Malta’s Pharmaceutical Sector Prepares For The Medicinal Marijuana Growth Industry
August 5, 2021The Medicines Authority expressed dedication to adhere to stringent regulations when asked about its role as regulatory body, emphasising that it is building capacity to be able to carry out its responsibilities according to the Bill.
The production of medicinal cannabis might be “a challenge for the regulators” when it comes to ensuring that the provisions of the new law, that legalises the production of medicinal cannabis, are adhered to, according to pharmaceutical industry operator Pharmaconsulta Ltd.
Andrew Corrieri, regulatory consultant and chief executive officer of Pharmaconsulta Ltd, an independent consultancy firm based in Malta specialising in pharmaceutical regulatory affairs, stressed that monitoring activity in the industry – and determining that there are no breaches – is essential; each unit must be accounted for, in the same way that other controlled substances are.
However, Mr Corrieri emphasised that the Medicines Authority inspectors’ high standards of professional conduct are world-renowned, with local inspectors even having the authorisation to grant US Food and Drug Administration (FDA) approval as well as EU General Manufacturing Practice (GMP) certification. “The inspectors are known to be some of the strictest in Europe,” Mr Corrieri stated.
This is just as well since the new legislation authorises the regulatory body – the Medicines Authority itself – to review and monitor “relevant operations within premises” and decrees that it shall “have the right at all reasonable times to enter and inspect any premises.” Moreover, a Licensing Appeals Board, consisting of a Chairperson and three members appointed by the Ministry of Health will be set up.
The Medicines Authority expressed dedication to adhere to stringent regulations when asked about its role as regulatory body, emphasising that it is “building capacity to be able to carry out its responsibilities according to the Bill and to support the Superintendent of Public Health in providing scientific, technical and regulatory expertise in the field”.
Moreover, in a separate press release issued by the Ministry for the Economy, Investment and Small Businesses, the government expressed its optimism in the future of this industry, stating that the introduction of the production of medical cannabis “will further strengthen the manufacturing sector of pharmaceuticals in Malta whilst making it simpler for Maltese patients to have easier and safer access to medication.”
This drive towards increased investment – and options for the patient – is positive, according to Mr Corrieri, but he believes there is a need for quotas when it comes to supply on the local market. This would be based on calculations involving the number of patients who would require the medication, as well as an estimation of how much they would require.
In the meantime, six projects have already been approved – according to a press release issued by the Ministry for the Economy, Investment and Small Business – with investors hailing from Canada, Australia and Israel and a total capital investment of €40 million. The creation of more than 200 new jobs is also expected. The press release also stated that “interest from other countries continues to grow” following the approval of the legislation. When asked to provide more specific details on how many companies have recently expressed interest, and their provenance, following the approval of the bill, a spokesperson for Malta Enterprise stated that it “is in discussions with key foreign players engaged in the production of medicinal cannabis” but that the “names and status of enquiries cannot be divulged due to confidentiality provisions.”
The growing number of work opportunities within the sector has also come as a welcome development by the pharmaceutical industry. Indeed, Mr Corrieri believes that Malta’s expertise in this area helped to attract this new business to the island. This was corroborated by the Medicines Authority who, while highlighting that “the medicinal cannabis industry is an industry with specific needs and facilities”, expressed their “full confidence that the capabilities of Maltese personnel” will once again prove of immense value, as they did “during the establishment of the pharmaceutical industry in Malta.”
When asked about the diversity of jobs which the production of medical cannabis could generate, Mr Corrieri went on to assert that the industry would require an increased laboratory workforce – due to the necessity of providing companies with European batch release certification. There will also be a need for medical reps and pharmacy personnel, such as pharmacy technicians, though Mr Corrieri pointed out that the latter were being catered for, especially thanks to the undergraduate Bachelor of Science in Pharmaceutical Technology (Honours) provided by the University of Malta.
Yet, he noted the shortage of qualified personnel (QPs) who are responsible for signing off on the EU certification, which would allow these companies to operate on the continent and in markets which traditionally do business with Europe, such as the Middle East. He emphasised that the industry is already suffering from a lack of QPs since “this also depends a lot on experience” and stressed that the system needs to provide for this by, perhaps, subcontracting QPs and making the training process faster. However, he emphasised that “the lack of QPs should not stop investment.”
Indeed, in a move which seems to be working to address this, the Medicines Authority is currently “working closely with the Department of Pharmacy at the University of Malta and the Ministry for Education and Employment to support the requirements of the pharmaceutical industry” in terms of training and education. In its statement, it pointed to the myriad courses offered by the University of Malta, further emphasising that stakeholders themselves are “invited to support these courses.”
As an example of the way the education and industry are linked, it also referred to a recent Doctorate in Pharmacy graduate, with vast experience in the regulatory sciences, who recently joined the pharmaceutical industry as a QP for Pharmacovigilance. It also referred to the successful fellowship programme, established by the Medicines Authority, which encourages students to obtain qualifications in much-needed areas, and noted that the Department of Pharmacy is also supporting Mater Dei Hospital to expand the clinical pharmacy services which require immediate expansion in order to provide the relevant training. The professionals who emerge from these initiatives “will be an important contribution to making Malta a centre of excellence for cannabis research,” the Medicines Authority concluded.
