EU-konsultasjon om avgifter til legemiddelovervåking
Public Consultation on the Introduction of Fees for Pharmacovigilance to be charged by the European Medicines Agency
Åpen konsultasjon igangsatt av Kommisjonen 20.6.2012 (frist 15.9.2012)
Nærmere omtale
BAKGRUNN (fra konsultasjonsdokumentet engelsk utgave)
INTRODUCTION
The European Medicines Agency ('EMA') is an EU body with its own legal personality. EMA is responsible for coordinating the scientific resources put at its disposal by the Member States for the evaluation, supervision and pharmacovigilance of medicinal products. It is amongst the few EU Agencies which are fee-earning. Under Article 67(3) of the Regulation (EU) No 726/2004 ('the Regulation'), EMA's revenue shall consist of an EU contribution and fees charged for undertakings for obtaining and maintaining EU marketing authorisations and for other services. Currently, approximately 85% of EMA's revenues derive from fees, and the remaining 15% from the EU budget.
The pharmaceutical legislation on pharmacovigilance has recently been revised through the adoption of Regulation (EU) No 1235/2010 of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 (hereinafter referred to as 'the Regulation') and Directive 2010/84/EU of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC (hereinafter referred to as 'the Directive'). Pharmacovigilance relates to the detection, assessment and prevention of adverse effects of medicinal products. The new legislation will strengthen the EU pharmacovigilance system and improve the protection of public health. The new legislation also provides that industry is to be charged fees by EMA for the conduct of pharmacovigilance activities, whereas the previous (2004) wording of Article 67(4) of the Regulation provides that these activities are to be publicly funded.
Only medicinal products which have been authorised in accordance with EU legislation either by the European Commission or by the national competent authorities ('NCAs') in the Member States ('MS') can be placed on the market in the EU. EU-wide marketing authorisations ('MA') are issued by the European Commission (on the basis of a scientific opinion of EMA) according to the centralised procedure. Hereinafter, such products are referred to as centrally authorised products ('CAPs'). A MA can also be issued by an NCA for its own territory (pure national marketing authorisation). As regards MAs in several MS, there are two procedures: (i) mutual recognition procedure where a medicinal product is first authorised in one MS under the national procedure, and in the case where subsequent applications for MAs are filed in other MS, the latter agree to recognise the validity of the first MA; and (ii) decentralised procedure where the MA applications are submitted simultaneously in different MS and for which one MS acts as reference MS (carrying out the scientific evaluation). Products authorised by the NCAs under any of the latter three procedures are hereinafter referred to jointly as 'noncentrally authorised products' ('non-CAPs').
Given that the new pharmacovigilance legislation provides a significantly greater role for EMA in the area of pharmacovigilance, i.e. irrespective of how the medicinal products have been authorised (therefore including both nationally and centrally authorised products), it is justified that EMA will charge fees also where nationally authorised products (non-CAPs) are involved (Article 67(3) of the Regulation) . It should also be borne in mind that while the new pharmacovigilance legislation lays down certain obligations on the industry, the activity of the regulatory authorities in the area of pharmacovigilance (notably the detection of safety signals, assessment of these signals and regulatory follow-up) constitute a service to the industry. EMA will have certain functions in pharmacovigilance activities, due amongst other things to the creation of a new scientific committee at EMA, the Pharmacovigilance Risk Assessment Committee ('PRAC'). Additionally, coordination tasks or IT support tasks, such as the enhancement of the EudraVigilance ('EV') database, have been assigned to the Agency.
