New, comprehensive law on medicinal products

The House of Representatives yesterday started debating the Medicines Bill, which covers everything related to medicines including manufacture, distribution, advertising and disposal.

Health Minister Louis Deguara said this was, above all, a bill to better protect the interests of consumers.

He noted that both the opposition and the Chamber of Pharmacists had called for legislation such as this.

This was a bill meant to ensure that all medicines imported or made in Malta were of a proper standard.

Dr Deguara observed that whereas in the UK and Italy, between 5,000 and 7,000 different types of medicines were used, Malta imported 10,000 different types. It would appear that this was happening because it was easier to import medicines here.

He said the bill set up a Licensing Authority, a Medicines Authority and a Medicines Review Board.

The Licensing Authority was the Superintendent of Public Health, whose responsibility it would be to establish standards to ensure the quality, safety and efficacy of medicinal products, to establish standards for the operation of pharmacies and establish standards for the manufacture, preparation, assembly, packaging and labelling of medicinal products.

He would also establish standards for testing of medicinal products, wholesale distribution and advertising as well as issue, renew, amend, vary, suspend or revoke marketing authorisation for medicinal products.

The Medicines Authority would assist the Licensing Authority on the regulation of medicinal products and establish procedures as may be necessary for obtaining and assessing information as regards the safety, quality and efficacy of medicinal products, among other tasks which may be delegated to it by the Licensing Authority.

The Medicines Review Board would hear any appeal from recommendations of the Medicines Authority.

Dr Deguara said both the Chamber of Pharmacists and the Pharmacy Board had expressed reservations on parts of the bill, and a number of amendments would be moved in committee.

The health division, he explained, was divesting itself from the role of a provider and taking on the role of a regulator.

All pharmacies, whether private or public, would have to conform with the bill.

Going into some other parts of the bill, Dr Deguara said no person could place a medicinal product on the market unless granted authorisation from the Licensing Authority. Medicines may only be advertised according to conditions laid down in this law.

Similarly, the law laid down provisions on manufacturer's licences and licensing of wholesale dealers.

Applications for pharmacy licences would henceforth by made to the Licensing Authority.

The bill also lays down how pharmacies should be run.

Dr Deguara said that both this bill and the Food Act had been moved irrespective of Malta's possible accession to the European Union.

Concluding, the minister refuted claims that the bill was de-classifying the pharmaceutical profession. It was a positive sign that even the opposition believed that the registration of medicines system should be introduced for the benefit of the patient.

Opposition spokesman on health Michael Farrugia said it was important that the bill be seen as a form of protection of the consumer, who had a right to receive the best quality medicinals.

He agreed with the minister that this was not a question of EU accession or partnership: in either case the consumer had to be treated as king.

The bill was, however, tied to Malta's entry to the EU. Indeed the government had committed itself to passing this bill by the end of 2001, with the administrative set-up and the registration structure in place by mid-2002. According to EU requirements, provisional licensing had to come in force in 2001.

Dr Farrugia observed that there were certain instances where no appeal could be made from decisions of the Licensing Authority. Why couldn't all decisions by made subject to appeal?

It was important that the functions of the Health Department as regulator and health provider were kept strictly separate.

Dr Farrugia said the number of authorities being created was a burden on the country's finances and certain authorities were uncontrollable insofar as public finances were concerned.

The Licensing Authority could very well have been incorporated under the regulatory powers entrusted to the health division, he said.

In terms of this bill, he observed, a call for tenders had to be issued by the Medicines Authority only if the value of the consignment was over Lm100,000. Yet the requirement in terms of government financial regulations was much lower.

Turning to the Medicines Review Board, Dr Farrugia said he would have liked the chairman, a lawyer, to have more experience than the seven years provided for in the bill.

He hoped that the board would not become another law court with regards to delays.

Dr Farrugia said the opposition agreed in principle with the registration of medicines. This would guarantee quality and curb abuses However, this was an EU-imposed condition and did not allow for the flexibility provided for by Labour's partnership.

Dr Farrugia asked the minister to table the EU membership impact assessment on medicinals, made in 2000, which, he observed, had concluded that the prices of medicines would explode.

The assessment report had also shown that because of the new registration regime, the number of medicinals on the market would decrease and certain medicines would be excluded, even if patients needed them, because their importation would not continue to be financially viable.

With over 70 per cent of the medicinals imported from the EU, and about 25 per cent from the European Economic Area, medicinals, once registered in those countries, should be imported without undue restrictions, Dr Farrugia said.

One also had to keep in mind the effect on prices when Malta would embrace the euro as its currency and when VAT was imposed on medicines.

Dr Farrugia said that the bill did not make any provisions with regards to the confidentially of the dossiers presented by the import companies. He also pointed out that every five years, importers had to pay to renew the licence for the importation of each medicinal. This would keep prices high.

He said that in June 1996 the Nationalist government had officially liberalised pharmacies and these were no longer regulated according to locality and population. Under this legal notice, which was still in force, any European pharmacist could open shop in Malta.

Dr Farrugia called on the minister to table the new tariffs of medicinals before the referendum of March 8.