(2) if she will plan an urgent review of UK preparedness to deal with the risk to patient safety of counterfeit medicines;
(3) whether new measures are being considered to stop counterfeit medicines reaching patients;
(4) what resources she plans to dedicate to tackling the risks posed by the supply of counterfeit medicines in the next three years;
(5) what her assessment is of the scale of the risk in Europe from the supply of counterfeit medicines;
(6) if she will make a statement on the four recent class 1 recalls of counterfeit medicines found in the UK legitimate supply chain;
(7) what assessment she has made of a possible link between suppliers of counterfeit medicines and organised crime;
(8) what resources she plans to commit to tackling the illegal trade in counterfeit medicines in the next three years.
The Medicines and Healthcare products Regulatory Agency (MHRA) is currently conducting an investigation into the circumstances surrounding the recent penetration of counterfeit Casodex, Zyprexa and Plavix into the regulated supply chain which led to the class 1 recalls. The number of patients affected will not be known until the completion of the recall and the investigation.
A class 1 recall, a system to recall medicines with immediate effect, was undertaken because initial analysis has shown a reduced amount of the correct active ingredient present in each of the counterfeit products. Counterfeit products commonly contain reduced quantities of active pharmaceutical ingredients. These are unlikely to have been manufactured to good manufacturing standards and may contain impurities which put health at risk. The class 1 recalls were considered necessary as evidence suggested these products may have reached pharmacy and patient level.
The extent of counterfeit medicine in circulation worldwide is difficult to estimate. The World Health Organisation (WHO) has published estimates suggesting up to 10 per cent. of medicines globally are counterfeit. This is more prevalent in developing countries and less so in developed nations. Within developed nations WHO estimate that up to 1 per cent. of medicines may be counterfeit. The European Commission has recognised that counterfeiting is a growing problem within the European Union and has undertaken a study to identify any legislative and regulatory weaknesses with a view to exploring policy options. As with all other member states, the United Kingdom has provided information on local experiences, statistics and strategies associated with combating counterfeiting.
The MHRA is developing a strategy which will address the risks to patient safety from counterfeit medicines by providing a comprehensive approach through the implementation of strategic and operational measures to minimise the risk of counterfeit medicines reaching patients through both the regulated and unregulated supply chains. This strategy is being reviewed to take into account the recent incidents and subsequent intelligence gathered from industry and our international counterparts. Resource issues are part of this strategy. The strategy will be published later this year.
MHRA works closely with law enforcement and other regulatory bodies both nationally and internationally. MHRA hosts regular meetings with stakeholders within industry, law enforcement and regulatory bodies, intelligence concerning counterfeit medicines is reviewed and assessed.
Strong links exist between the MHRA and other law enforcement agencies. MHRA works closely with the Serious and Organised Crime Agency to establish links between organised crime and counterfeit medicines.