European Medicines Agency

2023-05-09 22:00:00

Considering article 88-4 of the Constitution,

Having regard to Articles 114, 168 and 290 of the Treaty on the Functioning of the European Union,

Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 establishing a Community code relating to medicinal products for human use,

Having regard to Regulation (EC) n° 726/2004 of the European Parliament and of the Council of 31 March 2004 establishing Union procedures for the authorization and supervision of medicinal products for human use and establishing a European Medicines Agency,

Having regard to Regulation (EC) n° 297/95 of the Council of February 10, 1995 concerning the fees due to the European Agency for the Evaluation of Medicinal Products,

Considering the regulation (EU) n° 658/2014 of the European Parliament and of the Council of 15 May 2014 relating to the fees due to the European Medicines Agency for the conduct of pharmacovigilance activities concerning medicinal products for human use,

Considering the regulation (EU) n° 2019/6 of the European Parliament and of the Council of 11 December 2018 relating to veterinary medicinal products and repealing Directive 2001/82/EC,

Considering the regulation (EU) n° 2022/123 of the European Parliament and of the Council of 25 January 2022 on an enhanced role for the European Medicines Agency in crisis preparedness and management with regard to medicines and medical devices,

Considering the regulation (EU) n° 2022/2372 of the Council of 24 October 2022 on a framework of measures to ensure the provision of necessary medical countermeasures in the event of a crisis in the event of a public health emergency at Union level,

Having regard to the communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions presenting its pharmaceutical strategy for Europe, COM(2020) 761 final,

Having regard to the proposal for a regulation of the European Parliament and of the Council on fees and charges payable to the European Medicines Agency, amending Regulation (EU) n° 2017/745 of the European Parliament and of the Council and repealing Regulation (EC) n° 297/95 of the Council and Regulation (EU) n° 658/2014 of the European Parliament and of the Council, COM(2022) 721 final,

Having regard to the impact study of the European Commission accompanying the proposal for a regulation of the European Parliament and of the Council on fees and charges payable to the European Medicines Agency, amending Regulation (EU) n° 2017/745 of the European Parliament and of the Council and repealing Regulation (EC) n° 297/95 of the Council and Regulation (EU) n° 658/2014 of the European Parliament and of the Council, SWD(2022) 414 final,

Regarding the terms and conditions for revising the amount of royalties:

Considering that, to determine the amount of the fees and charges collected by the European Medicines Agency (EMA), the European Commission carried out an assessment of the charges of the EMA and the costs borne by the competent national authorities (CNA);

Considering that these royalties and fees are paid by companies producing medicinal products for human use and veterinary medicinal products in return for a service provided by the EMA;

Considering that the Member States of the European Union sit on the Board of the EMA;

Considering that, under the terms of Article 290 of the Treaty on the Functioning of the European Union, it is up to the legislator to define the scope of delegated acts;

Requests to precisely limit the list of elements that the Commission can invoke to justify a modification by delegated act of the amount of fees, rights and remunerations, and, for this purpose, to delete point e of Article 11 of the proposal Regulation on fees and charges due to the European Medicines Agency (COM (2022) 721 final);

Requests that the special report provided for in Article 10(6) of the said proposal for a regulation, which the Executive Director of the EMA might submit to the Commission, when he considers it relevant with regard to the expenditure and revenue of the agency, in order to recommend a change in the amount of a fee, right or remuneration following a significant variation in the corresponding costs and on the basis of which the Commission might justify such a change, or adopted by the Management Board of the EMA in order to allow the representatives of the Member States to take a position on the recommendations of this report;

Believes that the revision of the amount of royalties must be done in a transparent and concerted manner;

Requests therefore that, during the preparation of this special report, all stakeholders, including representatives of the pharmaceutical industry and the NCAs, be heard by the EMA;

Also wishes that this special report be published as soon as it is sent to the European Commission;

On the amount of royalties:

Considering the Commission’s desire to rationalize the system of fees and to reduce administrative costs such as those entailed by invoicing;

Considering that the Commission plans to maintain fee reductions for pediatric medicinal products and orphan medicinal products, as well as those granted to small businesses;

