Drug shortages across Europe are not commonplace, but when they occur, they can have a severely negative impact on patient health, specifically where no alternative therapies are available.
Speaking at the 27 annual DIA EuroMeeting in Paris, France, Pär Tellner, EFPIA Director of Regulatory affairs, acknowledged industry’s obligation to supply and emphasized that medicines manufacturers were working hard to understand why shortages occur.
“The pharmaceutical industry in Europe is fully aligned with regulators´ objective to serve patients with quality medicines and is committed to minimize current medicines shortage. EFPIA is actively engaged with stakeholders to build a preventative approach to medicines shortage,” he said.
The problem is, though, that a silver bullet for the issue simply does not exist, in part because the causes behind shortages are often diverse. They include, for example, the devaluation of exchange rates – which can encourage excessive parallel trade to the detriment of the domestic market.
From an industry perspective, the implementation of drastic health care cost containment measures disproportionately impacts pharmaceuticals and, as such, may have a knock-on effect on wholesalers and pharmacies.
Then there is the problematic issue of international reference pricing, which often results in a race to the bottom and disincentivises medicines manufacturers.
The point is that where incentives are removed and rewards for innovation are slashed, manufacturers may move out of these therapeutic areas, thereby leaving gaps in the market and causing access issues in some countries.
So shortages and access are inextricably linked. EFPIA firmly believes that proper enforcement of existing regulatory obligations will improve the integrity and transparency of the supply chain and work towards preventing drug shortages. “Regulatory enforcement, together with an improved understanding and better management of the supply chain would go a long way to improving access to medicines,” Tellner explained.
Of course, there are a number of building blocks needed to ensure that this works. There needs, for example, to be better reporting of shortages in the EU member states and greater transparency across the supply chain.
What is likely to go some way towards alleviating the shortage problem is the EFPIA-basked European medicines verification system, which aims to secure the legitimate pharmaceutical supply chain. With verification at each stage of the supply chain we will be able to ensure that medicines are received from and supplied by duly authorised players who fulfil their respective regulatory obligations.
Ultimately, though, what is required is a collaborative approach by healthcare stakeholders towards solving the shortages issue. This is in fact happening.
Regular meetings have been staged between EFPIA, the Association of the European Self-Medication Industry (AESGP), the European Association of Euro-Pharmaceutical Companies (EAEPC), the European Association of Hospital Pharmacists (EAHP), the European Generic medicines Association (EGA), the European Association of Pharmaceutical Full-Line Wholesalers (GIRP) and the Pharmaceutical Group of the Euopean Union (PGEU) to identify common ground for action.
Rather than playing a simply blame game, the idea has been to explore areas of common ground in which European cooperation may bring benefits, in terms of easing the problem, or improving communication between stakeholders. In essence, we aim to ensure that drug shortages are tackled across the supply chain via means of a partnership approach that operates within the remit of existing legislation so as to better ensure security of supply for patients.1