Drug shortages in Europe are hitting all-time highs — and countries are looking to Brussels for an answer.
In July alone, cancer patients were unable to access treatment in Italy, shortages of neurological drugs reached an “unprecedented scale” in Poland and the total number of unavailable drugs in Belgium reached a new record.
Pharmacists and health campaign groups have been warning for years of worsening shortages, partly linked to increased dependency on a limited number of suppliers located overseas.
“Whats new is that it used to be smaller countries with less attractive markets like Romania, Bulgaria, Eastern European countries,” said Charlotte Roffiaen, the councillor for European affairs at patient organization France Assos Santé. “Now its all countries — even the wealthiest ones.”
France this week became the latest country to call for an EU-wide solution. The number of drugs reported as scarce in the country increased 20-fold between 2008 and 2018, according to the countrys drugs regulator — and is predicted to rise by a further 60 percent this year.
“It is true that medicines and the required raw materials are increasingly being produced outside of Europe” — Bruno Bruins, the Netherlands medical care minister
One idea put forward by Paris in a new action plan Monday is that the EU could set up public drug manufacturers to produce some medicines to supply all countries.
With more than 30 patient and health groups asking the European Commission to investigate why Europe is experiencing increasing shortages, the Netherlands Medical Care Minister Bruno Bruins has saidthe institution must put the issue high on its agenda for the next mandate.
The head of the Commissions health department Anne Bucher said in a recent interviewthat the Commission doesnt have any plans to take further action to address drug shortages besides whats already being done, although she acknowledged the problem.
However, Health Commissioner Vytenis Andriukaitis last month told drugmakers that failure to guarantee continuous supply across the EU “will lead to solutions and ways to address this issue, which might not be of industry liking.”
One explanation for Europes rising shortages is that drugs and their ingredients are increasingly manufactured by only a handful of companies, mostly located in Asia.
“It is true that medicines and the required raw materials are increasingly being produced outside of Europe. This mainly concerns countries such as China and India,” Bruins told Dutch television two weeks ago.“If we are dependent on a limited number of countries for the production of raw materials, this makes the chain of drug production vulnerable. I find that undesirable.”
The result is that any disruption to the supply chain causes serious shortages. “For years, weve been ringing alarm bells because the market is becoming concentrated,” said Adrian van den Hoven, the director general of Medicines for Europe, which represents generic drugmakers.
He gave the example of an explosion in a Chinese factory that made piperacillin-tazobactam, an antibiotic ingredient, in 2017. The explosion left only one other manufacturer of the ingredient worldwide.
Pharmacists have also said Brexit is already causing drug shortages in the U.K., as the industry seeks to stockpile supplies just as manufacturers confidence in the countrys market wanes.
“The causes of shortages are understood to be multifactorial, including problems in production, global consolidation of manufacturing, unintended impacts of pricing and tendering policies, as well as problems within the supply chain,” branded drugmaker lobby EFPIA said in an emailed statement.
99 problems, 99 solutions
The multiple causes of drug shortages means there are many ideas for how to solve them.
Pharmacists want to be able to modify a patients prescription without having to send people back to the doctors office for a new script. Access campaigners want better transparency of drug prices to lower costs, and patients groups want national authorities to fine pharma companies more if they are responsible for a shortage.
“We [were] expecting the [ministry of health] to take measures to address the roots of the problems, not to monitor the problems” — Pauline Londeix, Observatoire Transparence Médicaments
One tactic EU countries including Belgium, Poland and Slovakia have tried to address shortages is limiting parallel trade, through which traders sell drugs purchased in one country in another, for a higher price.
“Its one of the instruments wRead More – Source