The Pharmaceutical Journal
Vol 276 No 7406 p763
24 June 2006

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Association of the European Self-Medication Industry

All medicines can be switched to OTC status using centralised procedures

All prescription medicines are eligible for reclassification as over-the-counter medicines under the European centralised licensing procedure if it can be shown to be in the interests of patients.

Thomas Lönngren, executive director of the European Medicines Agency, said that guidelines on the optional scope of the centralised licensing procedure were being prepared, and it was in this area that the interests of patients fell. The guideline was expected to say that decisions would be made on a case-by-case basis, rather then list circumstances under which reclassification might take place. This meant that all reclassification applications would be considered, with none being rejected automatically.

Any successful applications would be granted a year’s data exclusivity [this means that no-one else can market the same active ingredient as an OTC medicine without making a full separate application].

Mr Lönngren said that reclassified products would be expected to have the same name EU-wide and that further naming requirements were to be announced in September. An example of the sort of difficulty with names that could arise was the UK product Zocor Heart Pro (simvastatin). Zocor could be used as a name in all countries, but “heart” was an English word that meant nothing in Greek and translating it into Greek would mean that the product had more than one name.

Anders Olauson, president of the European Patients’ Forum, said that a European guideline was also needed on the minimum information needs of patients.

He said that patient groups trusted the quality of the research that pharmaceutical companies carry out and they trusted the quality of their products. But they did not trust companies’ marketing divisions and the information they produced. Also, not all patients were capable of interpreting information sensibly. He said that this was proved by the fact that people continue to smoke despite the known risks.

Frits Lekkerkerker, chairman of the Netherlands’ Medicines Evaluation Board, said that a Europe-wide pharmacy-only category was needed for medicines that did not need prescription control, but which could not be sold without any restrictions at all. A pharmacy category was being introduced in the Netherlands and all new non-prescription medicines would only be available from pharmacies unless they were completely free of safety concerns and could be taken safely without any advice or professional supervision.

Slow countries must not dictate the pace

Centralised procedures should not be allowed to hinder progress in countries that want to make medicines available over the counter, the meeting was told.

“If the EU system can deliver, then great,” said Jeremy Mean, Medicines and Healthcare products Regulatory Agency group manager of information for public health. But, if it did not, then radical thinking was called for so that not all countries had to move at the rate of the slowest.

Tamiflu (oseltamivir), Xenical (orlistat) and Viagra (sildenafil) could all usefully be switched centrally, he said. Solutions were more important than problems. If a general public health benefit could be gained, then ways had to be found of reducing the risks of using specific products without medical supervision.

European rules retard progress

Europe’s regulatory framework for over-the-counter medicines compares unfavourably with that of the United States and hinders their development. This was the message from a number of speakers from the OTC medicines industry.

Kurt Soland, European head of Bayer Consumer Care, said that the separate systems of European Union countries, coupled with local ways of treating conditions and locally favoured ingredients, hindered development.

“True mutual recognition will allow a single reclassification submission and national authorities should not look for reasons not to accept somebody else’s decision,” Mr Soland said. “We should all accept an adequate standard and not seek a gold standard,” he added.

Criticising the operation of European licensing rules, he added: “All we have done is added an international layer on top of local rules … the US has 52 states, but one regulatory system.”

For Novartis Consumer Health, George de Vos said that European and national rules on trade names also got in the way.

“The rules for trade names are too complicated to be able to create brands,” he said. Manufacturer’s that wanted a prescription medicine reclassified for OTC sale were forced to change the name or lose reimbursement status for their products under some national health systems. But the European Medicines Agency view was that the no active ingredient could have two different brand names.

Chairman of the World Self-Medication Industry Hans Regenauer said that the biggest obstacle to effective self-medication in Europe lay in implementing the rules that were already in place.

“We just have to decide that we want a single Europe,” he stated. The problem was demonstrated by a product that was generally accepted as suitable for self-medication but had been blocked by one country that had deemed one of its excipents (1.5mg of magnesium stearate) to pose a serious risk to public health.

But a counter view was expressed by one Austrian participant who said that there were good reasons for the obstacles. Indicating that not everyone was capable of self-medicating safely, he said: “There are people who just don’t read labels.”