The local National Health System (NHS) has been importing medicines from the UK for the past years. Data for 2017 shows that 85% of the medicinal products procured by the NHS in Malta were either licensed in the UK or supplied by UK companies. Following action by the Central Procurement Supplies Unit (CPSU) within the Ministry for Health in collaborative support model with the industry, the dependence on UK sourcing of medicinal products was reduced to circa 65%. This corrective action was taken to reduce Malta's exposure to potential disruptions that are being anticipated within a Brexit scenario. 

The main reason for such dependence on the UK market emanates from regulatory constraints, with particular reference to those pertaining to the use of the official language in packaging and labelling of the medicinal products marketed in each Member State. The distortions on the existing supply chains caused by changes to the UK regulatory framework as a result of Brexit, shall have a very material negative impact on the quality of care.

A comprehensive exercise was undertaken by the CPSU, to identify the medicinal products that are currently supplied or licensed through the UK to the local NHS. The exercise proposed solutions to neutralise or minimise the impact of Brexit on the supply of specific medicinal products. From this exercise, it transpired that, to date, there are currently a number medicinal products that are procured from UK economic operators and/or have a UK license.  The sourcing of each medicinal product was evaluated against the backdrop of changes to the regulatory regime and other market distortions that may follow Brexit. This is the basis of the contingency plan.

1. A local stockpiling activity has been undertaken and is ongoing by the CPSU, Ministry for Health in partnership with the local industry, to ensure security of supply for these medicinal products. 

2. There is an ongoing process on an international level to identify alternative sources to the UK supply chain and to identify alternatives from other EU member states.

The same exercise is being undertaken for the medical devices and consumables where products are exported through UK and where there is a UK notifying body.  The latter is problematic not only for Malta and in fact other Member states asked for a grace period with respect to medical devices certificates validity in the event of Brexit in order not to disrupt access.

It is pertinent to note that the CPSU has been taking all possible measures to ensure the unhindered flow of procurement of medicines and medical devices/consumables required by the National Health System (NHS) with minimal administrative or legislative bureaucracy. In the past years CPSU, MFH, has successfully acted to eradicate Out of Stock issues, and it is critically important to retain this positive track-record for the well-being of the patient. The Ministry for Health has also taken proactive action and tasked the Medicines authority to engage with the private industry to solicit co-operation for the availability of adequate supply of medicinal products not falling within the competence of the NHS. May we kindly re-assure the general public that the Government is committed to guarantee availability of treatment for the Maltese population as it has been doing throughout these years.

Ing Karl Farrugia

Managing Director

Souring & Supply Chain Management

Central Procurement & Supplies Unit

Ministry for Health