On other specific measures for dealing with medicine shortages, EMA has been trying to thrash out a consensus among a broad
range of stakeholders. On June 5, the agency held a meeting with representatives of healthcare professionals and patients
on what should be the priorities. Sharp divisions on what needs to be done have been already evident within many of the EU's
28 member states on aspects like categorizing essential medicines and what should be the responsibilities of manufacturers
and wholesalers in providing information on medicines availability. These differences are now beginning to appear at the EU
level, particularly on issues such as what are essential medicines.
In Germany, doctors' organizations have been urging the use of the category of "short-term indispensible" medicines for which
there is no equivalent alternative. "We are not supporting the concepts of 'essential' or 'short-term indispensible' medicines
being implemented on a national or on an EU level," says Dr Siegfried Throm, R&D and innovation director at the German Association
of Research-based Pharmaceutical Companies (VfA). The concept cannot be applied to many patients with illnesses that cannot
be treated "by a limited set of drugs," Throm stated to PharmTech.
Germany is among the several EU countries that have national working groups of representatives of industry, wholesalers, pharmacists,
and other supply-chain players who share voluntary information on shortages. In some states, healthcare professionals are
suggesting that the provision of information should be made mandatory. Under EU legislation, manufacturers have to provide
information on plant closures and temporary shutdowns as part of their legal responsibility to ensure adequate supplies of
certain pharmaceuticals. Some stakeholders, however, want a requirement for a broader range of information, which might be
extended to information on difficulties with raw-material supplies.
"There is an overall lack of information for supply-chain actors about the causes and possible duration of shortages," says
John Chave, PGEU secretary general. "It is time for manufacturers, wholesalers, and pharmacists to get together with the regulators
in Europe and at the very least try to improve the flow of information," Chave told PharmTech.
Some manufacturer groups are emphasizing that the main reasons for shortages are not so much because of manufacturing failures
but due to inadequacies in the supply chain, especially at the wholesaling and retailing stages. They point to the variety
of reimbursement systems among EU states that has led to big differences in medicine prices between countries. These disparities
are heightened by fluctuations in exchange rates between the eurozone of 17 countries and other EU states with their own currencies,
such as the pound in the UK, which is one of the few large EU pharmaceutical markets outside the euro area.
These gaps between national prices has triggered a considerable amount of parallel trading in medicines with products manufactured
to serve the needs of a country with low prices being diverted by wholesalers, many of them pharmacists with small short-line
wholesaling businesses, to EU countries with higher prices. In the UK, an EU country with a high level of parallel trading,
an estimated 10–15% of the country's 12,500 community pharmacists are using wholesale dealer licences (WDL) to export medicines
to other EU states.
"Parallel trading by pharmacists with wholesale dealer licences is the main cause of current shortages of branded medicines
in the UK, not manufacturing problems," explains Sam Ogden, a supply-chain specialist at the Association of the British Pharmaceutical
Industry (ABPI), London, to PharmTech.
"UK medicine prices are, at the moment, among the lowest in Europe so there is a big incentive for pharmacist wholesalers
to divert medicines supplied to them for dispensing purposes to other European countries with higher prices."
Parallel trading is legal in the EU because the right to benefit from the free movement of goods underpins the Union's single
internal market. As a result of it, the ABPI claims that manufacturers oversupply the UK market with their branded medicines
by an average of 120–130%. Ironically, this excess supports the case put forward by the parallel traders that their activities
are helping channel surplus supplies to countries with scarcities of medicines. Disagreement between different groups about
issues like parallel trading merely highlights the complexities of sorting out the EU's problems with medicine shortages.
Sean Milmo is a freelance writer based in Essex, UK, email@example.com