Pharmacy regulation

In March of this year, the then Health Minister, Simon Hamilton, announced the launch of a public consultation on how regulation of the pharmacy profession in Northern Ireland would be delivered in the future.

Explaining his objective for pharmacy profession, he said ‘I consider that now is the right time to review the current arrangements for pharmacy regulation in NI to ensure that we have modern, fit for purpose arrangements that ensure public safety and which carry public confidence.’

The consultation, which the Minister launched, presented a number of options:

* that regulation of the pharmacy profession would continue to be delivered by the Pharmaceutical Society of Northern Ireland (PSNI), ie, as both a regulator and leadership body

* that a standalone NI regulator would be appointed, or that

* NI would join the current regulatory model operating across the other three UK countries provided by the General Pharmaceutical Council (GPhC)

The history

Since 1925, regulation of the pharmacy profession in NI has been performed by the PSNI, based in Belfast. The Society currently performs the function of both regulation and professional leadership for pharmacists in NI. However, this dual role is counter to modern thinking regarding professional regulation, that to operate effectively in the public interest, a regulator should be totally and demonstrably independent from the profession it regulates.

There are nine healthcare regulators in the UK, consisting of approximately 1.44 million professionals. In comparison with the other UK healthcare regulators, the PSNI, along with the NI Social Care Council, are the only regulators, which retain this dual, potentially conflicting, role.

Simon Hamilton had agreed in principle to split the regulatory and professional leadership functions which were undertaken by PSNI; a move which was backed by the Professional Standards Authority (PSA), who supported the proposals to separate professional regulation and professional leadership.

‘In our view,’ the PSA said, ‘this would be most efficiently and effectively achieved by transferring the regulatory powers of the PSNI to the GPhC. The purpose of regulation is to protect the public, to maintain public confidence in the profession, and to uphold professional standards. Professional leadership works to promote the interests of the profession, and therefore should be separate from any regulatory arrangements. We understand the concerns about a four-country regulator being less in-touch with local issues. In our view, this risk could be mitigated by the governance measures suggested in the consultation document. Furthermore, we believe that the benefits in terms of cost-efficiency, effectiveness and workforce mobility of a UK-wide regulator by far outweigh this risk.

‘Pharmacists are the only healthcare profession in the UK not to have a UK-wide regulator. In our scrutiny of the seven UK-wide regulators we oversee, we have yet to identify any shortcomings in their ability to operate across jurisdictions, and in Northern Ireland in particular. We have no reason to believe that extending GPhC’s remit to NI would have any adverse impact on its ability to effectively protect the public – particularly if the mitigation measures suggested in the consultation document were implemented.’

The PSA also pointed out the benefits that this move to the GPhC would bring to NI pharmacists;

‘It is critical for healthcare economies to make the best use of a mobile workforce, to ensure that communities across the UK have access to the healthcare they need. Having one regulator for all would allow freer movement of professionals around the UK. It would also bring consistency of professional standards and fitness to practise processes, and would be likely to make decisions about registration, removal, and other sanctions fairer and more equitable. This consistency would provide greater clarity for the public.’

From PiF’s discussions with professionals, the general consensus seems to be there are major concerns about the issue– even concerning the quality of the consultation document itself – with some suggesting that it had been ‘rushed through’.

While most pharmacists we spoke to felt that regulation needed to be carried out on a local basis, they were quick to point out that the consultation didn’t actually offer up any ideas as to what this model should look like.

While we await the outcome of this consultation, PiF asked several of the local professional bodies how they felt about both the consultation document and what outcome they’d like to see.

Pharmaceutical Society of Northern Ireland (selection of points taken from response)

While the PSNI wished to place on record ‘that it supports the policy direction set out around the modernisation of pharmacy regulation in NI.’

It would, however, wish to place on record a number of concerns around errors and omissions in the consultation document. The nature of these is such that the analysis of responses may be difficult to uphold.

Firstly, we are concerned that at Paragraph 21, it was suggested that further separation may be required, but no mention is given of the unanimous support for the current arrangement and improved legislation.

The Department has not published the transition costs as we have identified costs of up to £344K associated with the establishment of a UK-wide arrangement and £34K associated with the establishment of NI arrangements, information which we would suggest is a critical consideration for respondents.

Paragraph 34 refers to capacity and resilience of a local arrangement. At the request of the Department, information was provided in detail showing how, at a significantly reduced retention fee, such an arrangement could be delivered in NI. We are disappointed that this concern has been raised when the Department has received financial projections, scrutinised before submission by an independent accountant, which does not support this assertion.

Ulster Chemists’ Association

UCA is most concerned with the pressing need to support the professional leadership of pharmacy Northern Ireland. Whilst the Society has delegated the responsibility for professional leadership to the Pharmacy Forum, many would argue that this has not been given sufficient focus by the Society in relation to its regulatory function.

How professional leadership will be effected by a change to the regulatory system operating in Northern Ireland, or indeed, should the status quo remain, is not addressed in the consultation document.

UCA would welcome clarification from Dept of Health on this issue and we would call on all pharmacists to get more involved in discussions about the future. How would you like to be represented and supported?

Community Pharmacy Northern Ireland (CPNI)

 CPNI, like other organisations recognises the need for separation of the regulatory and representative functions of any regulator organisation. In the event that this is the outcome from the consultation, CPNI is of the clear opinion that the public and the profession in Northern Ireland would continue to be best served by retaining the Pharmaceutical Society of Northern Ireland in Belfast and focussing its role to regulating the pharmacy profession in Northern Ireland.


Future arrangements for the regulation of all healthcare professions across the UK are currently being reviewed and from the discussion at a recent stakeholder event in Belfast hosted by the Department of Health (London), it is clear that the landscape for the regulation of all healthcare professionals across the UK will continue to evolve in the future.


National Pharmacy Association

The NPA believes that the single most important factor in delivering modernised and strengthened statutory regulation is the assurance of public safety. We believe that this consultation does not fully evidence the improvements to public safety which would be envisaged by a UK-wide regulatory arrangement.

The Department must ensure that whatever decision is reached that legislative framework and regulation is fit for purpose in terms of protecting the public as well as enabling innovative and new practice models.

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