MP calls for inquiry into General Pharmaceutical Service

Labour MP Evarist Bartolo yesterday called on the Auditor-General to hold an investigation into the General Pharmaceutical Service, which spends Lm1m every month on the purchase of medicines.

Mr Bartolo said in parliament that there had been no reaction yet to remarks he made in the past about irregularities in the General Pharmaceutical Service, including how bagfulls of medicines, some of them dangerous, were abusively handed to people who were not entitled to them so that they could then distribute them like Father Christmas handing out presents.

Mr Bartolo was speaking during the debate on the Medicines Act, The debate on the bill started on Monday. The bill introduces a new structure for the regulation of medicines and pharmacies.

Dr Michael Farrugia, opposition spokesman on health, resuming his speech from Monday's sitting, said it was clear that the price of medicines would be rising three times in the near future - because of the costs connected with the registration of medicines, the adoption of the euro, and the imposition of VAT at five per cent.

Dr Farrugia observed that the government's Medical Stores already owed some Lm6.8m to suppliers. How would this growing sum be paid off when fewer funds had been allocated for this purpose this year and when public spending had to be cut back further if the deficit was to be controlled?

Mr Michael Bonnici (PN) said this was a revolutionary law and a fresh start from the century-old Medical and Kindred Professions Act.

He thanked the Chamber of Pharmacists for its study of the bill and said amendments should also be discussed with the chamber.

The chamber, he observed, was critical of the setting up of two authorities - the Licensing Authority and the Medicines Authority. But it was clear that both these bodies were necessary.

The Superintendent of Public Health would be the Licensing Authority, whose role would be regulatory.

The Licensing Authority's role, among other things, would be to establish regulations and issue licences for pharmacies and set standards for the manufacture, assembly, packaging, labelling and wholesale distribution of medicinal products.

The same authority would also establish procedures for clinical trials and the testing of medicinal products and it would establish procedures for the reporting of adverse reactions.

Other purposes of this authority included the regulation of advertising.

The Medicines Authority would be more focused on medicines and have an executive role, ensuring that locally manufactured or imported medicines were of the proper standard.

He felt that the chief executive of this authority should be the Chief Pharmacist.

The roles of this authority included assisting and advising the Licensing Authority and establishing procedures on the safety, quality and efficacy of medicinal products sold in Malta. All this underlined the important role of professional pharmacists to ensure that medicinal products on the market were of a high standard and they were administered well.

Turning to the Medicines Review Board, Mr Bonnici observed that the chairman had to be a lawyer and the other two members had to be competent in various fields as listed in the bill. Since there could be areas where experts may not necessarily be pharmacists, such as in the case of herbal medicine, the bill should allow for the members to be substituted according to the subject under consideration by the board.

Mr Bonnici noted that in terms of the bill, medicinal products could not be put to the market without authorisation by the Licensing Authority. But the minister needed to explain how the bill also provided that in exceptional cases, the authority could allow the use of a medicinal product without a marketing authorisation.

Mr Bonnici observed that the minister in his introductory speech had said that Malta imported 10,000 different medicinal products. There was no doubt that the Maltese used too many antibiotics, with many of them being wrongly sold over the counter without doctor's prescription. Clearly there was need for greater control in this area.

There should also be an annually updated list of medicines which could be sold over the counter.

Mr Bonnici said he wanted to insist that medicines were always dispensed professionally. He could understand and agreed with the social role of the government to hand out free medicines, but one also had to consider the need for pharmacists to have a decent income. As things stood, pharmacies were not financially viable solely from the sale of medicines.

Mr Bonnici said some herbal medicines, so-called slimming products, as well as some pain relief products and skin preparations also needed to be authorised and dispensed professionally and not from supermarkets since their use could have particular consequences.

Reacting to opposition remarks, Mr Bonnici said no VAT would be imposed on medicines in the next seven years and if, after that period, an EU country still did not charge VAT on medicines and food, Malta had reserved the right not to impose VAT on those products either.

Mr Bonnici said medicines needed to be dispensed professionally even from government clinics, with the patients being adequately told of how they should be taken, and what side effects could result.

Mr Noel Farrugia (MLP) warned that this bill would increase costs for consumers and the state. It would also increase bureaucracy and reduce Malta's competitiveness.

While it was being claimed that VAT at five per cent would not be imposed at least for the next seven years, new procedures and structures regarding medicines would be introduced upon accession and lead to higher costs. The people should be told of such costs.

