The Chamber of Pharmacists has expressed “serious concerns” over a potential move to integrate Malta’s Medicines Authority into another body, the Malta Standards Authority (MSA) – as part of a governmental effort to achieve a more efficient bureaucratic set-up.
The Medicines Authority, one of a list of regulators which sprung out of EU legislation, is the first to face incorporation into another authority.
Critics claim its autonomy as the official medicines watchdog could be compromised because part of the Bill enables the Prime Minister to designate any authority to carry out the functions of the medicines authority, as part of government’s effort to rationalise the activities of authorities involved in the field of free movement of goods under the umbrella of the MSA.
The president of the Chamber of Pharmacists, Mary Anne Sant Fournier, has described the proposal as a “sword of Damocles hanging on the pharmacy profession and the whole pharmaceutical sector”.
“It introduces undesirable uncertainty in the highly specialised and socially essential regulation of the area of human medicines, together with its economic connotations, because of the export needs of the local pharmaceutical manufacturing sector,” Sant Fournier told MaltaToday.
Instead she called for a strengthening of the Authority’s autonomy and independence and for the introduction of more clear structures to ensure transparency and accountability with a more direct involvement of stakeholders. “Although one must do justice with the present CEO who is a professional who believes in dialogue when and wherever this is possible. This must be also said of her professional pharmacist staff,” Sant Fournier said.

Concerns
The apprehension over the proposal concerns both consumer safety and issues of credibility for Malta’s pharmaceutical industry.
Critics include the Federation of Industry (FOI), which represents pharmaceutical companies whose products are licensed by the Medicines Authority.
Both the Chamber of Pharmacists and the FOI sit on the MSA’s governing council, but the presence of various business organisations which represent other stakeholders such as medicines wholesalers on the council has prompted fears that the Medicines Authority’s autonomy could be compromised.
While Sant Fournier said the MSA directorates’ independence is guaranteed by robust legislation and its council, she added that this was not enough to ensure the integrity of the Medicines Authority if it is transformed into one of the MSA’s directorates.
“The (council) consists of government and stakeholders’ representation including this Chamber. This may be considered by some as an added guarantee to the functioning with regard to accountability and transparency, of a hypothetical MSA directorate of medicines. But in the Chamber’s opinion this is a shortsighted view.”
The Chamber is challenging the notion of treating medicines as ordinary items of commerce.
“The Medicines Authority is not only concerned with the registration of medicines, which is a significant feat in itself requiring by its very nature full autonomy – financial, administrative and professional. Indeed, the Medicines Authority regulates the activities of the whole pharmaceutical sector and pharmacy profession.”
She said that Malta’s medicines watchdog is responsible to ensure the highest possible standards for the medicines used by patients, by monitoring their manufacture, wholesale distribution and dispensation by pharmacists. It also restricts advertising and marketing practices, and ensures good practice standards across the entire board, including the pharmaceutical industry itself.
But at the heart of the Chamber’s concerns is the question of consumer safety.
“We are talking here of medicines and patients. The implementation of the EU directives relevant to human medicines have as an objective the assurance of quality, efficacy and safety of medicinal products moving in the internal market
“That the pharmaceutical legislation is very extensive and comprehensive is a moot point. If instead of ‘rationalising’ and treating human medicines under the context of ‘freedom of movement of goods’ one uses the maxim ‘medicines are not ordinary items of commerce’, then considerations with a different forma mentis would not be considered out of order,” Sant Fournier said.
“The registration of medicines is envisaged to ensure these standards for branded and generic medicines, as also for parallel imported medicines to safeguard the health of the patient. We strongly reiterate that the autonomy of the MMA is crucial in consideration of all of the above.”

Industry perceptions
There are also concerns over the perception of the Medicines Authority in its role as a regulator for pharmaceutical products manufactured in Malta. The FOI’s director-general Ray Muscat has in the past stated that autonomy was key to the pharmaceutical industry, which has exported over EUR26 million in products in 2005, and is composed of foreign investment in its entirety.
“It has taken quite some time to build a reputation of an industry that is regulated by an autonomous body, that is responsible to the health ministry and not to the ministry of industry. Perception counts in the pharmaceutical industry, especially the way the authority functions and how it is seen functioning from abroad… such a move could prove to be worrying, especially in terms of foreign direct investment,” Muscat said.
Sant Fournier chipped in saying that the Authority has developed into a credible institution, nationally and internationally, importantly at European Union level.
“This credibility has been attained through the professionalism and expertise of the pharmacists practising at the Medicines Authority. It has undoubtedly also been attained through the implementation of the Medicines Act as enacted. It is very important that this credibility has been attained, in view of the registration needs of Malta’s rapidly developing export-oriented pharmaceutical industry, which is such an important asset to our economy.”
The Chamber has already expressed its concerns to the Prime Minister, the Minister of Health under whom the Medicines Authority falls, and the Minister of Competitiveness, the latter being responsible for the MSA.
It also registered its concerns with the MSA council, following which a meeting was held with the chairman and CEO to address the matter. Sant Fournier said the Chamber is keeping informed all pharmacists who are directly involved in this matter.

Links: www.maltatoday.com.mt/midweek/2007/08/08/n2.html