Entering 2020 with a stride, Luxembourg approved a new law regarding its pharmaceutical regulation and is to create a public agency for both medical and health-related products (ALMPS). What are the lessons to be learnt from similar regulatory agencies?
As one of the few member states without a designated regulatory pharmaceutical body to date, the novel task fell to the authority of the ministry of health. With the rise in counterfeit medication ailing Europe, the Luxembourgish market is no exception to this phenomenon. The creation of a highly specialised agency is therefore much welcomed, considering the UK’s MHRA was founded two decades ago in 2003.
The ALMPS will operate under the authority of the health ministry and be involved throughout the regulatory process of drugs within the market. From pre-market entry to post it will prioritise a greater regulation of medications including cosmetic products, food supplements as well as medical devices. The public entity aims to thus tackle counterfeit drugs circulating in the market and poor-quality medication. The purpose of regrouping all health-related and medicinal products under one entity is to better standardise the Luxembourgish market. In doing so a greater effect on public health can be ensured, so as to regulate the market for “mediocre” or inefficacious medication. Thus, a smoother, safer and more effective access of high-calibre medication is guaranteed to be delivered to the general public.
What is more pertinent to citizens is the key role the ALMPS will play in the reporting and monitoring of drugs post-market entry, achieved via increased surveillance of the general public, via enhanced reporting schemes for adverse drug reactions or medical device incidents. Tying in with the latter is the assessment and authorisation of permitted medical products for sale and supply in Luxembourg. The ALMPS will be tasked with ensuring that medical device manufacturers comply with regulatory requirements before entering the market.
Further areas of jurisdiction include investigating internet sales for counterfeit medicines and ensuring prosecution, the promotion of the safe use of medication to the general public, whilst managing the research and promotion of safe clinical practice.
The long-awaited ALMPS will directly interact with the European Medicines Agency (EMA) [EC 726/2004 regulation] for authorisation and supervision of medicinal products licensed for human use. Possible future collaborations of the agency include its involvement--if any--with the Horizon Scanning Project whose role is to investigate pre-market entry of significant novel medical technology innovations. Linked to the project, alongside accruing pressures to ensure sustainable access for innovative medicine at costs affordable to the European public, we could additionally see the ALMPS enter as part of Luxembourg’s pledge to the Beneluxa initiative which emphasised the country’s role in seeking collaborations regarding pharmaceutical policy.
If any lessons are to be learnt from other established members states’ medicines regulatory agencies, maintaining transparency is a concern the ALMPS will need to address whilst ensuring it does not fall prey to regulatory capture.
Dr Lilani Abeywickrama is a Luxembourgish ophthalmologist currently based in Milan. Her main interest is advocating healthy living and precision technology within her specialty and is pursuing her interests in the field of healthcare management.