Out-Law News | 09 Sep 2014 | 3:39 pm | 2 min. read
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) said that the groups participating in the three year 'WEB-RADR' project will "investigate the potential for publicly available social media data for identifying potential drug safety issues". It said the information assessed as part of the project "will be appropriately anonymised to protect data privacy".
The MHRA is leading a consortium of other medicines regulator, academics and drugs companies from across Europe in conducting the study.
"The recent growth of social media platforms such as Facebook, Twitter and the many specialist sites and blogs has given rise to many people sharing their medical experiences publicly on the internet," Mick Foy, group manager of MHRA’s vigilance and risk management of medicines division, said. "Such data sharing, if properly harnessed, could provide an extremely valuable source of information for monitoring the safety of medicines after they have been licensed."
The WEB-RADR project will also see work undertaken to develop a new mobile app that allows suspected adverse drugs reactions to be reported to regulators by either health professionals or the public. The MHRA said the app could also be used for sending "accurate, timely and up to date medicines information to patients, clinicians, and caregivers" and that the WEB-RADR study would "examine the value of these new tools for monitoring drug safety".
Funding for the project is being provided by the Innovative Medicines Initiative (IMI), which is a body backed by both the European Commission and the European Federation of Pharmaceutical Industries and Associations.
Another IMI research programme, the 'GetReal' project, is also exploring how "real-world" information can be used and analysed to inform the development of new drugs, including in relation to how clinical trials are designed.
In a paper published earlier this year, Pinsent Masons, the law firm behind Out-Law.com, highlighted the impact that advancements in technology can have in speeding up the development of better targeted medicines.
Drugs companies must adhere to a number of strict regulatory requirements before new drugs can be put on general sale, but new ways of speeding up that process are being explored. This includes an 'adaptive licensing' model which lets drugs companies gain regulatory approvals for the use of innovative new drugs on a graduated basis, with permissions for use for treating life threatening illnesses initially limited but expanded on the basis of further testing and development they undertake.
"Connectivity and a move away from what used to be standalone business approaches and interests, including open source approaches to drug discovery, collaborative projects to generate real time data early in the development process and advancements in data analytics are facilitating the development of a more streamlined and flexible regulatory process that will allow patients access to innovative drugs, and at an earlier stage along the drug development pathway," Pinsent Masons' 'Connectivity in the Life Sciences and Healthcare Sectors' paper (20-page / 1.58MB PDF) said.
Life sciences expert Helen Cline of Pinsent Masons, the law firm behind Out-Law.com, said that the digital age is “changing the global landscape in regulation of health care products”
“In this changing environment the industry, healthcare professionals and patients are calling for faster access to new and innovative therapies but the role of the regulator remains unchanged – to ensure that health products are safe, efficacious and of good quality,” Cline said. “However our regulatory frameworks have to adapt to new requirements and paradigms to ensure timely mitigation of risks to safeguard public health. Various initiatives including the EMA’s adaptive licensing pilot are aimed at lowering market entry barriers with greater emphasis on post-marketing data gathering. As well as social media platforms, electronic health records are another potential rich source of drug-safety signals that could be further exploited.”