the EU.

What is the procedure for approving and placing a new drug on the market in the EU?

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How much time is estimated and how much is actually required to complete the approval process?

Is the Commission examining the possibility of speeding up the procedure for approving new drugs
already in circulation outside the Union which many of the population could take for common seasonal
illnesses?

Answer given by Mr Liikanen on behalf of the Commission

(26 September 2001)

Regarding the first question, there are two procedures in the current Community system for obtaining a
marketing authorisation in the Community:

(cid:129) The mutual recognition procedure for national authorisations is applicable whenever an application
for marketing authorisation for a medicinal product concerns two or more Member States. Under this
procedure, the scientific evaluation is carried out by one Member State, called the (cid:145)Reference Member
State(cid:146) in 210 days. The other Member State (cid:129) where the same application has been lodged (cid:129) then has
90 days to recognise the authorisation granted by the (cid:145)Reference(cid:146) Member State.

(cid:129) The centralised procedure is currently mandatory for all medicinal products resulting from biotech-
nology (Part A of the Annex to Council Regulation (EEC) No 2309/93) (1), and optional for certain
innovative products (Part B of
the same Annex). The procedure leads to a single marketing
authorisation which is valid for all Member States following scientific evaluation by the European
Agency for the Evaluation of Medicinal Products (2) (EMEA).

Concerning more particularly the centralised procedure, companies have to send applications directly to
the EMEA. The evaluation of the file is completed and an opinion as to whether to grant or not an
authorisation is issued within 210 days of the receipt of a valid application. The Agency then has 30 days
to forward its opinion to the Commission and the Commission has 30 days to prepare a draft decision,
i.e. to turn the Agency opinion into a binding decision for all Member States. The draft decision is
submitted to the Standing Committee on Medicinal Products for Human Use, where Member States have
fifteen days to return their linguistic comments and thirty days for scientific and technical ones. When the
opinion is favourable, the draft decision is forwarded to the Commission for adoption. It is then notified to
the Member states and the marketing authorisation holder and is also published in the Official Journal of
the European Community. Marketing authorisations granted via this procedure are valid for five years.
Applications for extension must be made to the EMEA three months before this five-year period expires.

Five years after its creation this procedure is already very popular since, apart from the medicinal products
for which it is mandatory, it has been largely used for medicinal products for which it is optional (3).
According to a study carried out on behalf of the Commission (4), government ministries, professional
organisations and patient organisations generally believe that availability of new medicines has increased
since the creation of the EMEA. They also confirm that this authorisation procedure is not overly time-
consuming, given that many checks have to be carried out in terms of qualify, efficacy and safety control.

The problem of drug accessibility lies very often, at a later stage, with the length of time. Some Member
States need to agree on prices and reimbursement rates, after the marketing authorisation has been
that Directive 89/105/EEC (5) provides for strict deadlines for pricing and
granted, despite the fact
reimbursement approval. However,
to
Article 226 (ex Article 169) of the EC Treaty in case Member States do not respect the provisions of this
Directive.

the Commission is undertaking legal proceedings pursuant

Despite the success of the current system, the Commission is of the view that the authorisation procedures
can be improved to better keep up with scientific progress. Proposals on reviewing the existing legislation
were recently launched focusing on increasing the availability of new and innovative medicinal products. It
is proposed that procedures are being accelerated, simplified and modernised (cid:129) and thus are becoming
less bureaucratic. The centralised procedure is accessible to more types of new medicines. The text includes
many progressive provisions like the creation of a (cid:145)fast-track(cid:146) registration procedure, the possibility of
granting conditional authorisations, subject to additional clinical studies, availability of medicinal products
in advance of authorisation on a (cid:145)compassionate use(cid:146) as well as data protection incentives.

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they are already
Regarding new drugs already in circulation outside the Community, the fact
authorised in another third country does not imply that the EMEA or the reference Member State in the
context of the decentralised procedure are obliged to proceed to their approval. The evaluation of new
drugs has to be considered on a case by case basis and will only be essentially accelerated if those fall
within the categories for which the (cid:145)fast-track(cid:146), conditional or (cid:145)compassionate use(cid:146) authorisations have been
proposed.

that

(2)
(3)

(1) Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization
and supervision of medicinal products for human and veterinary use and establishing a European Agency for the
Evaluation of Medicinal Products (OJ L 214, 24.8.1993).
Instituted by Regulation (EEC) No 2309/93.
From 1995 to May 2001, 171 authorisations have been granted under this procedure for medicinal products for
human use and 26 for medicinal products for veterinary use.
(cid:145)Evaluation of the operation of Community procedures for the authorisation of medicinal products(cid:146), Evaluation
carried out on behalf of the European Commission, Cameron McKenna (cid:129) Andersen Consulting, available on http://
pharmacos.eudra.org.

(4)

(5) Council Directive 89/105/EEC relating to the transparency of measures regulating the pricing of medicinal products
for human use and their inclusion in the scope of national health insurance systems (called the (cid:145)transparency(cid:146)
directive) (OJ L 40, 11.2.1989).

(2002/C 40 E/216)

WRITTEN QUESTION E-2144/01

by Jo Leinen (PSE) to the Commission

(18 July 2001)

Subject: Orphan Drug Directive (cid:129) marketing authorisation for the treatment of Fabry(cid:146)s Disease

When drafting and discussing the Orphan Drug Directive, nobody apparently considered the possibility
that two products for the same indication could be submitted at the same moment. This however seems to
have happened in July 2000 for Fabry(cid:146)s Disease. Both products received from the COM (Committee for
Orphan Medicines) an orphan drug status. Moreover, they were both given by the CPMP (Committee for
Proprietary Medicinal Products) a (cid:145)positive opinion(cid:146) for granting marketing authorisation on 29 March
2001. Since Directive EC65/65, the criteria on which a pharmaceutical product has to be evaluated for
marketing authorisation are quality, safety and efficacy. The efficacy of a pharmaceutical product has to be
proven on the basis of clinical studies with validated endpoints for clinical benefits, and not based on non-
validated so-called (cid:145)surrogate markers(cid:146). In this case, one product, Replagal, showed clinical benefits by
reducing pain, improved renal function and a reduction of the cardiac mass. Another product, Fabrazyme,
has not been able to document clinical benefits, but only effect on a non-validated (cid:145)surrogate marker(cid:146). This
latter fact has also been stated by the company itself as well as its principal investigator.

How can a product receive a positive opinion for marketing authorisation in Europe, based on non-
1.
validated surrogate markers, when it has failed to demonstrate clinical benefits? Even more remarkable,
how could this happen when the other product has documented significant clinical benefits, with a
probably better safety profile?

2.
How can it be in the interests of patients with a debilitating orphan disease to be treated with a
product approved on a non-validated surrogate marker, when they have to wait for the outcome of future
studies to know if there may be a clinical benefit, especially in the case where another product is
scientifically proven to have clinical benefits?

3. Why has the letter from TKT Europe 5S of December 21 2000, dealing with this matter and sent to
your Directorate c/o Pharmaceuticals and Cosmetics Unit, never officially been answered, with regard to
the use of non-validated surrogate markers? One might assume that the transparency of the process could
be served with an early answer?

4.
Does this positive opinion from the CPMP for a product with effects only on a non-validated
surrogate marker, reflect a shift in policy on allowing marketing authorisations in Europe, and if so, why
has this not been publicly communicated to the industry and medical community?