My Pharmacy LLC v The Minister of Health the Chief Medical Officer the Pharmacy Inspector
| Jurisdiction | Bermuda |
| Judge | Hargun CJ |
| Judgment Date | 22 November 2023 |
| Court | Supreme Court (Bermuda) |
| Year | 2023 |
| Docket Number | CIVIL JURISDICTION 2023: No. 182 |
[2023] SC (Bda) 88 Civ.
The Honourable Chief Justice Hargun
CIVIL JURISDICTION 2023: No. 182
In The Supreme Court of Bermuda
Mr Kyle Masters and Ms Mahogany Bean, Carey Olsen Bermuda Limited for the Applicant
Ms Shakira Dill-Francois, Deputy Solicitor General for the Respondents
Whether the Chief Medical Officer (in his capacity as the Registrar) has the statutory authority to conduct annual and unannounced inspection of registered pharmacies; whether the Chief Medical Officer has the statutory power to require a successful inspection prior to issuing a registered pharmacy with a Certificate of Inspection; whether the Chief Medical Officer has the statutory authority to publish a list of registered pharmacies indicating pharmacies which have not obtained the annual Certificate of Inspection
These judicial review proceedings relate to the decision of the Chief Medical Officer (“ CMO”), in his capacity as the Registrar with respect to registered pharmacies under the Pharmacy and Poisons Act 1979 (“ the Act”), to publish a Register of Pharmacies dated 25 May 2023 which included a column referencing whether each pharmacy on the register had a valid annual Certificate of Inspection (“ Certificate”) and that My Pharmacy LLC (“ the Applicant”) did not have such a Certificate. The Applicant seeks, inter-alia, the following relief:
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(1) An order of certiorari quashing the decision of the CMO to publish on 25 May 2023 in the Official Gazette a Register of Pharmacies (“ the Second List”), including the Applicant inferring that the Applicant does not have a valid Certificate and is therefore in breach of its regulatory or other obligations and/or is otherwise not a registered pharmacy.
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(2) An order of mandamus requiring the CMO to amend the Second List to remove the reference to a Certificate and any other suggestion that the Applicant is not in compliance with its regulatory obligations as required by section 16 and 17 of the Act.
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(3) A declaration that there is no requirement for any pharmacy to be issued a Certificate by the CMO or the Third Respondent, as there is no legal basis for such a Certificate found in Bermuda law.
The factual background to these proceedings is set out in the two affidavits of Dr Olivia Benyak-Pitcher, the Chief Pharmacist and a director of the Applicant and the affidavits sworn on behalf of the Respondents by Elizabeth Harrington, a pharmacy inspector appointed under the Act and the affidavit of Dr Ayoola Oyinloye, who was appointed as the CMO on 12 August 2020.
In her first affidavit Dr Benyak-Pitcher states that the Applicant opened its business operations in November 2019. She explains that the business model of the Applicant is to provide patients with specialty medicines at reasonable prices. The Applicant specialises in the supply of medicines to patients suffering from life-threatening illnesses, debilitating conditions and hard to obtain medications due to global shortages and regional restrictions. The Applicant is the sole supplier on the Island for many of these critical medicines in some instances and others, the Applicant's pricing allows patients to obtain the medicines they require where there would otherwise be unable to afford them.
The First Respondent is the Minister of Health, who leads the Ministry of Health, and is responsible for Bermuda's healthcare system. The Second Respondent is the CMO and is responsible for the pharmacy inspectors and has specific responsibility for maintaining and updating a list of registered pharmacies, pursuant to section 16 of the Act. The Third Respondent is shown as the Pharmacy Inspector, a person appointed under the Act for the purposes of ensuring that the registered pharmacies are in compliance with various provisions of the Act.
Dr Benyak-Pitcher explains that the CMO published a list of registered pharmacies in Bermuda on 11 May 2023 (“ the First List”) which did not include the Applicant, suggesting that the Applicant was not a registered pharmacy. However, on 25 May 2023 the CMO published a further list of registered pharmacies, the Second List, which comprised two columns setting out the names of “registered” pharmacies and whether they were in possession of a valid Certificate. The Second List includes the Applicant in column 1 and indicates that the Applicant does not have a valid Certificate, with the word “no” appearing in column 2 next to “My Pharmacy”. Dr Benyak-Pitcher understands that the only other pharmacies appearing on the Second List with a “no” in column 2 next to their name are pharmacies which do not operate currently. It appears that the First List was removed from publication on the Bermuda Government website.
