Published in the October 20 issue of the BMJ, the report, How can we regulate medicines better?, attacks the European Medicines Agency (EMEA) and suggests drug approval is flippant.

"Too many drugs are approved on the basis of surrogate end points that are not valid predictors of therapeutic end points," report authors Silvio Garattini and Vittorio Bertele said.

"New drugs have only to show they are of good quality, effective, and safe, independently of any reference or comparison to drugs already on the market . . . It is easier to get to the market by proving a new product is similar to standard available treatments than by failing to show it is superior."

Currently, the EMEA gives opinions on the quality, safety and efficacy of new drugs seeking approval. This opinion is used by the European Commission to decide whether to grant a license.

The two authors, from the Mario Negri Institute for Pharmacological Research in Italy, suggested new drugs should be required to have added value to already available treatments such as greater efficacy or less toxicity, or be cheaper.

"The FDA (US Food and Drug Administration) is apparently changing its mind on the suitability of non-inferiority trials, and we hope the EMEA will follow the same path."

The report suggested that to overcome this issue, an element of independent research should be done by non-profit organisations.

"For example, the regulatory agency could require one Phase III trial (usually two pivotal trials are needed) to be planned are carried out by an independent organisation credited by the agency, particularly for drugs that are going to be reimbursed by national health services."

At present independent research occurs only after approval.

The report also attacked the EMEA for its lack of transparency - "there is no reason to hide data on toxicology and clinical evaluation" which is "essential to understand why a new drug has been approved or a new indication granted".

Other information the report suggested should be made transparent included the size of the majority that approved a given drug, the reasons of the minority for opposing approval, conflicts of interest, and post-marketing commitments and their fulfilment.

The European drug system's weakness in pharmocovigilance was also highlighted.

"It relies on national activities, which in several cases are limited to spontaneous reports from patients and doctors. Clearly, collection of data about drug toxicity could be strengthened by establishing a net work covering all 25 European countries, coordinated by the EMEA," the report said.

The authors suggested companies should be obliged to present meta-analyses of beneficial and adverse events to the EMEA in their regular safety update reports, meanwhile, a new pharmacovigilance committee should be established which is separate from the Committee for Human Medicinal Products.

The report finally claimed the regulatory system was "subject to bias and suspicion", particularly as the EMEA is part of the EU general directorate of enterprise and industry rather than the general directorate of health and consumers.

The authors concluded: "Some of our suggestions will make the approval of new drugs and new indications more difficult and prolong the time needed for their introduction into the market. We may therefore need to be more flexible to encourage industrial research.

"One possibility would be to prolong product patents in exchange for better, safer, more trustworthy, and more affordable innovation. We believe the changes will not only be important for patients but will help stimulate innovative research by drug companies."

The EMEA declined to comment and the European Commission was unavailable for comment at time of publishing.