Commission proposes 'fairer' mixed fee system to cover EMA's pharmacovigilance costs
This article was originally published in SRA
Following strong criticism over its 2012 proposals for EU pharmacovigilance fees, and suggestions earlier this year that it was considering a flat fee system instead, the European Commission has gone for a compromise: a mixture of a flat fee and a range of individual payments for procedures such as safety referrals and periodic safety update reports (PSURs)1-4.
A long-awaited draft regulation just adopted by the commission says that an annual flat fee of €60 ($78) would be payable to the European Medicines Agency for each product on the market, while there would be specific fees for individual services. Safety referrals, for example, would attract a fee of €168,600, while fee reductions and exemptions would be available for certain companies and types of products.
The commission sees the proposal, which still has to undergo scrutiny by the European Parliament and Council of Ministers, as a great improvement on the system initially outlined in a concept paper last year. That proposal was slammed by almost all stakeholders who responded to the public consultation in June to September 2012, with comments such as "disproportionate", "excessive" and "unfair"5.
As the commission drily notes in the preamble to the proposed regulation, "in general, the comments were rather negative, notably as regards the amounts proposed for the fees", which were seen as too high and disproportionate to the tasks being performed. It was also pointed out that there was a risk of double charging at the agency and member states, while the generics industry said the proposed fee levels would unfairly affect companies with a large portfolio of products with well established safety profiles.
A new, dedicated pharmacovigilance fee system is needed because the current EMA fees regulation does not include any provisions on specific charges for pharmacovigilance activities, and there is no adequate funding for such activities at EU level, which also means that member state rapporteurs are not currently remunerated for their assessment work within the EU procedures.
Moreover, under the new pharmacovigilance legislation the EMA has taken on certain tasks regarding nationally authorized medicines, as well as strengthened competences for centrally authorized drugs, which all adds to the burden on an already financially overstretched agency.
The new structure, which involves much lower fees than those put forward in 2012, is considered by the commission to be "the most transparent, cost-based, activity-based and proportionate way of setting the new fees". The aim is still for the fee revenues to cover all costs incurred by the EMA in conducting its pharmacovigilance activities.
Fee details
Under the proposal, companies will have to pay the EMA a flat fee of €60 for each product with a marketing authorization (based on listings in the EudraVigilance (xEVMPD) product database). This fee is intended to cover the costs of general pharmacovigilance activities by the agency, such as those relating to the maintenance of the EudraVigilance database and the registry of PSURs, adverse drug reaction management and signal detection, and literature monitoring. An invoice for the fee will be issued to companies by 31 January of each calendar year, and the fee must be paid within 30 days of receipt.
Individual fees will be charged for the following specific tasks: assessment of PSURs, post-authorization safety studies (PASS), and referrals triggered by safety concerns. Where two or more marketing authorization holders are involved in these procedures, the fee will be split among them.
The EMA will remunerate rapporteurs for work carried out in certain cases, for example where a member state has appointed a member of the EMA's Pharmacovigilance Risk Assessment Committee who acts as rapporteur for a PSUR or PASS assessment or a referral procedure. This remuneration is included in the calculation of the fee for each activity.
Fee levels
The various fees that would be payable by companies under the regulation, together with the EMA's remuneration to the rapporteur, are as follows:
- flat fee: €60 per marketing authorization
- safety referral: €168,600 (rapporteur €45,100)
- PASS assessment: €43,000 (rapporteur €18,200)
- PSUR assessment: €19,500 (rapporteur €13,100)
These fee levels are considerably below those put forward last year: up to €267,400 for referrals, for example, and up to €80,300 for PSUR and PASS assessments.
In keeping with the aim of producing an equitable, risk-based fee system, a range of exemptions and reductions is suggested. For example, the flat fee will not apply to centrally authorized medicines, because companies marketing these products already pay an annual maintenance fee to the EMA.
Small and medium-sized firms will pay only 60% of the flat fee and the procedure-specific fees, while "micro-enterprises" will be exempt from all fees.
Companies marketing products such as generics and well-established use medicines will have to pay only 80% of the flat fee, but they will be subject to the full fee for specific procedures.
Financial implications
An annex to the draft regulation lays out the expected level of pharmacovigilance activities each year together with the cost estimates. For example, the commission expects some 600 PSUR procedures each year, at a total cost of around €11.3 million (€3.4 million in agency costs, and €7.9 million for the rapporteurs), and 35 PASS assessments at €1.5 million (€900,000 in agency costs, €600,000 for rapporteur costs). It also foresees some 40 pharmacovigilance referrals a year, at a total cost of €6.7 million (€4.9 million and €1.8 million).
The flat fee has been calculated on the basis that the total estimated costs to the EMA for conducting its general pharmacovigilance activities will be €19.1 million.
This gives a total cost estimation for pharmacovigilance activities of €38.5 million, of which the EMA services account for €28 million and rapporteur remuneration for €10.5 million.
In order to keep track of how the fee system is working, the EMA executive director and the commission will each year provide the agency's management board with a cost breakdown for the previous year and, where necessary, the level of the fees and rapporteur remuneration will be adjusted.
References
1. European Commission, Proposal for a Regulation on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use, 26 June 2013, http://ec.europa.eu/health/files/fees_2013/comm_native_com_2013_472_proposal_for_a_regulation_en.pdf
2. European Commission, Impact Assessment, accompanying document to the proposal for a Regulation on the fees payable to the European Medicines Agency (EMA) for the conduct of pharmacovigilance activities in respect of medicinal products for human use, 26 June 2013, http://ec.europa.eu/health/files/fees_2013/comm_native_swd_2013_234_impact_assesment_en_v3_p1_734050_en.pdf
3. European Commission, Executive summary of the impact assessment, accompanying the document proposal for a Regulation on the fees payable to the European Medicines Agency (EMA) for the conduct of pharmacovigilance activities in respect of medicinal products for human use, 26 June 2013, http://ec.europa.eu/health/files/fees_2013/comm_native_swd_2013_235_impact_assessment_summary_en.pdf
4. Pharmacovigilance flat fee proposal on track; EMA changes expectations on management of ADRs from non-interventional studies, Scrip Regulatory Affairs, 12 June 2013
5. Universal opposition to EU pharmacovigilance fee plan, Scrip Regulatory Affairs, 6 December 2012
Byline(s):
| Author | Name | Ian Schofield |
| | ||
| Image |
|