Last week, DRA Consulting held an open discussion meeting for experts around the theme “Managing availability of medicines – experiences, means and tools”. The event brought together more than 50 representatives of the pharma industry and medicinal wholesalers. The Swedish and Norwegian authorities also participated via video presentations.
During the afternoon, the participants tackled concrete questions such as the following:
• How do drug regulatory authorities around Europe collect and publish information about shortages?
• What can pharma companies do in practice to prevent impending shortages? How are shortages dealt with in different countries across the Nordic region?
• How common are shortages in Finland and what are their causes? Have shortages increased recently? How big a problem do they pose from the perspective of various actors? How is the collaboration with authorities? Is there room for improvement?
Shortages are sometimes due to factors which are beyond the control of Finnish players
Sanna Lauslahti, Managing Director of Pharma Industry Finland who spoke at the event emphasised that in general, availability of medicines in Finland is very good. Many things are also beyond the control of Finnish players, because
• Shortages may be due to a sudden, unanticipated increase in the global demand for a given medicine;
• Finland is a small area both linguistically and as a medicines market; thus, it is not easy to respond to fluctuations in demand;
• Finland is highly dependent on goods transported from abroad, and transportation disruptions lead to availability problems;
• In Finland, wholesale prices of medicines are low compared with many other European countries; As the manufacturing capacity is limited, medicines may be allocated primarily to more profitable markets.
There are specific challenges associated with hospital-only products, such as tight delivery schedules for the first batches after conclusion of agreement and the financial burden of sanctions triggered by shortages. For this reason, pharmaceutical companies do not always participate in hospital tenders.
Results of a EU-wide survey: How are shortages managed in Europe?
This spring, DRA invited the members of the EuDRAcon network to participate in a survey on the practices of monitoring the availability of medicines in the various member states. The results show that in almost all European countries, industry players are required to report shortages to authorities. In many countries, the reason for the shortage must also be stated. Except in Poland, the Czech Republic, Luxembourg, Slovenia and Bulgaria, all national authorities publish shortage information on their websites, i.e., it is publicly available.
Improved communication is needed – who would start the ball rolling?
There are considerable differences in the format of published shortage information and the accessibility of such information even between the Nordic countries. The Swedish and Norwegian authorities maintain separate summary tables which are based on notifications submitted by companies and contain information about the causes and durations of shortages, etc., including the authority’s advice for shortage situations. The Swedish and Norwegian authorities also publish separate news releases on shortages. In Finland, the Finnish Medicines Agency Fimea publishes individual shortage notifications as submitted on its website.
Participants in discussions agreed that in Finland, the manner in which information is published and communicated to relevant recipients, especially prescribers, could be improved. Regardless of shortage notifications submitted to Fimea and company announcements, information does not reach prescribers.
The DRA expert event marked the launch of DRA’s new event concept which offers pharma industry players a joint forum for exchanging thoughts on topical issues. DRA’s experts invite representatives of the pharma industry and authorities to take part in constructive dialogue and give presentations introducing the themes. The next event will be held in the autumn.