A revision of the medicine’s procurement procedures recommended

Case Notes investigated by the Commissioner for Health

The complaint

The Times of 7 November 2012, quoted a study conducted by the Swedish based think-tank, Health Consumer Powerhouse, in which it was reported that “Malta scores badly in EU hepatitis study” and that Malta scored “dismally when it came to outcomes and national strategy”. The report continued that “it is evidently clear that hepatitis is not considered to be a priority to Malta”.
In February 2012, Hepatitis B and C, were included in the revised list of the Fifth Schedule of the Social Security Act and therefore patients were, by right, entitled to receive the medication free of charge. As per Legal Notice No 58 of 2009 Section 2(1) “the primary objective of those regulations is the promotion of public health by ensuring the availability of adequate supplies of medical products at a reasonable cost in Government Health Services”.

Taking into consideration the mentioned study, the Commissioner for Health felt the need to investigate this situation further.
Facts and findings The Commissioner wrote to the Chief Medical Officer (CMO) within the Health Department asking to be updated on the action taken to procure the medicines to treat Hepatitis B and C.

In reply to the Commissioner’s letter, the CMO said that the Health Technological Assessments for the medicines in question had been performed. These tests, the CMO continued, would be presented and appraised through the Government Formulary List Advisory Committee (GFLAC). The CMO explained, that the procurement of these medicines could only be initiated if and when the committee recommended the introduction of such treatment onto the Government Formulary list.

The Commissioner queried the procurement process being used which can, according to the CMO, only be initiated after the GFLAC’s recommendations. He argued that once the Government decided to include a disease or condition in the Fifth Schedule of the Social Security Act, the GFLAC’s clearance, should have been obtained before the issuance of the Legal Notice.

In reply to this query, the CMO explained that such action cannot be taken because Regulation 7(a) of the Second Schedule of Legal Notice No 5 of 2009 precluded such procedure.

Recommendations

Following the correspondence with the CMO, the Commissioner wrote to the Superintendent of Public Health recommending an amendment to the procedure in a way that the approval of the GFLAC was obtained before the Legal Notice was issued.

This would eliminate the risk that the GFLAC may decide not to recommend the inclusion of a drug in the Government Formulary List after that the Government would have committed itself through the issue of a Legal Notice.

In his reply the Superintendent of Public Health, explained that while the Legal Notice 58 of 2009, still refers to the Superintendent of Public Health, the responsibilities have been split between the CMO and himself. The Superintendent explained that the responsibility for entitlement issues and the inclusion of medicines into the government formulary fall within the portfolio of the CMO.

Although he was not directly responsible for the procedure, the Superintendent explained that the procedures for the inclusion of a disease condition in the Fifth Schedule of the Social Security Act are distinct and separate from the introduction of a new medicine into the Government Formulary. The latter, he explained, involved the approval of a particular medicine used for the treatment of one or more conditions and therefore made it available for patients to use at no cost. A particular disease was usually amenable to treatment by more than one medicine but the inclusion of such disease in the fifth schedule did in no way imply that all medicines available for the treatment for that particular disease would or should be available free of charge for the patient. Therefore in his opinion, the process should continue to proceed in a distinct way from each other.

To substantiate his argument, the Superintendent quoted Regulation 7(a) of the Second Schedule of LN 58/2008 which states “Entitlement to free medicines shall be as specific in the Social Security Act, Cap. 318, Article 23 and the Fifth Schedule Part II to the same Act regarding Disease and Conditions in respect of which Free Medical Aid may be accorded, as well as medicinal products required for the provision of care within Government Institutions. A medicinal product or a category of medicinal products to treat conditions which fall outside the scope of the Government Health Services may be entirely excluded from the Government Formulary List.”

The interpretation of the quoted regulation given by the Superintendent, was that the inclusion of a medicine in the Government Formulary was not dependent of Schedule V of the Social Security Act. It was the entitlement of an individual to have it free of charge. He continued that the regulation itself stated the need for use of a medical product in the provision of care within Government Institutions was also one of the criteria to be considered by the GFLAC. The Superintendent explained that there were many medicines in the formulary which were used in hospital for the treatment of conditions which were not on Schedule V and if the patient was discharged on such treatment then the patient had to buy such medication.

The Superintendent concluded that the recommendation made by the Commissioner, could only be considered in situations when there was a particular condition which was only treatable by the one and only medicinal product on the market.

From the issuance of the Legal Notice amending the Social Security Act to include treatment for Hepatitis B and C in the revised list of the Fifth Schedule of the Social Security Act, a year had passed, and no action for procurement had been initiated. In this regard, the Commissioner for Health wrote to the CEO of the Central Procurement and Supplies Unit, requesting whether the procurement process has been initiated.

In his reply, the CEO, Central Procurement and Supplies Unit, confirmed that the medicines were not in stock and the procurement process would be only initiated when funds became available.

Conclusions

Following continuous correspondence with the Health Superintendent, the CMO and the CEO of the Central Procurement and Supplies Unit, the Commissioner communicated his conclusions to the CMO. In his conclusions, the Commissioner explained that following consultations with the Parliamentary Ombudsman and the Administrative Consultant to the Ombudsman, all agreed that Legal Notice 58/2008, Schedule II, Regulation 7(a), does not, in any way, impede the Department from taking action to obtain the necessary approvals before a Legal Notice was published to announce the inclusion of a certain disease/condition in Part II of Schedule V of the Social Security Act.

The Public would be more than justified to expect to start receiving the required medicines once the legal notice was published. The Commissioner stated that from a legal point of view, a Legal Notice is binding with effect from the date when it was published and the Department for Health was legally bound to strictly adhere to the contents of the Legal Notice.

Taking this case as an example, the Commissioner proved deficiencies in the system, considering that the Legal Notice to include Hepatitis B and C in Part II of Schedule V was issued in March 2012, and more than a year later the Notice for Tender for the procurement of the medicines required had not been issued.

Therefore, the Commissioner recommended that once the decision to include a disease or condition in Schedule V is taken by the Department for Health, and if the medicines for that particular condition were not already included in the formulary, the necessary approvals were to be sought before the Legal Notice announcing the inclusion of the condition or disease was issued.
The Commissioner explained that if his recommendation is adopted, the Department would be able to take immediate steps for procurement of the medicinal required for the newly added disease.

Outcome

The Commissioner, communicated his recommendations to the CMO, and followed up the issue with the Central Procurement and Supplies Unit, but the medicines needed to treat Hepatitis B and C were not yet available.

In view of this, the Commissioner communicated his recommendation to the Permanent Secretary in the Ministry for Health. The Commissioner stated that after over ten months had passed since the issuance of the Legal Notice, no action had been taken by the Department for Health to procure the required medicines presumably because of financial constraints. This, the Commissioner, concluded was against the law, and the problem had to be addressed without further delay.
The matter will continue to be followed.

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