Mills & Reeve Education Law Blog: Fusion

The new Clinical Trials Regulation - moves towards streamlining and transparency

Clinical trials for medicines in Europe are tightly regulated. The current system, introduced in 2001 under the Clinical Trials Directive, has been criticised for being too onerous and costly. The proposed new Clinical Trials Regulation is intended to cut red tape and make it easier for pharmaceutical companies to conduct multinational clinical trials.

Because the current rules were introduced by Directive, they had to be implemented by each country individually to become operational. Although a Directive sets out uniform rules, it allows some flexibility in how member states give effect to them. In contrast, a Regulation is an EU level instrument which takes effect without any need for national action and with no variability between countries.

A welcome introduction is the concept of ‘low-intervention clinical trials’. These will impose a lighter regulatory burden on trials which are seen as exposing subjects to lower risk; an example being the comparison of already approved medicines.

One area that has received much attention from policy-makers and the media is transparency. The new rules will make it compulsory to publish all clinical trials, including those that do not support use of the medicine.

The Regulation has recently been finalised, although it cannot take effect until the new EU Portal for central submission of data is up and running. This is expected to take until mid 2016.

Meanwhile, the European Medicines Agency is planning to move from reactive to proactive publication of clinical trials data.

The EMA is already releasing documents submitted as part of applications for EU marketing authorisations in response to requests. It claims to have made public nearly 2 million pages of data from November 2010 to April 2013 alone. The system allows for redaction to protect personal data or commercially sensitive information, although at least two companies have brought proceedings against the EMA for giving access to clinical data.

The EMA is now aiming for proactive publication of clinical trial data once the decision on whether to grant an EU marketing authorisation is made. A consultation launched last summer received a wide range of comments and the EMA has been refining its approach. The policy is due to be finalised in June this year.

Many pharma companies are now embracing transparency. Astra Zeneca's global policy is one example. A sensible approach now that it is becoming inevitable.

Isabel Teare, Professional Support Lawyer

Volunteers and protection from discrimination

A recent decision of the Supreme Court in X v Mid Sussex CAB has established that volunteers without a legally binding contract are not protected by either domestic or EU anti-discrimination law. In this case, it was alleged that a volunteer had been prevented from continuing to volunteer at a CAB because of their disability, namely because they were HIV positive, and therefore was seeking redress in the Employment Tribunal.

Discrimination legislation gives protection to those who are working under a "contract personally to do any work", and it was found as a matter of fact in this case that there was no legally binding contract between the CAB and the volunteer.

While this result will be a relief for organisations like the CAB, it is important to emphasise that it rests on the finding by the lower courts that the volunteer agreement was not legally binding. It is still possible to envisage cases where a volunteer is able to persuade an Employment Tribunal that a binding contract did exist, perhaps because in practice the organisation involved imposed the same kind of obligations on the volunteer as it would on a paid worker.

In addition, volunteers come in many forms and those volunteers who are seeking vocational training and/or practical work experience would have protection under European discrimination legislation that could be enforced in our domestic courts.

Guest contribution by
Kathryn Haigh, Associate
+44 (0) 1223 222525

Shared services: Mills & Reeve's Procurement Portal examines the key legal and practical issues

The use of shared services as a means of delivering savings and efficiencies is increasingly common within both Further and Higher Education sectors.   Sharing services can take a variety of forms, but generally involves institutions working or joining together to make savings or efficiencies through pooling knowledge, skills and resources in the development or delivery of services (most commonly administrative or back office functions).

Examples of this include:

• Two Further Education colleges deciding to jointly outsource their back office finance and payroll function to a private sector company.
• A university entering into a joint venture with a private sector company to provide HR and payroll services for both the university itself and other universities in the region.
• A spin-out employee mutual company providing services back to its originating university.

In the latest update to our Procurement Portal we explore the legal and practical issues associated with sharing services, including when shared services fall within or outside the EU procurement law regime, and also what lies ahead based on the proposals in the latest draft of the EU Procurement Directive (due to be adopted by the EU in 2014 and implemented in the UK in 2015).

If you need help with setting up a shared services arrangement, need to know whether the procurement rules will apply to your preferred model, or need any more information please contact Ruth Smith, our National Head of Procurement Law.

Guest contribution by
Ruth Smith, National Head of Procurement Law
+ (44) (0) 121 456 8434

Liability of educational organisations for external activities

Two recent cases explore the extent to which schools can be liable for external organised activities.  Whilst the cases concern schools, they will also be of interest to other educational organisations that arrange field trips, expeditions or activities using contractors.  In both cases the schools were held not liable, but the judgments provide a useful insight into how the law of negligence operates in this area.

In Woodland v Essex County Council, a pupil suffered severe injuries during a swimming lesson run for her school. The Council was responsible for the school. However, the lesson was provided by an independent contractor at a pool operated by another council.

The High Court concluded that the Council was not vicariously liable for the negligence of the contractor’s staff.  The normal principle of “vicarious liability” is that an employer is liable for damage caused by the negligence of its own employees acting in the course of their employment.  It is much harder to succeed with a claim that an organisation should have vicarious liability for non-employees.

An alternative argument was that the Council owed the pupil a direct “non-delegable duty of care”.  By a 2:1 majority the Court of Appeal held that the Council did not owe such a duty. 

In XVW & YZA v Gravesend Grammar School for Girls, the High Court held that neither a school nor a specialist expedition company were vicariously liable for the acts of a man who raped three girls on a school expedition in Belize, while they were working and staying on his farm.  Again the man was not an employee, nor had his involvement in the volunteer work undertaken by the expedition been sufficient to fix the school or company with vicarious liability.  Further, the court held that the school and the company had taken appropriate safety precautions during the expedition.

In both cases, the findings were made after a very detailed examination of the facts.  The courts’ reluctance to extend the scope of liability is due -in part- to concerns about effect of litigation on external activities.  In the Woodland case, one of the judges commented that to have imposed liability would have risked creating “a chilling effect on the willingness of education authorities to provide valuable educational experiences for their pupils”.

Budget 2012: Health & Safety law and the "compensation culture"

As part of the 2012 budget the Government has announced it intends to “scrap or improve 84 per cent of health and safety regulation, including legislating in 2012 so that ‘strict liability’ provisions in health and safety law will no longer hold employers to be in breach of their duties when they have done everything that is reasonably practicable and foreseeable to protect their employees.”

This is in line with the Government’s November 2011 response to the Lofstedt review of health and safety regulation.

Further legislation will set out the detail, and it remains to be seen how far these changes will achieve the Government’s stated aim of tackling the “compensation culture”.

Guest contribution by
Philip Grey, Associate (Barrister)
Tel: +(44)(0) 1223 222463
Philip.grey@mills-reeve.com