Considering that the pharmaceutical strategy for Europe presented by the European Commission aims in particular to ensure the availability of medicines and to guarantee the health sovereignty of the Union;

Considering the increase, envisaged by the proposal for regulation COM(2022) 721 final, in the amount of the fee relating to the evaluation of biosimilar medicinal products for initial marketing;

Considering the increase, envisaged by the said proposal for a regulation, in the amount of the annual pharmacovigilance fee relating to medicinal products for human use;

Considering the impact that animal health can have on human health;

Considering the increase, envisaged by the proposal for regulation COM(2022) 721 final, of the fee relating to a first marketing authorisation, the fee relating to a substantial modification of the marketing authorization and the annual fee for non-generic veterinary drugs;

Considering the creation of a new annual pharmacovigilance fee which covers all veterinary medicinal products marketed in the Union, regardless of the procedure for granting the marketing authorisation;

Considering that a period of six months is provided between the date of entry into force of the proposed by-law and its date of application;

Welcomes the removal of specific fees for minor variations – type IA and IB – of marketing authorisations;

Supports the initiative to propose royalties whose amount covers any dosage, any pharmaceutical form and any presentation, while calling for discussion of the induced increase in the amount of royalties;

Welcomes the maintenance of the fee reductions granted for pediatric medicines and orphan drugs, as well as the maintenance of the reductions granted to small businesses;

Hopes that the amount of royalties will be determined in such a way as to promote the achievement of the objectives of the pharmaceutical strategy for Europe, in particular with regard to the availability of medicines and the health sovereignty of the Union;

Requests therefore that the reduction of the annual fee relating to pharmacovigilance for generic medicines be increased to 50% and that the amount of the fee relating to the evaluation with a view to the first placing on the market of biosimilar medicines remains limited , preferably under a ceiling of 450,000 euros;

Also calls for a lower increase than envisaged in the amount of royalties affecting veterinary medicinal products to take into account the specificities of this market as well as the abolition of the annual pharmacovigilance fee for veterinary medicinal products which have not been subject to a centralized procedure;

Wishes to extend to 18 months the period between the date of entry into force of the text and its date of application for royalties relating to veterinary medicinal products, and to 12 months for royalties relating to medicinal products for human use;

Regarding EMA funding:

Considering that the EMA budget must be presented in balance;

Considering that the EMA’s revenue is made up of fees paid by companies and a contribution from the Union budget;

Considering that the share of public financing in the Union agencies dealing with health issues seems to be determined according to the financial capacities of the companies for which these agencies provide services;

Considering the share of public funds in other agencies also ensuring an evaluation mission aimed at enabling the marketing of drugs and a market surveillance mission;

Considering that the amount collected through royalties depends on companies’ strategies with regard to product marketing applications or their withdrawal;

Considering the Commission’s desire to strengthen the role of the EMA in preparing the Union for health crises and in managing them;

Believes that the share of public funds in EMA’s revenue should be increased in order to finance reductions in fees aimed at achieving the objectives of the pharmaceutical strategy, to ensure the stability of the EMA’s budget and to guarantee the financing of certain activities that do not directly benefit businesses;

Concerning the role of the ANC in the expertise:

Considering the essential participation of the CNAs in the work of the EMA;

Considering the essential contribution that can be made by an agency capable of offering quality expertise and support for the rapid provision of innovative medicines to patients;

Considering the essential role of the scientific advice provided by the agencies to marketing authorization applicants to support their applications;

Considering the recent increase in the costs of ANCs, due in particular to ever more specialized requests for expertise and inflation;

Considering that the assessment of the costs borne by the NCAs was carried out by the Commission before the COVID-19 pandemic and the inflationary surge following the Ukrainian conflict;

Calls for an overall revaluation of the amounts paid by the EMA to the CNAs to take account of inflation and the evolution of costs since 2018;

Would like the EMA to compensate the CNAs for the participation of their experts in the various working groups;

Recommend to maintain a minima at the current level the amount of royalties and amounts paid to NCAs for the scientific advice they provide;

Invites the Government to put forward these positions in the context of discussions in the Council.

1683968306
#European #Medicines #Agency