EMEA
functional transparency
- all members of EMEA committees and advisory boards will be obliged
to list their conflicts of interest on a yearly basis. This list
will be available to the public, but only on request from the Agency
(amendment 110 article 56-2-1, 1a and 2), making this obligation
ineffective;
- the Commission rejects the notion that the database on medicinal
products, for which EMEA will be responsible, should permit comparison
of drugs with similar indications (amendment 91 article 51-1-2-j);
- most of the amendments concerning EMEA transparency approved on
23 October 2002 by the European Parliament were based on European
Regulation 1049/2001, related to document databases and their ready
access by European citizens (especially amendments 38, 43, 51, 53,
79, 81, 87, 109 and 131). The Commission claims it accepts this
principle of document access, but considers that some documents
are already accessible and do not require any further obligations
(e.g. European Public Assessment Reports). The Commission states
that access to other documents will be guaranteed through a "separate
proposal by the Commission". Other documents, according to
the Commission, do not need to be grouped together in registers,
as they will already be accessible through a separate database.
This is the case of clinical trial registration, for example, but
the Commission's proposal would mean they would be separated from
the marketing authorisation data. Finally, the Commission proposes
creating "hierarchical access" to documents, depending
on whether the request comes from a pharmaceutical firm, a health
professional, or a member of the public (the case of adverse effects,
for example).
This complex system of access to public documents must be rejected,
and Regulation 1049/2001 must be strictly applied.
EMEA
functioning
- the Commission accepted the principle that rapporteurs in charge
of marketing applications should be able to seek the opinion of
patient organisations. However, while Parliament wanted to make
this obligatory, the Commission proposes simply that: "the
rapporteur may establish contact" (amendment 105 article 55-1-1).
This point has not yet been settled through the Commission-Council
compromise procedure;
the EU Parliament also recommended that presidents of EMEA scientific
committees be obliged to participate in meetings of the Agency's
management board. The Commission is seeking to make this participation
optional (amendment 118 article 58-3);
the Commission's first draft Regulation proposed that the centralised
marketing authorisation procedure (conducted by the European Medicines
Evaluation Agency) should become obligatory for new all drug substances.
This centralisation would avoid the use of the current mutual recognition
procedure, which is often less demanding and more secretive. Many
countries remain hostile to this proposal, which is still under
discussion;
representatives of patients, physicians and social security systems
will sit on the Agency's management board (amendments 116, 117 article
58-1 and 2). However, this point is still under discussion, one
country opposing the presence of social security representatives;
the Commission rejects the notion that patient representatives should
sit on the Agency's Advisory Board (amendment 119 article 59-1);
the Commission rejects the section of amendment 91 (article 51-1-2-j)
concerning the independent funding of the EMEA database, considering
that "it cannot be excluded that pharmaceutical firms do not
contribute financially to the development of this database".
along the same lines, the Commission refused the amendment aimed
at ensuring public funding of the Agency's core tasks (amendment
152 recital 17a). The Commission considers that "fees [paid
by companies] should serve to pay for the services carried out for
industry; the community contribution should serve to finance the
tasks of a public nature required of the Agency by the legislators
(
)". The Commission nonetheless recognises the need for
"adequate" public funding of pharmacovigilance activities,
"market surveillance" and "communication networks"
(amendment 121, article 60);
the marketing authorisation Committee (the current CPMP) will comprise
only one representative of each Member State (instead of two). The
Forum fears that the CPMP will be made up solely of administrative
representatives of national medicines agencies, and would prefer
to see one administrative and one scientific representative of each
country. If the Commission's concern is to avoid complicating meetings
after EU enlargement, the Forum proposes that the two representatives
of each member state have a single vote.
