Safety, Quality, Efficacy: Regulating Medicines in the UK

SAFETY, QUALITY, EFFICACY: REGULATING MEDICINES IN THE UK
4.11 Industry representatives we spoke to felt there was scope
for the Agency to do more to promote the UK position
in Europe and that more resources should be devoted to
providing high-level representation on European expert
committees. They would like to see European agencies
generally taking a more integrated approach to
regulation, with different agencies concentrating on
their particular strengths, and relying more on each
other's work.
The Agency may be at risk of not
providing services that industry
within Europe requires
4.12 With an increasingly global pharmaceutical market,
most new medicines will be sold in more than one
European country. It therefore makes sense for
companies either to apply to the European Medicines
Evaluation Agency for a centralised European marketing
authorisation, or to achieve mutual recognition of a
licence obtained in one member state. Historically, the
UK has been among a handful of countries with wellestablished
and well-respected regulatory expertise. The
Medicines Control Agency has as a result received a
larger share of applications under the mutual
recognition arrangements than would be expected.
for inspection and enforcement activities. The Agency is
acutely aware that it needs to remain competitive to
retain its share of both centralised and mutual
recognition business in Europe. However, the level and
structure of fees charged by the Agency is a policy
decision for Ministers.
The Agency has worked with
potentially conflicting dual
objectives to help industry and
protect public health
4.15 Since its creation, the Agency has been required in its
Framework Document to avoid creating "unnecessary
impediments" to the pharmaceutical industry. In line
with this, the Agency has recently been closely involved
in efforts to improve the regulatory environment for
industry through the work of the Pharmaceutical
Industry Competitiveness Task Force, set up by the
Government in March 2000. This role has, however,
been articulated in the Agency's 2001 Corporate Plan in
a more active way than its original remit not to create
impediments. The remit has been re-expressed as being
"to facilitate the development of a successful UK
pharmaceutical industry for the benefit of the wider
interest of the UK economy".
4.13 In recent years, however, competition from other
European regulators has increased. The two main
reasons for this, put to us by industry in the UK and
regulators abroad, were:
! that industry is increasingly looking to consult with
regulatory agencies for advice before submitting
applications. While the Swedish Medical Products
Agency has focused on encouraging dialogue with
companies, and charges for its advice, the
Medicines Control Agency has not been able to
charge a fee for advice to industry. As a result, it has
found it difficult to devote resources to this work.
The Agency is considering what changes to its
powers may be needed to allow it to charge fees for
this work; and
! the fees charged by the Medicines Control Agency
for new active substances are the highest national
fees in Europe.
4.14 The high level of UK licence fees partly reflects the fact
that the Medicines Control Agency is financed entirely
by fee income, whilst some other regulators have partial
state funding. It also reflects the fact that UK headline
fees are designed to cover a broader range of work
throughout the life of a product than is the case in some
other countries. For example, the Netherlands
Medicines Evaluation Board Agency is not responsible
4.16 Stakeholders from the consumer and patient groups we
consulted were concerned that the relationship between
the Agency and the industry it regulates may be too
close. This perception is reinforced by the fact that the
Agency is fully funded by fees from industry, which is
not the case in some other countries (Figure 27).
27
Funding arrangements abroad differ from those of the
Agency
Regulator
Canadian Therapeutic
Products Directorate
US Center for Drug
Evaluation and Research
French Agence Française de
Sécurité Sanitaire des
Produits de Santé
Swedish Medical
Products Agency
Netherlands Medicines
Evaluation Board Agency
UK Medicines
Control Agency
Source: National Audit Office
Percentage of funding
derived from industry fees
66 per cent
52 per cent
50 per cent
95 per cent
100 per cent
100 per cent
part four
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