Prior to the appearance of the Second List, Dr Benyak-Pitcher explains that on 24 March 2023, the Inspector attempted to conduct an unauthorised inspection of the premises of the Applicant. The Inspector was accompanied by an individual who she recognised as a former inspector, Mrs Lynanne Bolton. Upon their arrival Dr Benyak-Pitcher advised them that they would not be able to inspect the premises unless they presented her with their credentials, as required by section 51(3) of the Act. Mrs Bolton indicated that she had her credentials and was willing to provide them. However, the Inspector stated that she does not need to present credentials and that she should be allowed to inspect. The Applicant offered Mrs Bolton permission to inspect but did not allow the Inspector to inspect without credentials or authorisation. The Inspector left with Mrs Bolton and stated that the Applicant will be sent a letter as she had been denied inspection of the pharmacy.
Dr Benyak-Pitcher complains that the Second List is currently having significant adverse repercussions on the Applicant's business and the Applicant is currently suffering significant damage as a result of this regulatory uncertainty. She explains that the vendors and suppliers are questioning whether they can deal with the Applicant because it appears from the Second List, that there is no valid Certificate and thereby suggesting that it is non-compliant with Bermuda's laws and regulations. The Applicant has already received correspondence and communications from the vendors that they are unable to supply medicines on the basis of the Second List. The Applicant's reputation is currently being tarnished as a result of this uncertainty, vendors and suppliers' trust and confidence in the Applicant is being lost.
Dr Benyak-Pitcher states that the Applicant has suffered monetary losses as a result of this decision. The Applicant had agreements with at least one vendor to be supplied with medicines on a wholesale basis at a particular price point. As a result of the decision, this vendor has refused to deal with the Applicant forcing the Applicant to find alternative sources. Further, as a result of vendors refusing to supply the Applicant with medicines, patients' lives and health are being placed at risk. The Applicant is the sole importer of many of these medicines.
The present application by the Applicant raises following legal issues under the Act:
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(1) Do the inspectors appointed under the Act have wider powers to enter the premises of any registered pharmacy in relation to an annual inspection than the power set out in section 51(3) of the Act. Specifically, does an inspector have the power to enter the premises of a registered pharmacy at will and without notice; and without having to comply with the statutory requirement under section 51(3) of producing his credentials.
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(2) Does the Act provide statutory authority to the Registrar (the CMO) to conduct annual inspections of the pharmacies on the register kept under section 16(1) of the Act; and does it provide statutory authority to the Registrar (the CMO) to issue annual Certificates in respect of the said pharmacies and publish the results in the form of Second List.
Registration of pharmacies is provided for in Part IV (sections 16 to 21) of the Act. The relevant statutory provisions provide:
Register of pharmacies
16 (1) The Registrar shall establish and maintain a register of pharmacies for the purposes of this Act.
Registration of premises as registered pharmacies
17 (1) Where an application for the registration of premises as a registered pharmacy is made by any person (hereafter in this Part called an “applicant”) to the Registrar on the prescribed form accompanied by the appropriate fee, the Registrar shall, subject to sections 18, 20 and 21(1), enter the prescribed particulars relating to those premises in the register of pharmacies.
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17(4) A list of registered pharmacies shall be published annually in the Gazette so soon as may be after the 1st day of January, and particulars of any alteration made in the register of pharmacies on or after that date in any year shall also be published in the Gazette.
Unfit premises: registered pharmacies
19 (1) Where the Minister is of opinion that a registered pharmacy fails in a material respect to comply with the requirements of regulations made under section 22(1)(a) which are for the time being in force, the Minister shall serve on the operator of the pharmacy a notice stating his intention to issue a certificate of unfitness under this section in respect of the pharmacy, and the Minister's reasons therefor; and section 18(3) to (6) shall have effect mutatis mutandis in relation to notices and certificates under this section as they have effect in relation to notices and certificates of unfitness under that section.
Appeals
20 (1) Any person aggrieved by the issue of a certificate of unfitness...
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