Evaluation
of medicinal products
- the Commission rejected an amendment stipulating that the rationale
underlying marketing authorisations should be explained for each
therapeutic indication, arguing that this is already the case. The
Forum would find it more reassuring if this practice became obligatory
in the Regulation;
- the Commission rejected amendments calling for a minimum of 90
days for the scientific assessment of marketing applications during
the standard centralised procedure, and for possible extension of
this period in special cases (amendments 175 and 45 articles 6-3-1a,
1b, 1c and article 1362a, 2b). The Commission considers this to
be a "detail" that can be dealt with through EMEA internal
procedures. Yet the Forum feels that such a measure must be explicitly
stated in the Regulation in order to guarantee the quality of scientific
evaluation;
- the Commission accepts in principle the amendment referring to
the principle of comparative efficacy (of a new drug relative to
available treatments) (amendments 4 and 100, recital 11 and article
53a). The Commission even recalled that the Council of Health Ministers
had underlined (on 29 June 2000) the importance of identifying drugs
with added therapeutic value.
But, according to the Commission, "this evaluation should not
be conducted in the context of the marketing authorisation for which
it is agreed that the fundamental criteria should be retained".
In the Commission's opinion the only important criteria for judging
a new drug are its quality, safety and efficacy. It therefore proposes
a simple "survey" of methods used by Member States to
determine the added therapeutic value of new drugs. But these methods
have been known for years, and such a survey would appear pointless.
The Medicines in Europe Forum would like to see a system that encourages
firms to provide comparative information on their drugs. At the
very least, it should be officially stated, when appropriate, that
marketing application files do not contain such data. Whatever the
state of the application, the Agency's assessment report should
contain the CPMP's opinion on the added therapeutic value of the
drug in question, or simply state that it cannot be determined,
as a matter of basic transparency.
Pharmacovigilance
- patients will be invited to notify adverse effects to health professionals,
and, possibly, to the relevant authorities (amendment 54 article
20-3). This point is still under discussion, however, as several
Member States do not want to be encumbered by patient notifications;
- the Commission did not accept that all patient leaflets bear words
to the effect: "newly authorised medicinal product; please
report any adverse effects" for the first five years (amendment
42 article 13-3a), under the pretext that it does not want patients
to notify adverse effects directly to the companies, but only to
Agencies and health care professionals (see above). But this has
nothing to do with the need to call patients' attention to the fact
that new drugs must be closely monitored. Patient notification is
already accepted practice in many countries (New Zealand, Sweden,
United Kingdom);
- The EU Parliament recommended that EMEA actively collate pharmacovigilance
data on new drugs during the first two years on the market; the
Commission prefers to make this measure optional, under certain
conditions, but for a 5-year period (amendment 64 article 24-3a);
- the Commission did not accept that the EMEA database should contain
pharmacovigilance data (amendment 157 article 51-2), under the pretext
that a specific pharmacovigilance database is planned. This simply
confirms the Commission's ploy to maintain a complicated information
maze that would hinder public access.
Compassionate
use
- drugs for compassionate use will remain free of charge for the
patients concerned (article 73-6). However, the relevant article
must be worded more precisely: if not, responsibility for funding
such treatments is likely to be passed around drug companies, member
States and EMEA like a hot potato;
- the draft Regulation offers no guarantees that compassionate use
programs will be effectively created for all patient groups in need.
Patient representatives and health professionals must therefore
be able to ask national agencies and EMEA to intervene.
Data
protection
- the Commission rejected an amendment stating that some member
states could be exempted from the planned 10-year data protection
(some states only protect data for 6 years) (amendment 46 article
138). Several countries want this point to be dealt with at the
same time as the corresponding item in the draft Directive.
Developing
countries
- the Commission rejected all amendments calling for active solidarity
with poor countries (only safe and effective drugs of high quality
should be exported; research on diseases prevalent in the poorest
countries should be stimulated; co-operation on pharmaceuticals
should be developed; etc.) (amendments 7, 8, 26 and 94). The Commission
considered that such proposals were beyond the scope of the Regulation.
The Forum demands that these points at least be mentioned in the
recitals of the final text, in order to show that Europe is truly
concerned by this important issue.
©La revue Prescrire for the Medicines
in Europe Forum 1 March 2003
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