Unlicensed Medicines Woes in the UK
I’ve written frequently about the problem of counterfeit medicines in the United Kingdom and how the country’s Medicines and Healthcare products Regulatory Agency (MHRA) is working to prevent these, but counterfeits are not the only potentially dangerous medicines that are becoming increasingly prevalent. In a recent news release, the MHRA explained it is receiving a growing number of reports of unlicensed medicines being sold across the UK.
According to the MHRA, many of these products originate from Poland or other Eastern European countries, with the agency investigating 74 cases last year. Several of these medicines fell into the category of pharmacy- and prescription-only medicines. Although the medicines may be licensed in Poland, or other European member states, the MHRA has emphasised that such products cannot be sold or supplied in the UK.
In a statement, the MHRA added that it is working with the Polish medicines regulator to help communities where these medicines are being sold.
The big question about why unlicensed medicines are being sold in the UK can perhaps be answered by the fact that there are a growing number of Polish people now living in the UK, who may wish to have access to medicines they have used in their home country. The same can be said for people of any nationality who find that certain medicines they have taken before are not available in the UK.
Unfortunately, even if a medicine is approved in Poland it doesn’t mean it’s necessarily safe, particularly if taken without adequate supervision. Selling such medicines is also illegal, although it is possible to obtain an MHRA Parallel Import Licence or a Parallel Distribution Notification for certain medicines. Worryingly, it’s also possible that the demand for foreign medicines could lead to counterfeit products being sold in the UK by criminals seeking to take advantage of this opportunity.
“Polish medicines imported into the UK and sold in Polish language packs have not been approved for sale in the UK and cannot be traded lawfully on the UK market. Medicines offered for sale and supply in the UK must be labelled in English,” Nimo Ahmed, the acting head of enforcement at the MHRA, said in a statement. “We urge people not to buy medicines that are not labelled in English. Medicines are not ordinary consumer products. There are also specific health concerns with certain medicines that should be prescribed and dispensed under the supervision of a healthcare professional, such as a doctor or a pharmacist. Anyone who self-medicates and buys these medicines from shops that are not registered pharmacies could be endangering their health.”
With globalisation increasing and many people now choosing to emigrate, unlicensed medicines could become a greater issue for regulatory agencies and the situation will need to be closely monitored.
‘Unfortunately, even if a medicine is approved in Poland it doesn’t mean it’s necessarily safe’
As Poland is part of the EU they legally have to comply with 2003/94/EC for GMP and 2001/83/EC for marketing a medicine within the EU. Safety, quality and efficiacy are the main principles of drug approval and hence a drug would not be approved within the EU if any of these principals are not met. reversing your statement then would the Polish community consider medicines approved by the MHRA as unsafe? What if a medicine was marketed via decentralised or Mutual recognition in both UK and Poland – would the Polish approval process be inferior to UK approval process?
‘the MHRA explained it is receiving a growing number of reports of unlicensed medicines being sold across the UK’
unlicensed medicines can be sold within the UK providing this is done under MS or WL licenses for unmet clinical needs (as per Art.5 2001/83/EC). In fact the ‘growing number’ is probably due to the increase seen in commercial compounders of unlicensed products for use in the hosptial settings such as TPN and chemotherapy. Without these services patients could potentially be denied treatment for a host of illnesses. Remember there is also the Section 10 exemption to the Medicines Act 68′ which allows for pharmacists to prepared medicines without a marketing authorisation for individual patient use. Hence unlicensed medicines are the cornerstone of cancer treatment within the NHS and private hospital sector.
‘Worryingly, it’s also possible that the demand for foreign medicines could lead to counterfeit products being sold in the UK by criminals seeking to take advantage of this opportunity’
there is also a demand for UK medicines which has already led to counterfeit medicines entering the supply chain (e.g. plavix). Therefore this is not a risk solely for unlicensed medicines.