LONDON - Among the proposals in the European Medicines Agency's five-year strategy document, the "Road Map to 2015", is a call for closer ties with health technology assessment (HTA) bodies like the UK National Institute for health and Clinical Excellence (NICE).

The agency wants to discuss how HTAs can be involved earlier in the medicines development process, in order to avoid the appearance of having two parallel systems with slightly different requirements: one revolving around clinical risks and benefits, and the other around relative effectiveness and cost benefits.

EMA's Executive Director Thomas Lonngren in September 2009 flagged his concern that decision points for a drug approval and cost-effectiveness were edging toward becoming simultaneous. This, he said, caused confusion, particularly since health technology assessors increasingly are issuing their own scientific advice, which could conflict with that of the regulators ('The In Vivo Blog', Sept. 11, 2009).

"We need some agreement [with HTAs] so that industry doesn't find itself doing one development program for EMA, and another 27 for the various member-state HTAs," Lonngren said in an interview in September.

Attempting to reach some kind of consensus makes sense, not least in order to improve drug development costs and timelines. Plus, HTA agencies have, themselves, been calling for more insight into EMA's decision-making processes.

Earlier this week, EMA held the first of a series of workshops with a network of European HTA bodies, snappily named EUnetHTA, to evaluate if the EU's European Public Assessment Report (EPAR) can contribute to the HTA bodies' assessments. The EPAR outlines the conclusions of the EU's scientific evaluation body, the CHMP, and commercially sensitive information is deleted from EPARs.

Reaching any consensus will be tricky, though, given that Europe's HTA bodies are far from harmonized, remain national, and typically are highly political institutions. NICE, for example, points out there still will be differences in data requirements for approvals and appraisals, even if a "more joined up approach" is taken by the two types of authorities. But it is not against the proposals - it says it already has held exploratory talks on the issue with both the EMA and the U.K. regulator, the MHRA.

A Global Drug Regulator?

Besides proposals to improve the quality of its core business - the evaluation and supervision of medicines for the benefit of public health - the EMA is also calling for more collaborations with other regulatory authorities around the world.

Global regulatory harmonization is hardly a new concept, but remains something of a pipedream given widely different national health care systems and often highly politicized national agendas. EMA alludes to the possibility of a worldwide approval from a single agency but meantime it is proposing an international strategy that "creates synergies through collaboration, co-operation and communication with regulatory partners, with a view towards supporting in the long term a global approach to the authorization and supervision of medicine."

Those are good words. There already are bilateral agreements between regulatory authorities on exchanging information and on collaborating across a range of areas, including inspections and pre- and post-approval processes. The most recent is between EMA and the Swiss regulator, Swissmedic, to exchange confidential information about the authorization and safety of H1N1 pandemic influenza medicines.

Such agreements hardly amount to trans-national approvals, though. And certainly confidentiality agreements between the U.S FDA and EMA haven't stopped EMA taking different decisions on product approvals to its counterpart across the Atlantic Also see "Weighing Obesity Risk: FDA, EMEA Use Different Scales For Abbott's Meridia" - Pink Sheet, 21 January, 2010.).

Improving Access And Safety

EMA's Road Map highlights a growing role for the agency in addressing public health needs, as well as in facilitating access to medicines and optimizing the safe use of medicines. Public health needs are in tune with the interests of John Dalli, the new EU health and consumer policy commissioner, who now oversees EMA. This power was, somewhat controversially, transferred from the European Commission's Enterprise and Industry directorate to the Health directorate at the end of 2009 ('The Pink Sheet', Dec. 14, 2009).

New EU legislation is being drawn up to tackle counterfeit drugs and to improve EU-wide pharmacovigilance, and necessarily will involve EMA. This legislation is two-thirds of the so-called pharmaceutical package; Dalli already has said he will remove the controversial third component - European-wide rules on what kinds of information drug companies can provide to patients - so that it can be debated in greater depth (Also see "EU Tackles Counterfeits, But Parallel Trade Poses Tough Issues" - Pink Sheet, 5 January, 2009.).

EMA says it intends to take a more proactive approach to ensuring patient safety, including tapping new data sources, building its capacity to monitor post-authorization safety, and obtaining more information in "real life" situations, including the use of post-authorization development plans and conditional approvals. So far, there have been only a handful of conditional approvals for products including GlaxoSmithKline's breast cancer therapy Tykerb (lapatanib) and, more recently, for Gilead's antibacterial nebulizer, Cayston (aztreonam).

EMA also would like to become the authoritative source of information for all medicines it evaluates and for syndication to regulatory authorities throughout the EU. The agency argues it would concentrate on the quality and consistency of the information, while others would focus on how information is communicated to patients and healthcare professionals. EMA believes it could plan this even while the political debate on the patient information provisions of the pharmaceutical package continue.

Productivity Gap Addressed

It may be heartening for the pharmaceutical industry to know that EMA is going to help it confront the productivity gap in R&D with another of its priorities - facilitating access to medicines.

Companies are dissatisfied that scientific advice given early in a product's development can be overtaken by medical and scientific changes later on, and that complying with the earlier advice does not necessarily lead to a marketing authorization. The EMA says it will aim to improve the scientific advice process, so that by adhering to it a company improves the chance of having its marketing application approved. But there are no further details on how it will do this.

EMA also would explore what incentives could be offered to companies to allow data in failed medicine developments to be made available to the scientific community. Such data could help avoid repetitive or redundant animal or clinical studies, it believes.

Antibiotics may be old-school, but the EMA lists the limited availability of novel antibiotics as one of its critical areas of concern in public health. It proposes to launch initiatives such as rapid assessment programs of potential new antibiotics to remedy the situation, and notes that such schemes also would be used to address the need for drugs for rare and neglected diseases.

Over the next three months, EMA is inviting industry and other interested parties to submit comments on its road map, which it will take into account in revisions to the plan.

- John Davis (j.davis@elsevier.com)

EU Regulator Wants Closer Ties With Health Technology Assessors

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