Labour makes clinical trials law a manifesto pledge
pharmafile | April 15, 2005 | News story | Research and Development |
The Labour party has promised to introduce new legislation which would oblige pharmaceutical companies to publish clinical trial data for all products marketed in the UK.
The plans were launched as part of the ruling party's general election manifesto and Labour say the new laws have been proposed in response to recommendations by the Health Select Committee.
Following a comprehensive review into the influence of the pharmaceutical industry, the committee of MPs concluded there was urgent need to distance the industry from the regulator the MHRA and make decisions on drug safety and efficacy more transparent.
Enforcing publication by law would actually go one step further than the Select Committee had demanded, but the government will hope its firm action on clinical trials will allay fears about the industry's influence and draw a line under a long-running controversy.
The ABPI introduced an online register of UK trials in 2003, but pharmaceutical companies were not obliged to add their details to the database, and it has suffered from poor uptake to date.
In January this year the global industry agreed to make all data relating to marketed products available online, following the lead set by GSK, Lilly and Forest Laboratories.
In this context, Labour's proposals to introduce laws will merely formalise a move to which the industry is already committed. It also seems unlikely that Labour will take any further action in response to the Health Select Committee's recommendations – a result which the pharma industry will consider a victory of sorts.
A spokesman for the ABPI said the proposed legislation was nevertheless unnecessary.
He said: "We recognise the need for clinical trial data to be in the public domain. I think what needs to be borne in mind is that ours is an international commitment because clinical trials is a global need which requires global participation.This goes further than a unilateral UK law."
He continued: "Our commitment should meet these requirements without the need for further direct legislation and bureaucracy and it will be in place before any UK legislation can be drawn up."
He said the ABPI and industry were awaiting the government's full response to the Select Committee recommendations, expected to be published after the election.
