A law that will grant the Prime Minister powers to reassign the recently set-up Medicines Authority and its powers to the Malta Standards Authority (MSA) has spread concern across the pharmaceutical industry over the autonomy of the authority which licences its products.
Competitiveness Minister Censu Galea yesterday said he will be meeting members of the Federation of Industry (FOI) over concerns that the autonomy of the medicines authority – which licences medicinal imports and products for their safety – may be jeopardised.
The law, which is still being discussed in parliament, is meant to rationalise all activities of standardisation under the umbrella of the MSA, in a bid to render the set-up more cost-effective.
But industry observers have raised questions about the medicine authority’s role in ensuring the safety of medicinal products.
The FOI’s director-general Ray Muscat said 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.
“As far as we are informed, if the powers of the authority are passed to the MSA, this will only be in terms of management, rather than the licensing aspect. But the perception of such a move could prove to be worrying, especially in terms of foreign direct investment,” Muscat said.
Although the MSA council – which includes industry members from the FOI, the Chamber of Commerce, and the Chamber of SMEs (GRTU) – has no role in its directorates, Muscat said it is plausible that the directorates can be influenced by the budgets allocated to them by the council.
Industry sources speaking to MaltaToday expressed scepticism over the aims of the bill, fearing it would curtail the Medicines Authority’s power to licence medicinal imports – a bone of contention for importers who resented the hefty licensing fees and documentation required for importing medicinal products.
A quick glance across the spectrum of European authorities revealed that Malta would be the only EU member state, if the bill had to pass, where the regulator for medicines would be constituted by a governing council made up of representatives of the pharmaceutical industry, and medicinal importers – stakeholders who themselves have to be regulated.
“Ideally we want the authority to remain as it is,” FOI director Ray Muscat said. “If government goes ahead, we want those concerns about perception to be addressed. We don’t wish the industry to be upset.”