Medicines regulations need democratic oversight says National Pharmacy Association

A bottle of tablets to show Medicines regulations need democratic oversight says National Pharmacy Association

In a formal submission to MPs, the National Pharmacy Association argues that changes to regulations on medicines supply should be subject to parliamentary scrutiny, including rules about hub and spoke dispensing.

The Medicines and Medical Devices Bill, currently being examined by the Public Bill Committee, will confer power to ministers to amend or supplement medicines law, without the need for primary legislation.

A Bill of this kind is seen as necessary to facilitate the uninterrupted business of government following the UK’s exit from the European Union.

However, it also opens up the possibility of important changes to the rules around medicines supply taking place without sufficient parliamentary scrutiny and democratic accountability.

This includes regulatory changes to allow inter-company hub and spoke dispensing, where a pharmacy outsources elements of its dispensing to a third party. The NPA has consistently warned that official claims about the benefits of inter-company hub & spoke are overblown and that it risks diminishing competition and choice in the pharmaceutical wholesale market without a level playing field. Other unintended consequences could be less resilience of the medicines supply system and rises in medicines prices.

NPA Chief Executive Mark Lyonette said: “The changes relating to the safe supply of medicines that could be implemented using secondary legislation empowered under this Bill are significant. Big changes to the way that medicines are supplied to the public could be enacted without the need for further primary legislation.

“What matters to the people of this country should matter to our politicians – and people do care about the safe supply of medicines. We want the provisions of this Bill to require both full consultation with stakeholders and sufficient parliamentary scrutiny.”

The Medicines and Medical Devices Bill will confer power to amend or supplement the law relating to human medicines, veterinary medicines and medical devices; and make provision about the enforcement of regulations. The Bill passed at second reading on 2 March 2020 and is now with the Public Bill Committee.

Following representations by the NPA, an amendment to the Bill was laid this week, which if adopted would limit the power of ministers to amend or repeal provisions in an Act of Parliament using secondary legislation to two years, before requiring Parliamentary approval to extend them.