The Malta Economic Update's second Vodafone Economic Forum was held on 3 May 2006 at the Radisson St Julians, and was titled "Availability and accessibility of medicines: at what price?"
Pharmaceutical importers, manufacturers and representatives of the authorities discussed the issues after lunch. Moderated by Dr Maria Cordina, President of the Malta College of Pharmacy Practice, the Hon Louis Deguara, Minister of Health, the Hon Michael Farrugia, Opposition Spokeperson on Health, the Hon Censu Galea, Minister for Competitiveness and the Hon Joseph Sammut, Opposition Spokesperson for Commerce outlined their positions to the participants.
The discussion on the subject was animated, led by Mario Debono, heading the GRTU's Pharmaceutical Section, Joanna Cremona, Chairperson of the Chamber of Commerce's Health Trade Section, and Joanna Drake, head of the European Commission Representative Office in Malta.
Regulations require any medicine sold in Malta to be registered and to be issued an MA (marketing authorization) number by 1 January 2007. Strictly speaking, medicinals without an MA number will have to be taken off the shelves on that date. There is a proviso: medicinals which have applied for but not yet received their MA number by the middle of 2006 will have a further six months to get into line.
This requirement has a very worthwhile intention. It will be a further measure to guarantee the quality of medicinal products Maltese patients use. The application process requires considerable documentation to be supplied to the MMM, aimed at establishing that the medicine is safe, and at documenting the supply chain, manufacturing processes and distribution channels.
Quality
The approach has a lot in common with the quality of service standards being applied in other industries in its insistence on documentation. With medicinals, however, the details required are much more detailed, as is to be expected.
As an approach, it does create problems, especially in a small market like Malta. Registration carries substantial direct and indirect costs. A fee is charged for each new registration. Every slight change has to be notified to the Authority; each change or variation registered is also charged a fee. These changes can be as minor as the change of a word on the patient information leaflet, and there can be many of these over the course of a single year.
Getting the documentation together and up to standard also takes a lot of time and work. At least one pharmaceutical import company says it employs two people solely on compliance issues.
Dr Louis Deguara told the forum that his Ministry has information that the cost of registration is covered by the pharmaceutical principal, and that therefore the impact on the price of medicinals was expected to be minimal. However, a number of participants pointed out that while this is the case in larger markets, in Malta the situation is different.
Profitability
The pharmaceutical companies look at the profitability of each market, the forum was told. The cost of registration in a small market like Malta's can be greater than the profits generated by the product. In this case, one course of action open to the principal is to withdraw from the market, an option already taken in a number of instances.
The costs of maintaining the registration eat further into potential profits. One agent told the forum he was expecting to pay Lm10,000 on registering variations over a one year period. Another importer said his registration and compliance costs are some Lm17,000 annually - on a turnover of Lm200,000. This is 8.5% of turnover. This cost will inevitably filter through to the price of the medicine.
Furthermore, regulations require the patient information leaflet to be printed in both English and Maltese. There is a relaxation allowing the Maltese language insert to be placed on the internet for download rather than included in the package, the Hon Louis Deguara told the Forum. But, as Joanna Cremona and other participants pointed out, the problem here is with the translation itself: first, are there translators capable of handling the sometimes very technical language involved; and secondly, are there translators willing to take responsibility for such a subtle piece of text?
Language
The language issue raised a lot of comment. A number of participants said that
All this has created a real risk that on 1 January 2007, a lot of medicines we have come to rely on will have to be withdrawn from the market. The build up of costs has serious implications for both the availability and the affordability of medicines.
Mario Debono opened the discussion after lunch telling the Forum that the situation with registration of medicines is "going from bad to worse." He complained about what he called a "lack of communication and understanding", saying that Malta - with a market of only 400,000 - is saddled with a registration system suitable to a large country. He said the process needs to be speeded up.
"We need to go beyond our country, to the EU, to find a solution that fits our small island state," he said. "We need the government and the opposition to work together to solve this."
The Chamber of Commerce's Joanna Cremona detailed the four main problems pharmaceutical importers have found with the registration system as it stands today. Compiling the dossiers required for registration is a very labour intensive process, she said. Worse, the full documentation may not be available for the older drugs on the market. Secondly, registering variations carries a high cost and also requires a lot of labour.
Interpretation
"Importers will need to put the MA number on the packages. With some companies, this will be no problem - but it will cost eight or nine cents per pack!" she added. Translation of the patient information leaflet into Maltese will also prove a problem.
What became clear from the forum was that there is a potential crisis brewing. It is one that needs to be worked on fast, with full support from all interested parties, the Government and the Opposition. It remains important to avoid introducing new and larger government induced costs on businesses. If the pharmaceutical manufacturers find themselves unable to supply Malta with the medicines it needs, then no one benefits.
The EU rules may not be open to renegotiation or revision, but they should be open to reinterpretation and re-implementation. For this to be successful, it requires the government and the opposition to work hand in hand. This is what the forum participants were asking of their elected representatives.
The Malta Economic Update thanks Vodafone Malta, HSBC Malta, Progress Press, Radisson St Julians, Actavis, Bad Boy Cleaners and PKF for their invaluable support.
Event Images
Censu Galea considers a point, sitting next to Louis Deguara |
Ray Busuttil
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The CMTU's Mario Dedono
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Joanna Cremona, of the Chamber of Commerce
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Maria Cordina moderated the forum
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The panel: Censu Galea, Louis Deguara, Maria Cordina, Michael Farrugia and Joseph Sammut
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