Medicine firms seek cure for Double Dutch

Even when there were just 15 member states, Brussels bureaucracy meant that the search to find an inoffensive name added three years and 500,000 to the cost of bringing a drug to market.

But Europe’s pharmaceutical industry is warning that EU enlargement will make the process almost impossible, and is demanding that the current rules are scrapped in favour of a naming free-for-all.

Rules on the new names for medicines are laid down by the European Medicines Agency, (EMEA), which approves drugs on behalf of the European Commission. They include restrictions on names which are too similar to drugs already on the market, names which imply overinflated claims for drugs, and those which might be offensive in one language or another.

In the past, drugs ranging from treatments for osteoporosis to irritable bowel syndrome have suffered delays as bureaucrats struggled to find an acceptable name.

But while the system creaked along while there were 12 official languages and 15 member states, EU expansion with addition of more countries, now threatens a crisis.

The European Federation of Pharmaceuticals Industries and Associations (EFPIA) warns that the needs of 20 official languages in 25 member states could push the system to breaking point as officials try to avoid offending speakers of Estonian, Latvian, Hungarian, and Maltese, to name but a few languages.

A spokesman for the EFPIA said: "So far patients have not been deprived of rapid access to new medicines because of this difficulty, because pharmaceutical companies strive and manage by all means to avoid such delays.

"However, as difficulties are increasing this danger is threatening, and we mostly fear the damaging effect of EU enlargement on the current situation."

He claimed that the authorities should relax their rule on having the same name for all the EU nations and allow different names to be used in various countries.

He said: "Agreeing on something that is meaningful and which does not create confusion in 20 languages is unworkable. We need clarity for the grant of exemptions and variations to the single trade mark requirement in ‘exceptional cases’, and we propose to set up an appeals procedure."

One senior industry insider admitted: "It does sometimes seem that almost as much time and effort goes into the name as goes into the medicine.

"We have so far avoided the situation where drugs cannot get on to the market because of naming problems, but that risk is there and is increasing. We already have speakers of the main languages, but checking for Estonian, Latvian and Hungarian swear-words is getting to be impossible."

In June 2000, the pharmaceuticals company Lilly asked Europe for approval for the name Forteo for a new osteoporosis drug. The EMEA ruled that the ‘fort’ part of the name was too similar to the French and Italian words for ‘strong’, ‘fort’ and ‘forte’.

They decided this made the drug sound like a super-strength medicine and told the company to find another name. Six months later it submitted an alternative, Forsteo, which was given the all-clear in June 2001, 18 months after the original application had gone in.

Another company was stopped from using the name Atrelar for a drug because the word was the same as the Portuguese for ‘leash’ and sounded potentially ridiculous to doctors in that country.

Last year, the Swiss-based company Novartis was refused permission to market its new treatment for irritable bowel syndrome under the name Zelmac, which was considered to be too similar to a scientific name. The drug was marketed as Zelnorm instead.

The popular range of cough, cold and throat medicines, Vicks, is known as Wicks in German-speaking countries because Germans pronounce a ‘V’ as an ‘F’. The resulting word has the same meaning in German as the f-word in English.

But because the medicines were marketed with the various names in both the UK and German-speaking countries before the EU rules came into force, the makers were allowed to continue with the alternatives.

The current EMEA rules allow a potential drug name to be vetoed even if the problem is caused by an official European language from a country the makers have no intention of selling to.

In order to minimise delays, many firms employ their own teams of linguists to check possible names and spot potential problems before EMEA get involved.

Meanwhile, manufacturers of other products, such as food, cosmetics, and cars, are allowed to opt for different names for various markets.

A spokesman for the European Medicines Agency, said: "It is in the interests of doctors and patients to have the same name for drugs across the European Union. It means that if you are unwell in another European country and looking for a medicine you know from home, you can get it or know what you are being given. We give guidance to companies to help them comply with the rules."