Brexit and the shortage risk in UK

The still uncertain situation of the exit of United Kingdom from the European Union is having negative effects on the economies of all the States involved. The pound is at its lowest level and the EU must face great expenses for re-organisation: for the moment, Brexit seems not to benefit anyone at all.

Especially the absence of a specific date (it is not sure yet whether UK will exit on 31 October or if a new postponement will be required) and the indecision on the terms for the exit (the deal already discussed has not been approved by the British Parliament and the thorny question of the Irish border backstop is still open), all add further uncertainty to a situation that has been going on for too long.

Such uncertainty inevitably invests also the manufacturing, registration and sale of medicinal products.

In view of a no-deal exit from the EU, the United Kingdom had introduced a legislation to cover a possible shortage of drugs on the British market.

The British government has introduced the possibility to issue a specific protocol to address the shortage (SSP – Serious Shortage Protocol): the special measured provided include granting to pharmacists special powers to substitute medicines they are not able to supply with other drugs, that must not necessarily contain the same active principles.

This is a decision with no precedents allowing pharmacist to override doctors’ prescriptions in case of serious drug shortages, provided that the relevant SSP has been issued. The norms do not include a definition of ‘serious shortage’, however the protocol seems to apply to cases of possible shortage when all other expected preventive measures produce no effect.

The SSP is issued, obviously, only in case of serious shortage of e medicinal product on the market of the United Kingdom, if such shortage is a threat for the health of patients. However, it is a measure to be implemented only in case of actual need, when the British Health Department and the pharmaceutical industry are not able to find the drug in any other way and nowhere else.

Moreover, the norm provides for that the decision-making process takes into account the opinion of the Ministry of Health and of the relevant experts; the protocol should also specify the alternative products and the relevant dosage to provide indications to the pharmacies that will supply it. Finally, it must be considered that the substitution cannot be suitable for all groups of patients and relevant precautionary measures are to be taken.

While waiting for the deadlock between UK and EU to unblock, the wish is that such situations are never reached and that all preventive measures put in place are sufficient to ensure the right to healthcare of British and European patients.