Labour MP Evarist Bartolo observed that nearly half of the funds allocated this year for the purchase of medicines would be needed to fund purchases made in the past. This reflected a serious crisis which would be made worse once EU regulations on medicines were brought into force. In future, a increasing portion of funds would have to be allocated for administration, rather than actual purchase and dispensing of medicines.

Mr Bartolo said there had been no reaction yet to remarks he made in the past about irregularities in the General Pharmaceutical Service, including how bagfuls of medicines, some of them dangerous, were abusively handed to people who were not entitled to them so that they could then distribute them like Father Christmas handing out presents.

What was the Health Department doing to instil seriousness in the dispensing of medicines paid for by taxpayers and to ensure there was total security in government stores and medicines were not issued irregularly?

With the government spending Lm1m a month on medicines, surely the Audit Office should investigate the General Pharmaceutical Service?

Mr Bartolo said he shared the remarks of the Chamber of Pharmacists that too many powers were being granted to the Licensing Authority, with not enough transparency and without means of appeal in all cases.

The Chamber was also concerned that medicinal products may end up being sold from establishments that were not pharmacies, and dispensed by people who were not pharmacists. This posed a danger to the public.

The Chamber had rightly called for clear criteria on the opening of pharmacies, an issue which had been dragging for far too long.

Mr Bartolo also called for an updating of the pharmacy course at the university. He insisted that pharmacy students would be able to take part in EU educational courses thanks to a Lm1.5m fund which would be allocated for participation in these programmes.

Mr Silvio Parnis (MLP) insisted that advertising of medicinal products needed to be more adequately monitored and controlled. The end objective should not be to sell more, but to sell the best.

The Labour MP said medicine shortages in government dispensaries caused problems, particularly to elderly people.

He said a review was needed of the yellow and pink card systems for the dispensing of medicines from government pharmacies, particularly since some people were being unfairly denied those medicines while others were receiving them abusively.

Dr Jose Herrera (MLP) said the setting up of the Licensing Authority and the Medicines Authority was yet another blow to the civil service. Clearly, the functions of these new authorities could be handled by the Department of Health.

The Labour MP referred to the composition of the Medicines Review Board and said it lacked teeth. The chairman would be appointed by the minister for three years and he would be eligible for re-appointment. This meant the chairman did not enjoy independence and could end up pleasing the government so that he could be reappointed. In boards such as this, the chairman and members normally had a fixed term during which they could not be removed except for defined reasons. But this was not the case regarding the new board.

Dr Herrera said the government had had to cave in to the EU and would be imposing VAT on food and medicines, something which the MLP was promising it would never do, whatever the EU said.

The Labour MP said a substantial amount of medicines were imported from non-EU countries. The price of such medicines would have to rise when the common external tariff was imposed after EU membership.

Mrs Helena Dalli (MLP) said EU membership would remove the civil service from the drafting of legislation, and the duty of civil servants would only be to implement laws set by Brussels.

Mrs Dalli insisted that the government should heed the comments on the bill by the Chamber of Pharmacists.

Dr Jean Pierre Farrugia (PN), observed that the bill laid down that unless otherwise provided, a medicinal product shall only be sold from a pharmacy, provided that the Licensing Authority may prescribe that a medical product or class or classes of medicinal products, may be sold from premises other than a pharmacy but only in particular circumstances.

It was clear that medicinals would not be sold from places other than pharmacies except in exceptional circumstances. For example, doctors may be able to sell certain vaccines, as was already common practice. And there was no need for oxygen cycliners for medical use to be sold from pharmacies.

Nonetheless, he already knew that the minister intended to further clarify this clause.

There was no doubt that pharmacists would continue to be essential for the medical service as no one could play about with the safety of medicines.

Dr Farrugia insisted that in the advertising of medicinals, it was important that possible side effects were clearly explained.

Dr Farrugia referred to the possible introduction of VAT on medicines at five per cent in seven years time. Seven years, he said, was a long time away and VAT at five per cent was different from 15 per cent. In any case, the government could come up with several measures to counter any increase in prices which such a decision could cause. Malta had also made clear it would continue not to charge VAT if other EU countries did not.

Dr Karl Chircop (MLP) also insisted that implementation of this bill, particularly registration of medicines, would raise the price of medicines even before the imposition of VAT. The increase could be as high as 20 per cent.

A report commissioned by the government showed how health costs for consumers would rise following EU membership, but this was not disclosed to the people.

But organisations such as the Pensioners' Association had already cautioned that the standard of living needed to be safeguarded.

Dr Chircop said that as costs rose, some importers may restrict the choice of medicines, causing further problems to consumers.