Flat pharmacovigilance fee a possibility in EU: a radical change from original proposals - update
This article was originally published in SRA
Drug companies in the EU could be looking at paying the European Medicines Agency a flat fee – presumably annually – to cover the agency’s responsibilities under the new EU pharmacovigilance legislation.
The EMA is “pretty keen to identify a flat fee”, EMA head Guido Rasi announced. The agency is working with the European Commission on the matter and the commission is “very interested” and is indeed encouraging the EMA to identify some solution, Professor Rasi reported at the opening session of the 12th European Generic medicines Association Regulatory and Scientific Affairs Conference in London on 17 January.
The EGA – and EFPIA, representing the R&D-based industry – welcome the fact that the question of fees is being revisited.
The commission’s original proposals for a fee structure to fund the new pharmacovigilance tasks that are to be carried out by the EMA involved specific fees for specific activities; the plans met with almost universal opposition when they were issued last June1-4. “Everyone criticised” the proposals, Professor Rasi conceded, and the EMA now recognised that it had to “work in another direction”. The flat fee would be like a “maintenance fee”, Prof Rasi said.
The impact assessment relating to the fees should be “finalized in a couple of weeks”, according to senior commission official Andrzej Rys. After this “we will propose a new fee structure”, he told the meeting. The impact assessment is the prerequisite for putting forward a legislative proposal; the aim is for this to be submitted to the European Parliament and Council of Ministers “in Spring 2013”, said Dr Rys, who heads the health systems and products directorate (directorate D) within the commission’s health and consumers directorate general (DG Sanco).
Pressed for further detail, Prof Rasi said while the EMA was being encouraged by the commission to explore the possibility of a new model, it was premature to say at this stage how the final version of a flat fee model might look. However, ideally, it would cover “everything” – including at least the cost to national competent authorities of integrating their pharmacovigilance systems and databases to the centralised system.
While the fees are critical to the EMA being able to fulfil its new responsibilities under the legislation, it is likely to be a couple of years before they are in place. In the meantime, the additional activities that are required of the EMA and of national competent authorities under the legislation still have to be funded. This leaves the possibility that, in the case of national competent authorities at least, they introduce charges unilaterally to cover their additional responsibilities.
Original fee proposals
The commission’s original proposals for a fee structure to fund the new pharmacovigilance tasks that are to be carried out by the EMA were contained in a "concept paper” that was out for comment between 18 June and 15 September last year. A number of specific fees for pharmacovigilance activities were put forward, as follows:
- periodic safety update reports (PSURs): €40,150 for products authorized for less than two years, and €80,300 for those approved for more than two years;
- post-authorization safety studies (PASS): €80,300;
- referrals: from €80,300 to a maximum of €267,400;
- administration fee: €500; and
- pharmacovigilance annual service fee: a maximum of €1,000 per year per product.
The responses, published on the commission's website in December, were peppered with terms such as "disproportionate", "idealistic", "excessive" and "unfair". Representatives of industry (brand, generic and over-the-counter), regulators and consumer organizations bemoaned a lack of transparency, failure to base fees on the work performed and an over-reliance on industry funding.
They said there was no clear justification for the 10-fold hike in some of the fee levels originally proposed in 2008, nor was there any real clarity as to how the various pharmacovigilance tasks, and the fee income relating to them, would be apportioned among the various regulators. Many companies claim their fee budgets would rise by 50% or even double if the proposals were implemented as they stood.
Industry comment
The EGA welcomes the fact the EMA is revisiting the fees issue. However, Suzette Kox, the association’s senior director scientific affairs, said it would reserve judgement until it had seen the new proposal5. The EGA’s main concern is to ensure that generics companies are not supporting the pharmacovigilance system in a "disproportionate manner", as the pharmacovigilance workload for generics is low.
EFPIA, the EU R&D-based pharmaceutical industry federation, is supportive of a simplified fee structure, such as a flat maintenance fee. “We look forward to reviewing a new proposal,” director general Richard Bergström said6.
EFPIA’s biggest concern with the original proposal was the total budget, Mr Bergström commented. “The Commission impact assessment, when they presented their first proposal, suggested SAVINGS [EFPIA’s emphasis] due to streamlined reporting. However, the end result of the Council and EP [European Parliament] review looked quite different.”
References
1. Commission consults on new types of fees payable to EMA under EU pharmacovigilance law, Scrip Regulatory Affairs, 19 June 2012
2. Introduction of fees to be charged by the EMA for pharmacovigilance, Ref. Ares(2012)723154 - 18/06/2012, http://ec.europa.eu/health/files/pharmacovigilance/2012-06_concept_paper_en.pdf
3. Universal opposition to EU pharmacovigilance fee plan, Scrip Regulatory Affairs, 6 December 2012
4. Responses to the public consultation on the concept paper on the Introduction of Fees for Pharmacovigilance to be charged by the European Medicines Agency, 30 November 2012, http://ec.europa.eu/health/human-use/pharmacovigilance/developments/index_en.htm
5. Personal communication, EGA, 17 February 2013
6. Personal communication, EFPIA, 17 February 2013