New pharmaceutical rules may cause shortages

The new pharmaceutical registration regulations, which will come into force shortly, aim at ensuring the quality, safety and efficacy of medicines on the market but both the Chamber of Pharmacists and importers fear a shortage of certain medicines may ensue.

The regulations impose a Lm50 fee for the registration of pharmaceutical products coming from EU countries, with higher fees for those coming from beyond.

Because Malta is a small country, it is not excluded that certain products, which are used only by few people, will no longer be imported, Chamber of Pharmacists president Mary Ann Sant Fournier said.

Asked whether the cost of registration would affect the importation of medicines, Attard and Co. Ltd medical representative Matthew Gatt said this might be the case because certain products were not viable since Malta was a small market and the cost of registration was too high to make it profitable to keep such a product on the market. This would be detrimental to patients, he said.

Roberta Pace Balzan, from Pharmacos, said it was possible that a number of medicines would no longer be imported although, she was quick to add, this depended on various factors and not solely on the cost of registration.

In addition, she said, the health authorities could refuse a market authorisation for a product. She explained that documentation to prove the quality of medicines must be submitted and approved by the health authorities before the marketing authorisation was granted. She stressed that while different formulations (tablets, cream or ointment) and strengths of the same product must be registered separately with a fee paid for each one, different pack sizes of the same product were considered as one application, with one fee paid.

Ms Sant Fournier said there might also be an effect on the price of medicines, mostly because every dosage form and dosage have to be registered separately.

She said the implementation of new regulations were long overdue because society needed to be safeguarded.

"Medicines are not ordinary commercial items and that is why the EU has a number of regulations related to them," she said.

Ms Sant Fournier said the chamber has been lobbying for this legislation for two decades. She explained that through registration, there would be an audit trail from the raw material up to distribution of the medicine and to its being dispensed to the patient by the pharmacist.

She explained that the pharmacist had the trust of the patient, but the only guarantee that the pharmacist had was the knowledge of who the manufacturer and importer were. However, more assurances about the quality, efficacy and safety of medicines was needed.

She said that if certain medicines ceased to be imported, the patient needed to discuss with his/her doctor and pharmacist about possible alternatives. However, she stressed the importance of knowing what was going to happen so that patients could be informed accordingly when they requested or were prescribed a particular product.

Chamber secretary Max Borg Millo said that in certain countries people crossed borders to buy unavailable medicines but in Malta this was not an easy thing to do.

Although the chamber was all in favour of registration, Ms Sant Fournier said Malta should not reinvent the wheel and create draconian structures.

Mr Borg Millo said small EU-acceding countries have adopted smoother transition marketing authorisation procedures that Malta could have emulated.

Ms Sant Fournier feels Malta could have created a simple structure and applied existing resources.

Mr Borg Millo said that since November 2002 there has been no possibility of new products being imported into Malta. That was the cut-off point when the authorities decided to start an initial "provisional" marketing authorisation process on the medicines that were being sold locally - Malta's EU Derogation List of Pharmaceutical products. However, he said, this process was long drawn out while all the interested parties waited.

"Last January the authorities dumped the idea of an initial "provisional" marketing authorisation and decided to go for a fully-fledged marketing authorisation exercise instead, with another (already postponed) deadline to meet lengthy application-form completion," he said. The products coming from EU countries would be given priority.

Both chamber officials complained about the lack of consultation with regard to this issue.

Contacted by The Times, Patricia Vella Bonanno, from the Medicines Regulatory Unit, said the unit did not yet know whether certain medicines would no longer be imported because of the cost of registration. However, certain products might not be able to fulfil the application requirements.

Dr Vella Bonanno said that the registration process was intended to protect public health by ensuring the quality, safety and efficacy of products on the market.