In a world where half of all clinical trial delays are caused by patient recruitment problems there is always pressure to streamline and simplify the recruitment process, including getting informed consent from trial subjects. As a result new forms of consent are appearing in the US and elsewhere, but how legal are they in the UK and other parts of the EU?
Biopharma/Medtech in the news
The future of biomarker-based diagnostics products in Europe
Diagnostic tests, whether for use in the lab or at home, based on newly validated biomarkers, will form a significant part of the future of disease prevention and early detection, and a major element of the recent 2010 BIO Convention focussed on biomarkers and their likely contribution to products across a diverse range of therapeutic groups. But obstacles – man-made rather than scientific – may stand in the way of quickly and effectively launching those products in Europe unless legal reforms are undertaken soon.
Got a letter of intent, memorandum of understanding, heads of agreement? OK – so what does it mean?
Terms such as “letter of intent”, “memorandum of understanding” and “heads of agreement” are often bandied about in business on documents which are intended somehow to fall short of a “full” contract, but what exactly are they and, in particular, what effect do they have if the parties subsequently fall out?
It’s getting easier for inventive employees to take a bite out of the company’s profits
Usually if an employee creates a new invention or other intellectual property in the course of his or her employment it belongs to the employer. Even if those rights go on to make the employer millions the employee is entitled only to his or her salary. However, for many years there has been an exception to this rule in UK patent law, entitling the inventive employee in this scenario to a “fair share” if a patented invention which he or she created is of “outstanding benefit” to the employer.