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Regulatory issues

Drugs regulatory bodies ought to be the public’s principal defence against medicines that are useless, unproven or downright dangerous. Yet regulators increasingly depend upon financing from the pharmaceutical industry itself.  

Sending the wrong signals

In early 2009, 60 mg capsules of orlistat, containing half the prescription dose were approved without a prescription. Once again, the authorities are sending a signal to drug manufacturers that they can continue to develop and market drugs offering little if any concrete therapeutic benefit.

Gambling with patients’ well-being

When drug regulatory agencies grant marketing authorisation on the basis of initial data, they are betting that subsequent trials will confirm these results. And if they do not demand follow-up studies or at least one confirmatory trial, they are gambling with the well-being of patients.

WHO is mandated at last to do essential biomedical research

A system in which biomedical research is funded by sales of patented products cannot be expected to meet all the healthcare requirements of people living in poor countries. World Health Organization member states finally adopted a resolution giving WHO a central role in research on diseases that "disproportionately affect developing countries".

Patients' interests first

In authorising rimonabant (Acomplia°) in 2006 despite its negative risk-benefit balance, the European authorities once again chose to put pharmaceutical company interests ahead of protecting patients. It took them two years to come to their senses. Instead putting patients’ interests first, from the beginning.

What companies want

There is cause for concern about patients and healthcare expenditures, if the so-called regulatory authorities allow the most influential pharmaceutical companies to get their way, as the French authorities’ behaviour in the case of pegaptinib (Macugen°) has demonstrated.

Vision

When it comes to pharmaceutical companies’ strategies, many policy makers suffer from short-sightedness. Policy makers who see the situation clearly and who care about improving the social welfare system will reject pharmaceutical companies’ "compliance" programmes.

Perseverance

New drugs are often introduced to the market while their clinical evaluation is still underway. Drug regulatory agencies and government organisations must work towards rigorous, long-term evaluation of new drugs: it’s a matter of public health, in the fullest sense of the word.

Demanding higher standards

There are ever more reasons to demand high-quality information concerning the latest new drugs coming onto the market. To spare patients from exposure to unjustified adverse effects. To force pharmaceutical companies and drug regulatory agencies to shape up. And to cut down on waste at public expense.

Premature marketing authorisation: danger

In recent years the approval process for new drugs has accelerated. This is a result of both strong pressure exerted by drug companies, and attempts by weak-kneed authorities to pander to the pharmaceutical industry and some members of the public seeking ever-earlier access to "innovation".

Hypocrisy

The European authorities have once again undermined their credibility by putting a drug company's financial interests before the health and safety of the citizens they are supposed to protect.

Post-market studies: broken promises

The right time for drug regulatory agencies to obtain information from manufacturers on a product is when they are examining the marketing application. Once approval has been granted, the balance of power shifts, allowing manufacturers to escape commitments or delay them to the detriment of patients.

Rare diseases: more new drugs, mixed results

Patients suffering from rare diseases are entitled to drugs that have been adequately evaluated, and that can give them concrete guarantees, not just hope.

Nutritional health warnings: just for show

In France most food adverts aimed at children are for products that have no nutritional value. The prevention of obesity requires unequivocal measures to limit, and possibly even to prohibit, advertisements for industrially manufactured food.

Risk management plans: far from reassuring

Drug risk management plans lack transparency and contain ambiguities.

Distinct and separate roles

At their core, all healthcare activities centre around the needs of individual patients who are seeking help to deal with a health problem. Any confusion between the roles of the different players in the healthcare system undermines not only overall quality of care, but also patients' freedom to base treatment choices on their individual needs.