Malta is something of a pharmaceutical hub, with a thriving industry limited only by supply of skilled human resources and a respected and much-sought after Medicines Authority with a reputation for integrity and competence.
This Authority’s role goes beyond simple oversight, as the way the pharmaceutical market works means that it must act as a market player within the EU regulatory environment.
WhosWho.mt sat down with Professor Anthony Serracino Inglott, chairperson of the Medicines Authority, to see how this works, and why Malta is a respected player in the field.
“For a company to put a pharmaceutical product on the market, it must obtain market authorisation,” he says. “This is primarily obtained in two ways, both of which provide important competitive space for the local Authority to make its mark.”
One way, he explains, is to apply to the European Medicines Authority (EMA), to obtain a recommendation on whether the drug satisfies conditions of quality, safety and efficacy in order to be granted a license to sell the medicine in all EU countries.
Known as the “Centralised Procedure”, this sees national agencies (like Malta’s Medicines Authority) submit bids to the EMA to conduct the work.
The Medicines Authority is one of the top bidders in a process that is not awarded based on price – the price is set by the EMA. Bidders instead compete by competence and expertise, and on how strictly they stick to timelines.
“Our competence is strong – we have over 20 people with a doctorate, and nearly all our staff have a Master’s degree,” says Mr Serracino Inglott. “And Malta is one of the top agencies as regards respect for timelines.”
Timelines are very important as companies can have millions in daily sales – so going past the deadline by a few days can result in millions in lost sales.
Such delays may make companies complain to the EMA, which awarded the contract.
“So we need to be very stringent about this,” says the Medicines Authority chief. “Our employees have no schedule. They might need to work 12 hour days to meet their deadlines, they might need to work seven days in a week if that is what is needed to complete the procedure.”
“And we don’t ask them to do this,” he add. “They do this because it comes with the role, because they understand the importance of their work.”
Brexit has had a positive effect, as one of the strongest bidders was the UK. “Now the UK is not there, so we have a strong competitor out,” explains Mr Serracino Inglott, “and so we are now winning more of these contracts.”
The second way to obtain market authorisation is through a Reference Member State, where a company finds a state to take care of its product’s registration.
“We therefore need to entice these companies to choose Malta, and we do this by competing with other countries on a number of factors.”
In this procedure, price is one such factor – but not the only one.
Mr Serracino Inglott refers to Portugal as an example of a state with a price one tenth that of the Maltese Authority’s.
“Portugal does not work on a sustainabiity model like we do,” he says. “They are given a massive state subsidy to do their work, so they can offer unbeatable prices.”
“However, the Government then makes money by charging an export tax. So it provides the regulatory service almost free of charge, but then the more medicines you export, the more tax you pay.”
Malta’s system is the opposite. “We want companies to export more,” says the Medicines Authority chief. “So whether you export a million euros or ten millon euros’ worth, the fee is the same.”
Malta’s Medicines Authority thus attracts companies through its competence and integrity – “by giving them excellent service, answering the phone, sending them questions early on in the process to give them time to reply, contacting them to remind them if they don’t.”
“We keep a personal touch,” notes Mr Serracino Inglott with pride, “while strictly maintaining our integrity.”
That integrity is very important, because companies do not want to go to places which are not very strict in their process.
“They want to say ‘We’re registered in Malta because that’s one of the most competent authorities’. That’s what they say at the moment.”
“We have big companies that send us all their products,” he says. “In fact, we have more coming from large companies than smaller companies – because they afford us.”
“Others go to cheaper places, but then they have to deal with delays and other setbacks. While we work on strictly business patterns, instead of a bureaucratic manner.”