Drugs giants push to get out of fix over product names

By Peter Chapman

Date: 09/09/04

DRUGS giants are lobbying the European Commission to loosen the system for approving the brand names they give to their new medicines.

The industry spends millions of euro and months developing snappy names such as Viagra, Prozac and Feminax.

But firms complain that around one third of their ideas are rejected by a committee at the European Agency for the Evaluation of Medicinal Products (EMEA) - the body that carries out the drugs approval process on behalf of the Commission.

The committee responsible for names vets would-be brands to make sure they would not confuse doctors and patients, for example by sounding similar to another drug, or looking the same when written - a problem, given the notorious illegibility of doctors' handwriting.

They are also checked to make sure that they do not cause offence.

Mats Pårup, head of global trademarks for pharmaceuticals at Novartis, said that even more rejections are likely to occur because of EU enlargement.

The influx of new languages increases the chances that a drug name acceptable to most countries would mean something unprintable in Latvian or Czech.

Pårup, who heads a group on the issue at the European Federation of Pharmaceuticals Industries and Associations, said companies were often given no explanation why their ideas had been rejected - and had little chance to change the committee's mind. He said firms would air their views at a meeting with the EMEA committee - whose members also include officials from member states and the Commission - next week (13 September).

Industry sources say the costs involved in whittling down a brand name from several hundred ideas to a final choice can amount to €750,000 per drug.

Risk management systems are in place to ensure that companies road test their ideas before submitting them for approval. They also have second and third choices lined up and delays need not occur getting a product on the market.

But rejection of a name can mean that any money spent on pre-marketing is wasted.

Pårup said firms wanted to make the process more transparent and to have the right to alter troublesome names in the markets without having to scrap the brand all together.

But current EU rules make that difficult as firms are only allowed one name for their drugs in the European market.

A Commission official admitted that it is often difficult to select a suitable name that is appropriate in all the official languages of the EU. But he insisted that the committee is not free to ban names on a whim. "Invented names will be accepted unless there is a public health and/or safety risk," he said.

Moreover, drugs companies already have the information they need to avoid rejection of brand names since the committee has produced guidelines for applicants to explain the criteria used to assess the acceptability of names, he added.

Trends in drug names are changing with the times. In the 1970s and 1980s, there was a clamour for names beginning with the letter 'A'. The logic was that these drugs appeared at the top of the product directories used by doctors and were thus more likely to be prescribed.

Following this was a shift to the other end of the alphabet - with many products starting with Xs and Zs. Nowadays, firms are dabbling with references to the classics or making clever plays on words.

Pharmaceutical firms are pleading for less tight regulations on product names for new medicines. They argue that the rejection of a product name by the European Agency for the Evaluation of Medicinal Products (EMEA) involves high financial losses.

• Primary Source

European Medicines Agency: Homepage http://www.ema.europa.eu/

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