Medicines being registered to protect the consumer

A medicines registration process which seeks to ensure the safety and efficacy of pharmaceutical products is in full swing, with a number of products having been provisionally registered to show they are of good enough quality to be sold on the market.

John Joseph Borg, post-licensing director at the Medicines Authority, explained that registration would protect the consumer. For example, some products which had been approved for a certain condition were marketed for other conditions for which no tests had been conducted and no approval given.

Sometimes, not all side effects or warnings were listed on patient leaflets. And there were instances when a product's literature stated it could be given to children even though no tests to prove this had been carried out.

"European Union legislation is there to protect the consumer," he said. "Through EU legislation, a product needs to be registered before it can be marketed in a country. This involves the presentation of the product's dossier - detailed literature showing that the product is safe and of good quality.

"Sometimes, even if a product was registered in other European countries, we used to get different packaging, targeted at certain other countries outside the European Union. At times the packaging and patient leaflet did not reflect the dossier," Dr Borg said.

These products will have to be removed from the local market by the end of next year and all the information supplied with a pharmaceutical product will have to reflect the product's dossier, which means that any information must be backed up by scientific studies. A transition list of around 7,000 products was compiled two years ago as part of Malta's negotiations to join the EU. The majority of these products - 5,500 - were European.

Medicines Authority pre-licensing director Helen Vella said that not all the pharmaceutical producers had shown an interest in applying for a full marketing authorisation in Malta. In fact, interest has only been shown with regard to 2,300 products. However, she added, medicines could also be placed on the market if they had a European authorisation or were mutually recognised with other countries, which meant this could lead to Malta having well over 2,300 registered products.

The registration process has led to some complaints by consumers that it may have led to a shortage of certain medicines.

Opposition health spokesman Michael Farrugia claimed in Parliament that since the market was small and registration costs were high, some companies had opted to discontinue the importation of certain medicines.

The situation has created problems for some patients. Chamber of Pharmacists president Mary Anne Sant Fournier and secretary Max Borg Millo said that when a product was no longer available it usually took some time to find a suitable alternative. It was not always easy for a patient to switch from one product to another, and Ms Sant Fournier said there were some medicines that were very specific.

She agreed that because of the size of the country, or excessive bureaucracy with drug dossiers, some manufacturers might not bother to register some medicines here.

However, she said, newly announced provisions provided for the registration process to be waived if a life-saving drug was invented or was needed, for example, at hospital.

The Medicines Authority representatives explained that when an innovator product was invented, the mother company, or any member state, could apply for this medicine to be administered to patients at an early date through registration on the basis of "compassionate use". This meant that a breakthrough product, for which no alternatives existed, could be used by a group of patients, even before this was ready for the market.

But Ms Sant Fournier said this could create a discriminatory position between "normally" registered and "emergency" registered products.

The chamber is insisting on the importance of a clear chain of communication to both doctors and pharmacists who should be informed when a certain medicine was no longer going to be brought to Malta. If this did not take place, the person to suffer would be the patient, who would be confused as to what was happening, Ms Sant Fournier said.

The process

A product can be registered in three different ways - centrally through the European Medicines' Agency (EMEA), nationally in a particular country or through the Mutual Recognition Procedure (MRP).

Dr Borg said the centralised route was usually used for very specific innovator medicines (including those for serious diseases like cancer and HIV), although the list of conditions was expected to increase.

Medicines Authority chief executive Patricia Vella Bonanno said that around 255 products had EMEA registration and these could be marketed in Malta as from May last year. However, the decision of whether to market a particular product in Malta rested with the pharmaceutical company that held that registration.

Through the MRP a product that is registered in one Extended European Community country can be registered in all the other countries through one registration procedure. However, most products are not being registered in this way since an MRP was carried out previously with the old 15 EU member states and it was not usually feasible for a company to initiate another procedure for just one country.

When a product which is not found in any other EU country is registered in Malta through the national procedure, it can also be registered in the rest of the Union through the MRP. However, Dr Vella Bonanno explained that acting as a reference country meant a lot of responsibility not only for the registration of the product and the initial assessment of the quality safety and efficacy, but also through its post-marketing authorisation lifespan.

She said that since Malta did not yet have the necessary expertise in all medicinal products (for rare diseases and technological breakthroughs), it was highly probable that if Malta had to be the reference member state, a big chunk of the assessment of the safety and efficacy would have to be subcontracted to another national competent authority.

"It is usually the bigger member states which act as reference countries" she said, adding that certain countries were synonymous with expertise in different fields. Hungary, she explained, had a certain expertise in biotechnology while Germany had a vast expertise in vaccines.

Patients can also bring in products that are not found in Malta, for their personal use after obtaining a doctor's prescription. More information can be accessed on www.health.gov.mt/mpau/circulars.htm

Once a product is approved, patient information leaflets will be available online on the Medicines Authority website. Dr Vella Bonanno said the intention was to empower the patient, who was nowadays looking for more available information about the product he is consuming. It is important to note that when a medicine is administered, both therapeutic benefits and side effects might result.