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EMA proposes new fee structure for pharmacovigilance

On 18th June 2012, a concept paper on the introduction of fees charged by the EMA for pharmacovigilance was published by the EU Commission. Consultation for the concept paper ended on 15th September, 2012, which resulted in 85 replies (66 from industry, 12 from national regulators, 4 from civil societies and 3 from individuals). The vast majority of responders did not support the new proposals for fees; in particular, the amounts being charged were questioned.

At present national regulators charge separate fees for pharmacovigilance activities. The argument put forward by industry was that one of the primary objectives of the new EU pharmacovigilance legislation rolled out in June 2012 was to reduce the administrative burden and minimize associated pharmacovigilance costs for the pharmaceutical industry. Members of the pharmaceutical industry have estimated that the proposal for a complete overhaul of the fee structure would result in an increase of more than 50%, in some cases the increase in fees may even double current budgetary figures.

The potential impact on SMEs with large numbers of product licences, trading in generic markets with well-established products would be severe. All SMEs expressed concern that the new fee structure would place a heavy burden on this portion of the industry, putting many products under threat of withdrawal.

So, what do the EMA want to charge for? The proposal has outlined a number of ways the EMA would recoup running costs:

1. Fees for the assessment of Periodic Safety Update Reports (PSUR)
2. Fees for the assessment of Post Authorisation Safety Studies (PASS)
3. Grouping fees for PSURs, PASS and Pharmacovigilance Referrals
4. Fee for pharmacovigilance referrals
5. Fee for pharmacovigilance services, which would include costs of ICT tools and services and literature monitoring

There have been calls for more transparency on how the EMA and national regulators distribute these fees to ensure companies are not charged twice for the same assessment or procedure. Questions were raised regarding charges for signal detection and literature monitoring, since the burden of these activities still lies with the marketing authorisation holder (MAH).

There is some light at the end of the tunnel, with proposals for fee incentives for SMEs and a full exemption for micro-enterprises. There are ongoing discussions regarding the methods used to determine how the fee incentive should be structured, such as charging companies based on annual turnover (similar to the current MedDRA subscription arrangements) or distinguishing between medium sized SMEs and small SMEs, thereby providing a 50% or 75% fee reduction respectively. Proposals have included reducing fees for orphan drugs and other low volume/low sales products to prevent market withdrawal.

The overall message from industry was clear. Companies expect fair treatment and whilst industry agrees that the 2008 fee structure is outdated, the expectation is that any fee increase should be proportionate to size of the company and specific to type of product. There was a call for an independent body to provide arbitration where fees are disputed.

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