Concern at outsourced clinical trials in developing world

Drug research
Image caption The report found an increasing trend to outsource clinical trials

Few drug companies have robust measures to ensure outsourced clinical trials in developing countries are safe and ethical, an independent report says.

Most provided no evidence of exerting real influence over the way the trials were conducted by contractors, the latest Access to Medicine Index said.

However, the report also praised firms for stepping up their efforts to provide affordable medicines.

Published every two years, it ranks the world's 20 biggest drug companies.

GlaxoSmithKline remains at the top of the index, followed closely by Johnson & Johnson and Sanofi. AstraZeneca slipped down the rankings most significantly.

This is the third report by the Netherlands-based index, which is funded by organisations including the Bill and Melinda Gates Foundation and the UK's Department for International Development.

It is estimated that one billion people around the world are unable to afford the medicines they need.

The index report says that the drive to improve access "has landed in more boardrooms", with companies discounting products by as much as 50-60% - although sometimes it was difficult to ascertain the true baseline price.

But it urges all the firms to be more transparent about their lobbying practices.

Patients at risk

One of the authors, David Sampson, said: "Even though we raised the bar on our measures this year, and the economic climate has been difficult in the last few years, all of the companies have improved their approach and initiatives on access.

"Boards are taking control of this issue - and what they care about gets managed, measured and motivated in a way that flows through the organisation.

"There's an increasing trend to outsource clinical trials - but as is always the case with outsourcing, the relationship between the two parties needs to be extremely tightly defined and managed carefully.

"While most companies talk about codes of conduct and audit, only four companies disclosed details of disciplinary action that had taken place when conduct had fallen short.

"Regulatory regimes in developing countries are more variable - and anything putting patients at risk is an unacceptable practice and a significant concern."

The report was disputed by the Association of Clinical Research Organisations (ACRO), whose members conduct more than 11,000 clinical trials in 115 countries involving more than two million research participants each year.

A spokesman said: "Clinical Research Organisations actually face more exposure if there is a problem with a trial because poor performance can be a death knell for them, because the primary business is research. In this business, reputation is everything."

The index also examined what pharmaceutical products were being developed. Drugs to tackle the big killer diseases such as respiratory and diarrhoeal infections, Aids and malaria continued to be the primary focus - but more attention was being paid to some of the neglected tropical diseases.

More companies were found to be running "tiered pricing" schemes, in which medicines are cheaper for targeted countries or populations. The report authors said these should be expanded.

One example was the varying prices charged by Bayer in 11 sub-Saharan African countries, to help increase access to its contraceptive pill.

GlaxoSmithKline was praised for making its entire vaccine portfolio available to developing countries at an equitable price, though the index said it should reveal more about its marketing and promotional programmes.

AstraZeneca dropped from seventh to 16th place in the index "largely due to the fact that it has not made many advances in its access to medicine approach" since the previous report.

The company said the latest report was only one of several measures that provide an insight into medicine access and did not take full account of AstraZeneca's significant activities that promote better access to healthcare.

"Our core therapeutic focus is in chronic illnesses, which are responsible for an increasingly larger share of the disease burden in developing countries but are only partially considered by the Index," said a spokeswoman.

GSK chief executive Sir Andrew Witty said: "Enabling greater access to medicines is firmly at the heart of our business."

He said GSK's ranking was recognition of this, but added: "We recognise there is more we can do, and we will continue to challenge ourselves to adopt and deliver new ideas and approaches to improve lives around the world."

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