A bill has recently been in discussion in the US that contains measures to strengthen the ways in which drug shortages are dealt with. The US FDA is also taking action by asking companies to alert them as to possible drug shortages so that it can prepare back ups. But what about other parts of the world?
Drug shortages are not unique to the US. The UK is also currently struggling with severe shortages of prescription medicines. In the US, many shortages have been attributed to plant closures or manufacturing problems, but in the UK the shortages are being caused for a different reason: parallel trade.
Parallel trade, which is legal in EU law, involves products intended for the UK market being exported to other EU countries where they can often be sold at higher prices. This practice is common throughout Europe and has caused drug shortages in several countries over the years, impacting both patients and pharmacists who subsequently have to spend time sourcing medicines rather than performing other clinical and public health services.
Last week, the UK’s All Party Pharmacy Group (APPG) published a report detailing the results of an inquiry into drug shortages, which have plagued the UK for four years. The inquiry investigated the causes of the shortages, the problem they have caused, the effectiveness of efforts to tackle the problem and potential solutions. Occasional supply problems caused by manufacturing issues were not a focus of the inquiry as they have already been identified and there are contingency arrangements to deal with them.
But unfortunately there is no simple solution. The UK has already tried to solve the problem by implementing quotas and other supply mechanisms, as well as issuing best practice documents, but these have proven ineffective. The UK’s Medicines and Healthcare products Regulatory Agency has also pledged to address the shortages, but a lack of market data means that it is difficult to know exactly which products are in short supply and who is exporting them.
The report also added, “We have detected an air of resignation among those responsible. The problem of shortages has been dismissed variously as either inevitable, or as having been inherited from the previous Government. The Department of Health has also seemed reluctant to take action without having hard evidence…”
One drastic suggestion in the report is to put a stop to the exports. European law allows for the free movement of goods across EU borders, but the report claims that there it is possible to exempt certain goods if their free movement threatens public health. The report urges the government to at least consider this exemption.
In addition, the report poses other recommendations including:
- The UK government must state that the interest of patients comes first ahead of the free movement of goods.
- The MHRA needs to enforce obligations on those with licenses to conduct wholesale activities.
- There needs to be improved and more regular collaboration between the Department of Health, the MHRA and supply chain representatives.
- The paucity of market information needs to be addressed urgently.
- Quota arrangements need to be simpler, less burdensome for pharmacists, more transparent and more sensitive to local variations in demand. A task force should be established to deal with this issue.
The APPG has invited the Department of Health to provide an update in six months’ time about its progress in tackling the shortages.