Regulatory Focus™ > News Articles > Rising UK Drug Shortages Highlight MHRA's Oversight Problems

Rising UK Drug Shortages Highlight MHRA's Oversight Problems

Posted 15 May 2012 | By Alexander Gaffney, RAC 

The UK is facing increasing shortages of vital medicines as supplies are exported to other countries in the EU in a case of medicinal pricing arbitrage, reports Reuters.

Other countries in the EU are willing to purchase the drug for more than UK purchasing groups are, which is causing parallel trade to occur and drug shortages to emerge.

While the case is hardly unique to Britain-Greece is also suffering the effects of parallel trade after austerity measures slashes reimbursement amounts-the situation is in stark contrast to only a few years ago when Britain largely imported pharmaceutical products.

"In the case of Britain, exports have been encouraged by a weak pound, making the country a cheap place for middlemen to source supplies-in contrast to a few years ago when prices were relatively high and drugs were imported," writes Reuters.

As in the US, the medicinal shortages are causing havoc for patients who are sometimes unable to get life-saving medications for chronic conditions including epilepsy, schizophrenia and diabetes.

The shortages are also leading to calls for the UK's medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) to "do more to address supply problems and consider limiting the growth in drug wholesaler licenses," explains Reuters. The licensees, including roughly 1,800 wholesalers, are blamed for engaging in small-scale parallel trade.

An earlier Reuters report in April 2012 noted MHRA has had considerable difficulties overseeing the wholesalers, the amount of which is second in Europe only to Germany, which has more than 3,000.

"We are concerned that the MHRA doesn't have sufficient resources to inspect all the premises that have a wholesale dealer license," Malcolm West, a supply chain expert at the Association of the British Pharmaceutical Industry, told Reuters in April.

At the time, the primary concern was counterfeit copies of the Roche drug Avastin (bevacizumab), supplies of which had passed through UK-based wholesalers. Despite their small size, the volume of pharmaceuticals passing through wholesalers engaging in parallel trade is reportedly making it difficult for MHRA to exercise oversight over the sector.

Now some members of the British Parliament are demanding changes, including banning the practice of parallel import, limiting the number of licenses available to wholesalers, the expansion of quotas and demanding more information from pharmaceutical manufacturers, reports The Guardian.

Of particular concern: MHRA reportedly "does not even know which products are in shortage, much less by whom they are being exported," said a parliamentary group investigating the shortages.

Read more:

Reuters - UK lawmakers urge action on medicine shortages

The Guardian - Exporting medicines for profit puts British patients at risk, say MPs

Regulatory Focus - Report: Second Instance of Fake Avastin Highlights MHRA Troubles

Regulatory Focus newsletters

All the biggest regulatory news and happenings.