The Commission's proposal of 10 December 2008 to amend the pharmacovigilance legislation was accompanied by a Financial Statement whereby all costs related to activities resulting from the legislative proposal are to be recouped through fees. This proposal was amended by the Council and the European Parliament during the legislative process, while the financial statement was not modified. This is important, as some additional tasks were entrusted to EMA that were not foreseen in the Financial Statement and these tasks are to be covered by fees. Even if the Financial Statement accompanying the legislative proposal on pharmacovigilance from 2008 is now outdated, it provides some insight into what types of fees for pharmacovigilance activities were foreseen. Indeed, it laid down the following 4 types of fees for the following activities:
- referrals (estimation 20/year at 72,800€),
- Periodic Safety Evaluation Reports ('PSURs') assessed (1000/year at 6,100€),
- Post-authorisation Safety Studies ('PASSes') (study assessments 300/year at 6,100€) and
- Risk management assessments (100/year at 12,100€).
The final proposal for introduction of fees for pharmacovigilance will be accompanied by its own financial statement.
The pharmacovigilance legislation will become applicable in July 2012 and therefore, it is urgent to enable EMA to charge fees for the fulfilment of its pharmacovigilance tasks. Fees payable to the EMA are laid down in Council Regulation (EC) No 297/95 ('Fees Regulation'). These fees are normally subject to annual adjustments to the inflation rate under Article 12(5) of the Fees Regulation, and hence also the fees for pharmacovigilance should be subject to such adjustments. This Concept Paper deals with pharmacovigilance fees, and therefore the comments in this public consultation should relate to this topic only and not in general to the Fees Regulation. It should be noted that the Commission will proceed, after having put forward fees for pharmacovigilance, as a second step, with an overall revision of the Fees Regulation which will be preceded by another public consultation.
Given that the pharmacovigilance legislation only concerns medicinal products for human use, there can be no introduction of pharmacovigilance fees for veterinary products in this revision. A Commission proposal to amend in addition certain provisions of the pharmacovigilance legislation is currently going through the legislative process Finally, it should be borne in mind that the existing legislation provides for various fee incentives for small and medium sized enterprises ('SMEs') for applicants and holders of MAs for CAPs. However, most of the fee incentives relate to the pre-authorisation stage and, for example, the SMEs currently pay the full annual fee to EMA. It is nevertheless important to ensure that any amendment to the current legal framework regarding the payment of fees by SMEs to EMA for pharmacovigilance does not undermine these incentives.
This Concept Paper will be disseminated as widely as possible to all stakeholders and EMA will also send it to all SMEs which are included in the SME register.
INTRODUCTION
The European Medicines Agency ('EMA') is an EU body with its own legal personality. EMA is responsible for coordinating the scientific resources put at its disposal by the Member States for the evaluation, supervision and pharmacovigilance of medicinal products. It is amongst the few EU Agencies which are fee-earning. Under Article 67(3) of the Regulation (EU) No 726/2004 ('the Regulation'), EMA's revenue shall consist of an EU contribution and fees charged for undertakings for obtaining and maintaining EU marketing authorisations and for other services. Currently, approximately 85% of EMA's revenues derive from fees, and the remaining 15% from the EU budget.
The pharmaceutical legislation on pharmacovigilance has recently been revised through the adoption of Regulation (EU) No 1235/2010 of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 (hereinafter referred to as 'the Regulation') and Directive 2010/84/EU of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC (hereinafter referred to as 'the Directive'). Pharmacovigilance relates to the detection, assessment and prevention of adverse effects of medicinal products. The new legislation will strengthen the EU pharmacovigilance system and improve the protection of public health. The new legislation also provides that industry is to be charged fees by EMA for the conduct of pharmacovigilance activities, whereas the previous (2004) wording of Article 67(4) of the Regulation provides that these activities are to be publicly funded.
Only medicinal products which have been authorised in accordance with EU legislation either by the European Commission or by the national competent authorities ('NCAs') in the Member States ('MS') can be placed on the market in the EU. EU-wide marketing authorisations ('MA') are issued by the European Commission (on the basis of a scientific opinion of EMA) according to the centralised procedure. Hereinafter, such products are referred to as centrally authorised products ('CAPs'). A MA can also be issued by an NCA for its own territory (pure national marketing authorisation). As regards MAs in several MS, there are two procedures: (i) mutual recognition procedure where a medicinal product is first authorised in one MS under the national procedure, and in the case where subsequent applications for MAs are filed in other MS, the latter agree to recognise the validity of the first MA; and (ii) decentralised procedure where the MA applications are submitted simultaneously in different MS and for which one MS acts as reference MS (carrying out the scientific evaluation). Products authorised by the NCAs under any of the latter three procedures are hereinafter referred to jointly as 'noncentrally authorised products' ('non-CAPs').
