Pharmacy sector calls for moratorium on FMD sanctions at implementation

The pharmacy sector should be given a “period of grace” on sanctions after the Falsified Medicines Directive (FMD) implementation date to allow for the new processes and procedures to be embedded in daily routines, the Royal Pharmaceutical Society (RPS) has said.

The RPS was responding to the Medicines and Healthcare products Regulatory Agency’s (MHRA) consultation on implementing ‘safety features’ under the Falsified Medicines Directive, which closed on 23 September 2018.

The consultation said the government was “minded to move to an approach that would use a mixture of both criminal and civil sanctions”. Under this regime, non-compliant bodies or individuals would initially face civil sanctions, including written warnings and civil fines. Only the most serious breaches would be subject to criminal sanctions. In its response, the Society voiced support for this approach, saying that it would allow for a lenient approach to inadvertent breaches.

Malcolm Harrison, chief executive of the Company Chemists Association (CCA), warned that Brexit could complicate the introduction of the FMD.

“Community pharmacy businesses, and wider pharmacy, do not know how long they will have access to the FMD system, because we do not know what agreement the UK government and EU will come to in this area,” said Harrison.

“Pharmacy businesses are nevertheless having to enter into legal agreements with FMD system suppliers and make financial investments in IT, staff training and other elements of their operational platforms despite not knowing if they will be required on an ongoing basis.”

The sector should be compensated for the costs of redundant investment if the UK medicines verification system is disconnected from the European hub after Brexit, Harrison added.

Other bodies agreed that civil rather than criminal sanctions should be used in most cases of non-compliance, including the Pharmaceutical Services Negotiating Committee, which said that criminal sanctions should only apply in exceptional circumstances, such as intentional fraud.

The Guild of Healthcare Pharmacists said it would “fully support the indication that criminal sanctions will only be used in cases of intentionally fraudulent breaches”.

“We do however feel it is important that criminal sanctions are in place in order to safeguard public confidence in the medicines supply chain,” it added.

Community Pharmacy Scotland (CPS) said it would like to see a similar approach to that used in enforcement of the General Data Protection Regulation, and suggested that “if community pharmacists can demonstrate they have the appropriate systems and thinking in place for FMD, then the regulator should be proactive and pragmatic, aware of business needs and the real world”.

Warwick Smith, director general of the British Generic Manufacturers Association and the British Biosimilars Association, said the sanctions regime needed to be “timely and to have sufficient rigour” across the entire medicines supply chain.

“The FMD is for the benefit of public health, therefore its implementation should be enforced equally at each point of the medicines supply network, up to the point at which the individual patient receives their medicine,” said Smith. 

Raj Patel, chair of the UK FMD working group, urged all community pharmacies to start planning for FMD immediately. 

”The community pharmacy sector needs to move quickly,” said Patel.

“Irrespective of any Brexit confusion and whatever our post-Brexit position might be, we need to have a viable solution by the February 9 deadline.

“FMD aims to make medicine falsification detectable and uneconomic. We recognise contractors will need to make substantial time and investment, but it is important that community pharmacy meets its obligations.”

The UK FMD working group comprises experts from the CCA, CPS, PSNC and the National Pharmacy Association.