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Tuesday, September 1, 2005
A broad welcome to the Government’s response to the House of Commons
Health Select Committee’s recommendations following its inquiry
into the influence of the pharmaceutical industry has been given
by the Association of the British Pharmaceutical Industry (ABPI).
In
particular, the industry endorses the emphasis given to patient
safety in both the select committee’s recommendations and the Government’s
response.
“The safety of medicines is of paramount concern to the pharmaceutical
industry, and we welcome the recognition that this is given,” said
Dr Richard Barker, Director General of the ABPI. “It is important
that clinical trials are well designed, that their results are
transparent and the benefit/risk of new medicines is rigorously
monitored once they are in regular use.
“It is also appropriate that the Government’s response – like the Select Committee’s
report – recognises the importance of the pharmaceutical sector to the UK,
with particular regard to what it rightly calls the industry’s ‘outstanding
record of innovation for the benefit of patients’ as well as its contribution
to the economy.”
Concern over patient safety led the Select Committee to make various
recommendations on the current ‘Yellow Card’ system of reporting
adverse drug reactions. These recommendations are accepted by the
Government, and the ABPI also endorses them. The Yellow Card system
is an essential mechanism for reporting side effects of new medicines,
but can only operate effectively if broad and full use is made
of it.
The Government’s plan to investigate medication errors, what is causing them
and how to reduce them is also warmly welcomed. There are many possible
causes of such errors, including systems deficiencies and incomplete staff training
for hospital pharmacists and medical staff. Specific research to examine
the causes of such errors will enable the NHS and the industry to take appropriate
action.
On the marketing side, the Government states its intention that
promotional material for new products should be pre-vetted by the Medicines
and Healthcare products Regulatory Agency (MHRA). The ABPI notes
that the MHRA already has powers to carry out such pre-vetting.
However, it is important that this action does not further delay
innovative, new medicines from reaching patients. The Government
must ensure that the MHRA has the appropriate staff with the right
levels of expertise to carry out such pre-vetting without delaying
the medicine’s availability.
On the rare occasions when companies are found to have breached
advertising regulations, or published misleading findings from
research, the Government appears to be considering whether and
in what way the allowances for promotion and research, respectively,
should be reduced under the Pharmaceutical Price Regulation Scheme
(PPRS). The ABPI will discuss this with Government at the appropriate
time. However, it is important to remember that the PPRS is designed
as a mechanism for regulating company profitability, not for
controlling marketing standards.
The ABPI believes the Government has underestimated the situation
with regard to relevant areas of the science base. There is a danger
of insufficient properly trained scientists in the right disciplines,
especially chemistry, coming through the UK university system,
and the industry is increasingly having to recruit from abroad.
Further action in this area would be welcomed.
The Government has recognised the concerns that lay behind the
Select Committee’s
recommendations on patient groups and how they receive and acknowledge
funding from other sources, including the pharmaceutical industry, and
emphasised the importance of self-regulation. The ABPI endorses both these
points.
There is a broad movement towards greater transparency in all
aspects of the industry’s affairs, which is supported by the ABPI. The need
for greater transparency over the publication of clinical trial
results was also recognised in the Government’s
response.
At the beginning of the year, the worldwide industry announced
the establishment of registers of clinical trials that are underway
and results of trials that have taken place, whether positive or
negative. The Government’s
response welcomes the global pharmaceutical industry’s initiative
in establishing these voluntary registers. The industry’s commitment
has since been underlined by creating a portal via which all
such information can be accessed, in advance of that eventually
to be established by the World Health Organisation.
“The welfare of patients has to be at the centre of actions of
both Government and industry with regard to the Select Committee’s
recommendations,” said
Dr Barker. “We recognise that action has to be taken in some
areas and endorse the majority of the Government’s proposals,
but it is essential that they are implemented in such a way that
they do not delay – or,
worse still, deny – patients’ access
to the benefits of modern, innovative medicines.” |