Given that the new pharmacovigilance legislation provides a significantly greater role for EMA in the area of pharmacovigilance, i.e. irrespective of how the medicinal products have been authorised (therefore including both nationally and centrally authorised products), it is justified that EMA will charge fees also where nationally authorised products (non-CAPs) are involved (Article 67(3) of the Regulation) . It should also be borne in mind that while the new pharmacovigilance legislation lays down certain obligations on the industry, the activity of the regulatory authorities in the area of pharmacovigilance (notably the detection of safety signals, assessment of these signals and regulatory follow-up) constitute a service to the industry. EMA will have certain functions in pharmacovigilance activities, due amongst other things to the creation of a new scientific committee at EMA, the Pharmacovigilance Risk Assessment Committee ('PRAC'). Additionally, coordination tasks or IT support tasks, such as the enhancement of the EudraVigilance ('EV') database, have been assigned to the Agency.
The Commission's proposal of 10 December 2008 to amend the pharmacovigilance legislation was accompanied by a Financial Statement whereby all costs related to activities resulting from the legislative proposal are to be recouped through fees. This proposal was amended by the Council and the European Parliament during the legislative process, while the financial statement was not modified. This is important, as some additional tasks were entrusted to EMA that were not foreseen in the Financial Statement and these tasks are to be covered by fees. Even if the Financial Statement accompanying the legislative proposal on pharmacovigilance from 2008 is now outdated, it provides some insight into what types of fees for pharmacovigilance activities were foreseen. Indeed, it laid down the following 4 types of fees for the following activities:
- referrals (estimation 20/year at 72,800€),
- Periodic Safety Evaluation Reports ('PSURs') assessed (1000/year at 6,100€),
- Post-authorisation Safety Studies ('PASSes') (study assessments 300/year at 6,100€) and
- Risk management assessments (100/year at 12,100€).
The final proposal for introduction of fees for pharmacovigilance will be accompanied by its own financial statement.
The pharmacovigilance legislation will become applicable in July 2012 and therefore, it is urgent to enable EMA to charge fees for the fulfilment of its pharmacovigilance tasks. Fees payable to the EMA are laid down in Council Regulation (EC) No 297/95 ('Fees Regulation'). These fees are normally subject to annual adjustments to the inflation rate under Article 12(5) of the Fees Regulation, and hence also the fees for pharmacovigilance should be subject to such adjustments. This Concept Paper deals with pharmacovigilance fees, and therefore the comments in this public consultation should relate to this topic only and not in general to the Fees Regulation. It should be noted that the Commission will proceed, after having put forward fees for pharmacovigilance, as a second step, with an overall revision of the Fees Regulation which will be preceded by another public consultation.
Given that the pharmacovigilance legislation only concerns medicinal products for human use, there can be no introduction of pharmacovigilance fees for veterinary products in this revision. A Commission proposal to amend in addition certain provisions of the pharmacovigilance legislation is currently going through the legislative process Finally, it should be borne in mind that the existing legislation provides for various fee incentives for small and medium sized enterprises ('SMEs') for applicants and holders of MAs for CAPs. However, most of the fee incentives relate to the pre-authorisation stage and, for example, the SMEs currently pay the full annual fee to EMA. It is nevertheless important to ensure that any amendment to the current legal framework regarding the payment of fees by SMEs to EMA for pharmacovigilance does not undermine these incentives.
This Concept Paper will be disseminated as widely as possible to all stakeholders and EMA will also send it to all SMEs which are included in the SME register.