One policy change that could help Europe fight medicine shortages would be for the EU to give more regulatory flexibility to parallel importers, especially in relation to language requirements.
It’s undeniable that medicine shortages are occurring with frequency around Europe. But it does not have to be this way. From adjustments in EU policy and clearer requirements for manufacturers, to better facilitation of imports and exports in the internal market, this is a problem that can be solved.
Here are some of the most common reasons why medicine shortages take place and what policy changes could alleviate them.
Problem #1—manufacturing issues
Manufacturing and quality issues such as the temporary closure of a factory or production lag times are among the main root causes of shortages in Europe. How do we address this problem? Here are three actions that could be taken:
- Whenever a marketing authorisation holder reports a shortage, it should be obliged by EU law to make a prevention and or response plan.
- An EU-wide legal obligation should exist that requires marketing authorisation holders to maintain a safety stock of 2-4 months for medicines of major therapeutic interest.
- EU legislation should provide for the possibility to impose financial sanctions if the responsibilities related to shortages plans and stockpiling are not met.
Problem #2—supply issues
Problems in the supply chain of medicine, such as supply quotas, inefficiency in logistics, and relying on too few suppliers, contribute to medicine shortages. Here are five recommendations that could help mitigate the problem:
- Requirements for having diversified supply sources could be incorporated in the requirements when the public sector buys medicine.
- Wholesalers should have a right to be supplied by manufacturers in order to meet patient needs and ensure sufficient buffer stocks and a competitive internal market.
- Supply quotas must always be sufficiently transparent, flexible, and justified, and ‘black-box’ quotas should be banned.
- Member States should set up NCA-led national dialogue platforms between supply chain stakeholders to exchange information on products in shortage or in risk of shortage.
- Patient and healthcare provider platforms should be created to directly assist patients and healthcare providers with their needs.
Problem #3—regulatory issues
Regulatory problems, such as lag time on approvals, national requirements, and the lack of harmonisation, also lead to medicine shortages. Here are two changes that could help mitigate the problem:
- In the context of shortages, the EU should give more regulatory flexibility to parallel importers, especially in relation to language requirements.
- Packaging requirements of medicines should be harmonised at an EU level.