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No shortage of views being expressed on drug shortages.
Anyone who is exhausted by hearing about the upcoming revision of European Union pharmaceutical rules can ignore this article—but at a cost. One of the heads of the hydra-like rewrite of this wide-ranging legislation, now scheduled to start discussion in early 2023, will cover shortages. Not the sexiest of topics, but one with numerous implications for pharmaceutical executives everywhere, and—as is becoming apparent to all those British commentators who five years ago lightly dismissed the implications of leaving the EU—some realities ignored are still going to come back and bite.
Within the European healthcare community, there is no shortage of opinions on shortages. Patient and consumer organizations in Europe were already complaining about supply problems before the COVID-19 pandemic intensified the challenges, and they do not consider the recent remedial strengthening of the European Medicines Agency will be sufficient to fill the gaps. Among their favored remedies are tighter obligations on drug firms to launch their products everywhere in Europe and to keep them on the market under pain of tough penalties. Europe’s doctors want to see obligations on companies to stockpile safety supplies of medicines. The European Parliament contains plenty of advocates of the imposition of mandatory quotas on manufacturers, and even the creation of state-run drug manufacturers charged with ensuring continuous supply of critical medicines in rivalry to the private sector. And national drug authorities are keen to obtain much more data on upcoming supply risks much earlier. While nobody is pretending the answer is simple, there are plenty of recommendations being made that look simple, and many that, therefore, present real threats to the management of private sector pharma companies.
Faced with the prospect of some disruptive and interventionist regulation, the research-based drug industry in Europe came out in November with a series of recommendations on how they see the future—and it has, in the process, adroitly argued to advance its own interests across a range of related issues that the EU drug laws rewrite will also be tackling. Needless to say, it gives its backing—in very general terms—to the concept of greater EU involvement. But on specifics, it aims to lay down some of its own red lines about what form the solutions should take.
It emphasizes that the root causes of shortages varies from case to case and arise from many different factors that make a one-size-fits-all approach unworkable. This is a point that has been recognized already by the European Commission but not necessarily by all the other stakeholders—who are jockeying to influence the shape of the new rules. To protect itself against blanket legislation, the industry is arguing for a risk-based approach focusing on critical medicines, hinting that well-intentioned overregulation could make the problem worse.
The industry also concedes the need for better information on product availability—exploiting in the process a potential opportunity to strike a blow against the parallel importing it has for years opposed. It is arguing that the computerized system it created to tackle drug counterfeiting in Europe should be deployed as a source of data to combat shortages, too. This is a move that has long been contested by wholesalers and pharmacists, not least (though not publicly) on the grounds that the increased transparency could limit their ability to practice parallel trade.
Industry fire is also turned on the suggestions floating around that government should interfere in companies’ supply chains. Europe’s industry can, it insists, “rely on the strong EU manufacturing and R&D footprint, as well as open trade with reliable partners.” There should be no obligations on dual sourcing nor mandatory safety stocks, and the forced repatriation of the manufacture of active ingredients or of finished products “is neither feasible nor beneficial to the EU.”
The debate is also offering industry the chance to push its case for electronic patient data to take the place of package inserts. On the grounds that patient information online is more flexible—in terms of updating and of language—it has been aiming to overcome more conservative views of the importance of patients holding a piece of paper in their own language when they take a drug. Easing shortages can be assisted if stock can be moved quickly and easily across the 20-plus national languages across the EU’s member states, industry points out. Make a start, it is urging, with hospital products—seeing a possibility to get a foot inside a resistant door.
None of this is going to be decided in the near future. The importance right now is in getting a proposal that is workable.
Reflector is Pharmaceutical Executive’s correspondent in Brussels.