This article originally appeared in The Malta Business Observer
The Medicines Authority expressed dedication to adhere to stringent regulations when asked about its role as regulatory body, emphasising that it is building capacity to be able to carry out its responsibilities according to the Bill.
The production of medicinal cannabis might be “a challenge for the regulators” when it comes to ensuring that the provisions of the new law, that legalises the production of medicinal cannabis, are adhered to, according to pharmaceutical industry operator Pharmaconsulta Ltd.
Andrew Corrieri, regulatory consultant and chief executive officer of Pharmaconsulta Ltd, an independent consultancy firm based in Malta specialising in pharmaceutical regulatory affairs, stressed that monitoring activity in the industry – and determining that there are no breaches – is essential; each unit must be accounted for, in the same way that other controlled substances are.
However, Mr Corrieri emphasised that the Medicines Authority inspectors’ high standards of professional conduct are world-renowned, with local inspectors even having the authorisation to grant US Food and Drug Administration (FDA) approval as well as EU General Manufacturing Practice (GMP) certification. “The inspectors are known to be some of the strictest in Europe,” Mr Corrieri stated.
This is just as well since the new legislation authorises the regulatory body – the Medicines Authority itself – to review and monitor “relevant operations within premises” and decrees that it shall “have the right at all reasonable times to enter and inspect any premises.” Moreover, a Licensing Appeals Board, consisting of a Chairperson and three members appointed by the Ministry of Health will be set up.
The Medicines Authority expressed dedication to adhere to stringent regulations when asked about its role as regulatory body, emphasising that it is “building capacity to be able to carry out its responsibilities according to the Bill and to support the Superintendent of Public Health in providing scientific, technical and regulatory expertise in the field”.
Moreover, in a separate press release issued by the Ministry for the Economy, Investment and Small Businesses, the government expressed its optimism in the future of this industry, stating that the introduction of the production of medical cannabis “will further strengthen the manufacturing sector of pharmaceuticals in Malta whilst making it simpler for Maltese patients to have easier and safer access to medication.”
This drive towards increased investment – and options for the patient – is positive, according to Mr Corrieri, but he believes there is a need for quotas when it comes to supply on the local market. This would be based on calculations involving the number of patients who would require the medication, as well as an estimation of how much they would require.
In the meantime, six projects have already been approved – according to a press release issued by the Ministry for the Economy, Investment and Small Business – with investors hailing from Canada, Australia and Israel and a total capital investment of €40 million. The creation of more than 200 new jobs is also expected. The press release also stated that “interest from other countries continues to grow” following the approval of the legislation. When asked to provide more specific details on how many companies have recently expressed interest, and their provenance, following the approval of the bill, a spokesperson for Malta Enterprise stated that it “is in discussions with key foreign players engaged in the production of medicinal cannabis” but that the “names and status of enquiries cannot be divulged due to confidentiality provisions.”
The growing number of work opportunities within the sector has also come as a welcome development by the pharmaceutical industry. Indeed, Mr Corrieri believes that Malta’s expertise in this area helped to attract this new business to the island. This was corroborated by the Medicines Authority who, while highlighting that “the medicinal cannabis industry is an industry with specific needs and facilities”, expressed their “full confidence that the capabilities of Maltese personnel” will once again prove of immense value, as they did “during the establishment of the pharmaceutical industry in Malta.”
When asked about the diversity of jobs which the production of medical cannabis could generate, Mr Corrieri went on to assert that the industry would require an increased laboratory workforce – due to the necessity of providing companies with European batch release certification. There will also be a need for medical reps and pharmacy personnel, such as pharmacy technicians, though Mr Corrieri pointed out that the latter were being catered for, especially thanks to the undergraduate Bachelor of Science in Pharmaceutical Technology (Honours) provided by the University of Malta.
Yet, he noted the shortage of qualified personnel (QPs) who are responsible for signing off on the EU certification, which would allow these companies to operate on the continent and in markets which traditionally do business with Europe, such as the Middle East. He emphasised that the industry is already suffering from a lack of QPs since “this also depends a lot on experience” and stressed that the system needs to provide for this by, perhaps, subcontracting QPs and making the training process faster. However, he emphasised that “the lack of QPs should not stop investment.”
Indeed, in a move which seems to be working to address this, the Medicines Authority is currently “working closely with the Department of Pharmacy at the University of Malta and the Ministry for Education and Employment to support the requirements of the pharmaceutical industry” in terms of training and education. In its statement, it pointed to the myriad courses offered by the University of Malta, further emphasising that stakeholders themselves are “invited to support these courses.”
As an example of the way the education and industry are linked, it also referred to a recent Doctorate in Pharmacy graduate, with vast experience in the regulatory sciences, who recently joined the pharmaceutical industry as a QP for Pharmacovigilance. It also referred to the successful fellowship programme, established by the Medicines Authority, which encourages students to obtain qualifications in much-needed areas, and noted that the Department of Pharmacy is also supporting Mater Dei Hospital to expand the clinical pharmacy services which require immediate expansion in order to provide the relevant training. The professionals who emerge from these initiatives “will be an important contribution to making Malta a centre of excellence for cannabis research,” the Medicines Authority concluded.
This article originally appeared in The Malta Business Observer
