Saatja: "Beata Stepniewska" <
[email protected]>
Saaja: "Beata Stepniewska" <
[email protected]>
Teema: RE: Urgent Medicines for Europe letter on dimethyl fumarate as a follow up of the Stending Commitee meeting and EC recent position
Kuupäev: 2023-06-27 11:50
Dear Ministers of Health,
Dear Heads of Medicines Agencies,
On behalf of the Medicines for Europe, I am recontacting you again to
express serious concerns with a new follow up regulatory action the European
Commission has undertaken in respect of generic marketing authorisations
(MAs) for dimethyl fumarate (DMF - a prescription medicine used to treat
relapsing forms of multiple sclerosis). The Commission seems to have
abandoned its previous intention to amend the generic DMF MA but now goes a
step further by proposing to revoke the MAs altogether.
In our view, this Commission proposal sets an extraordinary and dangerous
precedent, for the following reasons:
• There is no legal basis or justification for revoking generic DMF MAs. A
revocation of a MA is only reserved for cases in which there is a
substantial change in the risk-benefit assessment for a product, which is
clearly not the case here. In this case, a revocation, without hearing the
generic companies concerned, seems to be solely for enforcing the originator’s
position on an exclusivity which is a civil matter being treated in the
courts.
• The revocation will likely have retroactive effect, possibly triggering
potential criminal liability for MA holders in many Member States, which, as
a result, creates serious potential liability for all decision makers in
this process. Moreover, the lack of a transitional period would have an even
bigger impact on the availability of products on the market.
• The Commission fails to explain why it is taking a decision on a matter
that is still under judicial review – there is no need for the Commission to
intervene in a matter which is already the subject of a number of pending
court cases,
• In addition, this revocation sets a dangerous precedent in relation to
private civil disputes, on which the Standing Committee on Medicinal
Products for Human Use (‘Standing Committee’) seems to become a relevant
player, with an increased workload for its members as the national
authorities will have to deal with the consequences of a (retroactive)
revocation of the generic MAs.
• The Commission’s proposal, by containing several errors and ignoring the
2021 CHMP opinion, will also have immediate effects on patient access and on
public health budgets.
Please find more detailed justification in the attached letter.
Therefore, we respectfully call all the members of the Standing Committee to
reject this proposal until the ongoing court cases will be decided and the
matter is settled in the most appropriate way, ie. in Court. At least, the
written consultation should be stopped, and a meeting of the Standing
Committee should take place to discuss and vote all these issues.
On behalf of Adrian van den Hoven, Director General,
Beata Stepniewska
Beata Stepniewska
Deputy Director General & Head of Regulatory Affairs
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From: Beata Stepniewska <
[email protected]>
Sent: Wednesday, May 24, 2023 6:24 PM
To: Beata Stepniewska <
[email protected]>
Cc: HMA Permanent Secretariat <
[email protected]>; Doorduyn-v.d.Stoep, Kora
<
[email protected]>; CMDh Secretariat <
[email protected]>;
Giuliana Pennisi <
[email protected]>; Sergio Napolitano
<
[email protected]>; Adrian van den Hoven
<
[email protected]>
Subject: Urgent Medicines for Europe letter on dimethyl fumarate in advance
of the Stending Commitee meeting 30 May
Importance: High
Dear Ministers of Health,
Dear Heads of Medicines Agencies,
In advance of the Standing Committee meeting which will take place 30 May, I
want to share with you our serious concerns about the unprecedented and
unlawful Commission draft implementing decisions to amend marketing
authorisations of generic Dimethyl fumarate, a prescription medicine used to
treat 2 relapsing forms of multiple sclerosis, with an obligation to respect
retroactively the market protection period of the reference product
Tecfidera®.
Medicines for Europe respectfully calls all the members of the Standing
Committee on Medicinal Products for Human Use (‘Standing Committee’) to
1) request to be invited to the meeting of 30 May 2023,
2) carefully consider the legal arguments in the attached letter,
3) request an opinion of the CHMP according to article 10(4) Regulation No
726/2004, and ultimately,
4) supervise the Commission in its exercise of its implementing power, to
carefully assess and render a negative opinion about the draft implementing
decisions.
On behalf of Adrian van den Hoven, Director General,
Beata Stepniewska
Beata Stepniewska
Deputy Director General & Head of Regulatory Affairs
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Saadetud: 28.06.2023 11:15
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