New licences to be issued for pharmacies

New licences would be issued for the opening of pharmacies, but the criteria of area population and distance from other pharmacies would be observed, Health Minister Louis Deguara told parliament yesterday.

Winding up the debate on the Medicines Bill, he insisted that the Maltese government would not impose VAT on medicines unless Britain and Ireland did so, and even then, the maximum rate would be five per cent, and measures would be taken to obviate any impact on consumers.

The purpose of the bill is to provide for matters connected to the manufacture, preparation, packaging, sale and disposal of medicinal products and the regulation of pharmacies and related pharmaceutical activities. The bill provides for the setting up of a Licensing Authority, a Medicines Authority and a Medicines Review Board.

Dr Anglu Farrugia (MLP), who spoke earlier, said this bill was a replica of what the EU ordered and would create new monster bodies in administration, raising costs for medicine manufacturers and consumers.

Dr Farrugia said that during the EU membership talks, Finance Minister John Dalli had insisted that VAT should not be imposed on medicines, warning it could lead to a one per cent rise in the retail price index and it would affect mostly the elderly and the sick.

The EU had ignored the government and VAT would eventually be imposed on medicines, even if that will be in seven years' time.

Dr Farrugia observed that the members of the Licensing Authority, the Medicines Authority and the Medicines Review Board would all be appointed by the minister and could be removed at any time by the minister, thus enjoying no independence and security of tenure.

Dr Michael Asciak (PN) underlined the importance of the bill to ensure there was control on the quality of medicines. The registration of medicines by the Licensing Authority was a guarantee to patients that the medicines they bought had the desired affect.

Dr Asciak said it was clear that the Chamber of Pharmacists would continue to oversee standards of practice, with the bill augmenting what existed already, such as when the minister, as the regulator of public health, decided to order an inquiry.

Dr Asciak said VAT on medicines would be imposed, at five per cent and not 15, only if Britain and Ireland did likewise within the next seven years. And the government had reserved the right to take measures to ensure that the imposition of this tax did not burden consumers.

Ms Marie-Louise Coleiro (MLP) said the MLP agreed with the registration of medicines but not with other regulations dictating what Malta should do.

The law, Ms Coleiro said, was establishing the Licensing Authority to set standards and the Medicines' Authority to establish procedure. Both functions were regulatory and there was a certain similarity between them, so why not have one set-up?

Would the Licensing Authority, which would actually be the Superintendent of Public Health, have its own staff? What regulations would such staff fall under, especially since the authority did not have its own juridical personality, as the Medicines Authority did?

How would the government ensure that medicines were affordable? According to analyses by the National Statistics Office, the cost of medicines and medical services between 1995 and 2002 had increased by 80 per cent. This affected the most vulnerable people in society including the elderly, the chronically ill and the disabled. Had the government carried out an economic impact assessment of the cost of buying medicine from outside the EU, not using the euro, if Malta became a member of the EU?

The government was saying that should VAT be imposed on medicines, it would give compensation. But compensation measures would be ineffective because of the difference in time between the actual purchase and the time when the compensation filtered through.

Winding up, Health Minister Louis Deguara said the bill had been moved at a time when the Department of Health was changing its role to concentrate solely on regulation. The setting up of the Licensing Authority, as the regulatory authority, would therefore not involve the recruitment of additional staff.

Everyone in the House had agreed that a registration system for medicines should be introduced, so as to protect consumers, so how was the opposition blaming the EU for the introduction of the system?

It would be a shame if the opposition still believed that what was good for foreigners was not good for the Maltese.

Despite the declarations made during the debate, that the provisions of this bill would lead to an increase in the cost of medicines, no one had asked why medicines here cost more than in other countries.

The reason was that other countries with a population running into millions imported 5,000 to 7,000 different types of medicines, while Malta imported around 10,000 types.

This led to the country having a lot of the same sort of medicine from different sources. This could be due to a lack of control in ensuring that the medicines being imported were of the highest possible level.

Opposition MPs had asked why medicines registered in the EU would also need to be registered here, given the costs. The minister said the market authorisation fee would not be paid by the importer but by the manufacturer, and since medicines were sold all over Europe, this fee would therefore be split over 500 million customers. Medicines that were on the Maltese market up to last November would not be charged the full registration fee, despite the opposition's scaremongering.

Dr Deguara said it was not true that adoption of the euro would lead to an increase in the price of medicines.

Dr Deguara said it would be the cheaper medicines which would benefit most from registration since consumers would now be safe in the knowledge that those medicines were good for the purpose they were intended.

The minister referred to a press conference by the Chamber of Pharmacists and reiterated a promise he made at the beginning of the debate that in the committee stage of the debate, all doubts on the interpretation of each clause would be ironed out.

He insisted that talks held with the chamber on the licensing of pharmacies were part of a wider package, and since no agreement had been reached on the package yet, the agreement could not come into force. This was acknowledged by the chamber itself.

The chamber, he said, was under pressure from opposing fronts. On the one hand, there were some 300 pending applications for the opening of pharmacies, while those who already had a pharmacy did not wish to see new ones opening.

He could give an assurance that new licences for the opening of pharmacies would be issued, but the criteria of area population and distance from other pharmacies would be observed.

The bill was given a second reading after a division, with 33 in favour and 20 against.