Date Published: 8 August 2006
UK plans to reduce admin of regulation of over the counter (OTC) medicines
Government commitment to cutting red tape continues:
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 administrative processes.
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.
Source: UK Dept. Health