New EU clinical trials regulation is passed
The European Parliament has backed a draft law that will force pharmaceutical companies to post the results of clinical trials that have been carried out across the continent.
Proposals have already been informally approved by European leaders, with a recent vote underlining the popularity of the legislation. MEP Glenis Willmott brought the policy to Parliament and her report revealed that 594 people voted in favour of the law, while just 17 were against it. It seems inevitable that these reforms will be made in the near future and pharmaceutical companies will need to adapt in order to comply with the new regulations.
What is the purpose of the proposed law?
Quality research is fundamental to the provision of healthcare services and treatments and some organisations felt the original EU Clinical Trials Directive - which was introduced in 2004 - was too restrictive.
Figures published by the UK's NHS Confederation's European Office showed the number of clinical trials being conducted throughout Europe has fallen by 25 per cent since the regulatory framework was rolled out and costs have also risen sharply. Director of the organisation Elisabetta Zanon said the legislation placed a "huge bureaucratic burden" on healthcare providers within the EU.
The European Commission has now proposed an overhaul of the existing system, with companies being forced to publish clinical trials data in a publicly-accessible EU database. It hopes this will increase transparency and will also enable greater cross-border collaboration on medical trials.
Ms Willmott said the move could open up a number of highly-skilled research jobs across the continent and will make Europe an attractive destination for companies to complete trials.
"Over the last few years Europe has been losing jobs in research as clinical trials move elsewhere in the world. By streamlining the rules, whilst keeping patient safety at heart, we can be more competitive, create new jobs and ensure that Europe remains a world leader in medical research," she commented.
"The new law will also offer hope to the millions of people in Europe suffering from rare diseases, by making cross-border trials much easier to conduct. There are simply not enough patients in one country alone to develop new or improved treatments for rare diseases. By working at EU level we can reduce the huge cost and burden of conducting trials across borders."
EU leaders have confirmed that companies that fail to comply with these laws will be fined, so it is vital that pharmaceutical corporations and research organisations adapt their way of working as soon as the new law is enforced.
Companies hit with R&D funding issues
Businesses are finding it increasingly difficult to fund the research and development (R&D) of drugs, as costs have risen sharply in recent years. Since the global economic downturn, pharmaceutical corporations have been wary about pouring money into clinical trials because success rates are still low. For every drug or treatment that becomes fully commercialised, there are many more that never leave the laboratory.
Companies are particularly reluctant to fund the R&D of medicines that are unlikely to make a substantial profit - even if they have the potential to save thousands of lives. Pharmaceutical professionals will hope the impending EU reforms on clinical trials will ease some of the strain that expensive R&D drives are placing on their organisations.
Greater collaboration is required in the drug making industry and this has led to a significant upturn in the number of joint ventures being launched throughout Europe and beyond. This enables firms to share expertise, technology and other resources with companies in other parts of the world. While the benefits of this approach are clear, businesses must learn to adapt to different working methods if they are to make progress alongside rival organisations.
The pharmaceutical industry has evolved quickly in the past few years and further changes are inevitable in the near future thanks to legislative changes, increased merger and acquisition activity, rising costs and investor unpredictability.