Government commitment to cutting red tape
Health Minister Lord Warner today announced a new programme of work
to reduce the amount of administration involved in the regulation
of over the counter (OTC) medicines, reducing the burden on industry
and allowing regulators to focus on medicine safety.
The rules governing minor changes to labeling and patient information
leaflets can cost individual companies thousands of pounds and these
costs are often passed on to the consumer through pricing of OTC medicines.
Through the Better Regulation of Over the Counter Medicines Initiative
(BROMI), measures have already been put in place to allow simple changes
to medicines labels and patient information leaflets without time consuming
administrative assessment. These measures could allow OTC medicines
to be maintained at competitive prices and enable industry to invest
some savings in continued innovation.
Lord Warner said
" OTC medicines are crucial to patient care. Over 860 million
packs are purchased every year allowing people to treat common illnesses
such as hay fever without having to visit a GP.
_ Simpler regulation can improve
public health. It enables regulators to focus their time on medicine
safety rather than carrying out lengthy
_ BROMI is one example of a key simplification
measure the Department is taking forward as part of a programme to
reduce administrative burdens."
Building on this work, other areas ripe for simplification, including
certain manufacturing changes, are in line for attention.
Each of these changes will include appropriate safeguards making sure
that public safety is not compromised. New ways of regulating OTC medicines
can be introduced as these types of medicine contain well-established
ingredients whose risks and benefits are recognised.
John Harold, President of the Proprietary Association of Great Britain
(PAGB) welcomed the new programme.
" OTC ingredients are well established with well known safety
profiles. These measures will enable better planning and earlier availability
of medicines for consumers when they need them. The new initiatives
will cut costs, improve patient information and public health by freeing
regulators to focus their time on the newer more complex medicines
where the risks associated with their use are less well known."
As well as the new scheme for labelling and patient information leaflets,
statutory warnings will be reviewed with the aim of replacing them
with information that is clear and in plain English and a code of practice
for pack design is in development.