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Swiss demand more drugs transparency

The side effects could be hazardous to pharmaceutical firms Keystone

Swiss consumers are calling on drugs companies to come clean about medications that have not been approved for use.

Switzerland’s main consumers’ association wants the Swiss to have the same rights as their European neighbours.

In December the European Union passed a new law to improve transparency in the European Agency for the Evaluation of Medicinal Products (EMEA) – the body responsible for drugs licensing in Europe.

The law calls for the publication of all decisions taken by the EMEA, including where it has withheld licences for certain drugs.

“In the consumers’ interest we would welcome it if an independent body published the test results,” the director of the consumers’ association, Jacqueline Bachmann, told swissinfo.

The new EU law means the Swiss pharmaceutical industry will have to rethink its strategy, as non-compliance could affect its exports – two thirds of Switzerland’s drugs are exported to the EU.

The new drugs law also calls for the EMEA to publish all non-confidential documents and to inform the public if scientists disagree over whether a drug should be approved or not.

Drug rejection

So far it has been up to the pharmaceutical company concerned to decide when and how it wants to inform the public about the approval or non-approval of a new drug.

Interpharma, an organisation of Swiss pharmaceutical research companies, is not too worried about the new EU law.

“We are not against transparency – it actually already exists today,” said Interpharma spokesman, Thomas Cueni.

Cueni referred to the current practice of companies reporting on the state of their research projects and drug licensing procedures.

However, the ruling has met with some resistance from the European pharmaceutical industry. Revealing that a drug has been denied approval could have serious consequences for a company, denting its image and affecting its performance on the stock market.

“Communicating information about drugs is a special business, and we have to be extremely careful,” said Cueni.

Under pressure from the European Federation of Pharmaceutical Industries and Associations (EFPIA), the EU agreed that the final decision of the EMEA can only be published after a period of 15 days.

Appeal

In the event of a company appealing against the EMEA’s decision, the verdict cannot be published until the case has been resolved.

In Switzerland only the company applying for a licence is informed about the decision taken by the Swiss Agency for Therapeutic Products, Swissmedic. It is then up to the applicant to decide whether to tell the public or not.

Once approved in Switzerland, most of the drugs are also accepted in the EU, and as the approval procedure for new medicines is faster in Switzerland, the country also acts as a testing ground for its European neighbours.

“Once a medication has been approved in Switzerland it will take another two to three months before it is commercialised in the EU,” said Cueni. “It hardly ever happens that the EMEA takes a different decision from Swissmedic.”

Parallel imports

The ban on parallel imports also protects Switzerland’s pharmaceutical industry. Although drugs prices are higher than in most other countries, imports of cheaper versions from another country are not allowed.

In the EU a drug can be traded freely once it has been licensed within the union. Distributors there can take advantage of the price differences in the 15 member states and buy drugs in a cheaper country to sell on at a higher price in an expensive country.

“The parallel import of drugs is a legal way of trade in a single market and it is in the interest of the patient,” the EU commissioner, Frits Bolkestein, said earlier this month.

“If this applied to Switzerland our prices would drop significantly,” commented Jacqueline Bachmann.

swissinfo, Katrin Holenstein

In 2002 Switzerland’s three biggest pharmaceutical companies, Novartis, Roche and Serono achieved a global turnover of $30 million (SFr38 million). This is a market share of 7.5%.

The global market is estimated at $400 million (SFr500 million).

More than 90% of Switzerland’s drugs production is exported – 66% to the EU, 12% to Asia and the United States.

86% of imported drugs come from the EU.

Drugs prices in Switzerland are amongst the highest in Europe.

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