New European Focus on Medicine Supply Chains Means More Disclosure
Maurits Lugard and Anna-Shari Melin examine the new era of supply chain scrutiny and explain how the EMA’s new critical medicines lists will work.
The conflict in Ukraine has amplified the medicinal product supply chain issues which already existed due to COVID-19, and indeed prior to the pandemic. EU regulators – which face increasingly fierce political pressure to maintain a well-functioning health care system – view these supply chain issues as a serious problem which have the potential to massively, negatively impact patients. As the regulators continue to investigate the root causes of shortages, the pharma industry is experiencing a steady flow of new guidance and legislation aimed at enhancing crisis preparedness and easing shortages.
A significant, recent development in this area was the coming into force, in March, for a new legislation (EU Regulation 2022/123, ‘the Regulation’) which reinforces the role of the European Medicines Agency (EMA) in crisis preparedness and aims to provide more transparency in the supply chain. Of particular importance to pharma companies, is the fact that the Regulation gives the EMA the right to request ‘relevant information’ from companies about medicinal products that are on its critical medicines lists.
Critical medicines lists are intended to be used in circumstances where a major event or public health emergency occurs. They will cover the authorized medicinal products which require close monitoring during such a crisis because of the increased risk of shortages.
The first of these lists was published on 7 June, setting out the ‘List of critical medicines for COVID-19 public health emergency.’
By August, we expect the Medical Device Safety Service (MDSS) to also publish a list setting out the main therapeutic groups of medicinal products that are necessary for emergency care, surgery, and intensive care. This list will inform the preparation of future ‘major event critical medicines lists’ and ‘public health emergency critical medicines lists.’
The Regulation specifies that all marketing authorisation holders (MAHs) for medicinal products authorized in the EU are required, by 2 September, to establish and communicate to the EMA a named point of contact who is responsible for providing information to the EMA if their medicinal products appear on one of the critical medicines lists. This information – which is outlined in Articles 9 and 10 of the Regulation – will need to include data on the sales and market share of the MAH’s product, the available stock of the product, and a forecast of supply for the product, which includes information on potential vulnerabilities in the supply chain. The EMA has separately advised that it will advise MAHs on how and when to submit this information to the EMA, in due course.
There have been some industry concerns that, under the Regulation, pharma companies may be required to publicly disclose commercially confidential information (‘CCI’). However, the Regulation does allow the MAH to identify such CCI, and obliges the EMA not to disclose such CCI where this is judged to be justified.
Pharma companies should follow the developments in this field, expect to be contacted by the EMA to provide a single point of contact, and prepare for the event that their medicinal products may be placed on one of the critical medicines lists. For example, pharma companies should review their agreements with supply chain partners and ensure that these agreements allow for them to obtain the information the Regulation requires them to report if requested to do so.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
