Lawmakers have voted to introduce an updated Pharmacy Bill to replace outdated legislation that has been in place for 45 years.
Health and Wellness Minister Sabrina Turner presented the bill to Parliament on Tuesday, pointing out that the current Pharmacy Act, enacted in 1979, was well past its prime.
“To say that this piece of legislation is no longer fit for purpose is an understatement,” she said.
She noted that the Office of the Auditor General, in a November 2021 audit report on the Health Services Authority’s outpatient pharmacy services, had recommended the Pharmacy Act be updated.
That audit report also recommended that a new national strategy for health should be devised. Turner said this strategy was now under way.
She said the pharmacy industry in Cayman had been consulted over the legislative changes and were in support of the amendments.
“The aim is to close unintended gaps and prevent conflicting provisions that currently exist and provide a legal framework for the proper regulation of the pharmacy profession and safety of the people of the Cayman Islands,” she said.
The proposed amendments include the creation of new offences, including the manufacture of medicine without a manufacturing licence; the wholesale of a medicine without a wholesale licence; and the importing, selling by wholesale, dispensing, prescribing, administering or manufacturing of a non-approved medicine.
The legislation, for the first time, allows for the manufacture of medicines in the Cayman Islands.
The revised legislation would no longer require the Pharmacy Council to approve each individual medicine. Instead, the council can approve medicines if they meet specified requirements, such as if a corresponding authority of another country, prescribed by the regulations, approves it.
It also creates provisions for non-approved medicines to be authorised in exceptional circumstances or for a certain duration, as well as emergency-use authorisation, to be issued by Cabinet in the event of a national health emergency.
The law bans internet and mail-order pharmacies that have no physical presence on island.
The bill also authorises pharmacists to dispense prescription-only medicine, “if they do so in accordance with a prescription issued within the previous 12 months (or another prescribed period), and, in the case of a narcotic, in compliance with the requirements of the regulations”.
There are exceptions to this clause for prescribers dispensing to patients under a dispensing licence, for veterinary surgeons dispensing within their scope of practice, and pharmacists dispensing an emergency supply of medicine in specified, restricted circumstances.
The bill also bars the dispensing of samples of prescription-only medicines, except in accordance with the regulations.
The legislation also provides a mechanism whereby the Pharmacy Council can appoint inspectors to enforce the provisions outlined in the Pharmacy Act. Those inspectors would have the powers of entry, search, seizure and inspection. However, they would only be allowed to enter a residence if the owner gives them permission. If consent to entry is denied, the inspector must obtain a warrant from a magistrate.
Leader of the Opposition Roy McTaggart said his party supported the bill, which he said had been “too long in coming”.
Bodden Town West MP and independent opposition member Chris Saunders also noted that this updated legislation was “long overdue”, while Newlands MP and independent opposition member Wayne Panton congratulated Turner for pushing the legislation through to completion.
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