Pharmacy Bill

Overview

The proposed Bill seeks to ensure and facilitate the proper regulation of the pharmacy practice. This long-awaited piece of legislation will intentionally repeal and replace the Pharmacy Act, 1979 and the Pharmacy (Poisons and Restricted Pharmaceuticals) Regulations (2017 Revision). It provides for the comprehensive control, quality and safety of various types of medicines. When the Bill becomes an Act, it will uphold the highest standard of pharmaceutical services for the Cayman Islands community.

The updated Bill will facilitate the monitoring and regulation of the pharmacy practice as the Bill will, among other things:

• Classifying medicines;
• Provide clear rules on the proper handling and supply of medicines;
• Establish a system for applications to the Pharmacy Council for licences for various activities;
• Regulate the manufacturing, wholesale, importation and dispensing of medicines.

Why your views matter

The Pharmacy Bill, 2023 will close gaps due to the existing Pharmacy Act being so outdated. The Bill provides clear categorisation, proper handling, and storage of medicines, including their importation and distribution. It will ensure the proper regulation of all persons holding a manufacturing, wholesale or dispensing licence. It assigns further responsibilities to the Pharmacy Council in addition to their duties attributed in Section 21 of the Health Practice Act (2021 Revision). More importantly, the Bill ensures that the law will be successfully implemented due to the appointment of inspectors for enforcement purposes. 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, and to stem the importation of medicines by people without the appropriate authority/licence, thereby enabling the advancement of pharmacy practice locally. 

Key Benefits of the Bill

• Creates minimum standards for:
  • import
  • storage
  • wholesale
  • manufacturing
  • prescribing
  • and dispensing of medicines
• Ensures quality and safety of medicines imported into the Cayman Islands by meeting international standards
• Ensures additional safeguards to reduce importation of substandard and unregistered medicine
• Gives the Pharmacy Council the ability to issue various licenses to address the safety and reliability of medicines manufactured, imported, supplied and/or distributed through a wholesaler
• Strengthens relationship with Customs and Border Control (CBC) helping to identify counterfeit or illegal importation of medicines
• Addresses threat posed by the illicit abuse/use of narcotic drugs
• Balances the demand for and supply of narcotic drugs and psychotropic substances for legitimate purposes.

What are Some Key Changes/Updates of the Bill?

• In the case of national health emergencies, the Bill empowers Cabinet to issue an emergency use authorisation for a non-approved medicine. 

• The Pharmacy Council will have the power to issue an exceptional use authorisation for a non-approved medicine.

• Medicines that are already approved in a country prescribed by regulations will not require further approval for importation to the Cayman Islands.

• The Pharmacy Council may issue, suspend or revoke licences depending on the conditions associated with each application.

• It establishes clear rules on the types of medicines and who is allowed to import, manufacturer, wholesale, dispense or distribute. These are classified as prescription only medicines and pharmacy medicines.

• Pharmacies are not allowed to stock medicines with leaflets not written in English.

• Pharmacists are given authority to dispense an emergency supply of a prescription-only medicine without a prescription if the medicine is not a narcotic and is essential in maintaining the patient’s life or continuing therapy for a chronic condition.

• Currently the prescribers under the Bill who can prescribe medicines include a medical doctor, dentist and veterinary surgeon. It is hoped that, once the regulations are completed, other registered practitioners, such as pharmacists and nurse practitioners, will have prescribing rights.

• It facilitates the appointment of inspectors and empowers them to enforce certain stipulations outlined in the Bill. 

Is this Bill only for Pharmacists and Pharmacy Technicians?

No. It applies to all registered health care practitioners, not just Pharmacists and Pharmacy Technicians. It also impacts manufacturers, wholesale providers, consumers, pharmacies and regulatory authorities. 

If I witness a person committing offences described in the bill, where do I make a report?

Send a formal, written complaint to the Pharmacy Council so that the matter can be investigated.

How do I obtain a manufacturing, importing or wholesaling license?

Submit your application to the Pharmacy Council within the Department of Health Regulatory services at the Government Administration Building. You can access application forms and other important information on their website at www.gov.ky/dhrs. They can also be contacted via email: hpbusers@gov.ky or by phone at (345) 949-2813. Once your application and other documents have been received, a decision will be provided by the Council.

Can a pharmacy inspector appear unannounced?

(a)    If it is a non-residential place, the inspector will provide notice to the owner of their intention to inspect before doing so. 
(b)    If it is a residential place, the inspector cannot enter unless the following criteria is satisfied: 

(1) the inspector has provided written notice to the owner informing them of their intent to enter and
(2) the owner has given permission either orally or in writing for the inspector to enter the premises  or
(3) the inspector has been given authorization to enter the premises by way of an warrant issued by a Magistrate. 

What happens next

How Your Information Will/Might Be Used

The Bill is currently in the public consultation phase with the aim of receiving vital feedback from the people of the Cayman Islands. During this phase, the general public is made aware of the intentions of the Bill and are able to ascertain how they will be impacted. The Ministry of Health & Wellness will closely monitor and compile all the feedback that is received. The feedback will then be used to improve and clarify concepts, procedures or provisions within the Bill. Once approved by Cabinet, the Bill will be debated by the elected representatives on the floor of Parliament.