Decades-old Pharmacy Act being modernised

A new Pharmacy Bill has been gazetted to replace a 45-year-old law dealing with medications in the Cayman Islands.

The bill repeals and replaces the Pharmacy Act of 1979 with a new regulatory regime for the import, manufacture, wholesale, dispensing and prescribing of medicines, according to the Memorandum of Objects and Reasons published alongside the proposed bill in the Government Gazette.

A bill to update the 1979 legislation was passed in 1991, but that law was never brought into force.

The latest bill was published online and opened for public consultation in September.

The Ministry of Health stated at the time, “The legislation is needed in order to respond to the current needs of the community by ensuring that medicines imported are of the highest quality.”

Some new offences are created in the bill, 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.

Under the revised legislation, unlike at present, the Pharmacy Council would not be required to approve each individual medicine that may be used in Cayman. Instead, it can approve medicines if it is satisfied they meet specified requirements, such as if a corresponding authority of a 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 with no physical premises on island.

It also contains a clause that authorises pharmacists to dispense prescription-only medicine, “if they do so in accordance with a prescription issued within the previous twelve 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 prohibits the dispensing of samples of prescription-only medicines, except in
accordance with the regulations.

There have been a number of attempts to update the Pharmacy Act over the years. Following the failure to enact the 1991 legislation, two decades later in 2011, a Pharmacy Council sub-committee submitted suggestions for revisions to the law, but those suggestions were not incorporated into the legislation.

In 2017, then Health Minister Dwayne Seymour told the Legislative Assembly that efforts were being made to update the legislation to “provide for prescription drugs monitoring”, in response to misuse and abuse of prescribed drugs.

In January 2019, Parliament’s Finance Committee was informed that an updated Pharmacy Law was being drafted and was expected to be submitted to Cabinet within two months to be approved for public consultation. It has taken another five years for a draft to be finalised and ready to be considered by lawmakers.