Medicines and Healthcare products Regulatory Agency

PIPA agree with the principle that ALL current SmPCs and PILs should be readily accessible on the internet to support clinical decision making, patient safety and knowledge. This is irrespective of the form of marketing authorisation (eg MRP, national license).

As the MHRA describe that they already have a definitive database of these documents internally, it makes sense for this primary source to be made accessible - so long as this can be achieved efficiently and cost effectively for the MHRA, industry, healthcare professionals and patients. Indeed, PIPA recognise that other competent authorities already do this eg IMB, EMA (within EPARs) and FDA.

PIPA highlight that many pharmaceutical companies already maintain access to their SmPCs and PILs, either through the Datapharm EMC or their own websites. Both options incur costs, either directly eg Datapharm fees or indirectly, eg resource time. There are manual processes to upload and quality check files and, understandably, a small timelag between the approval of a document by the MHRA and it being visible to patients and healthcare professionals. While most pharmaceutical companies make every effort, the proposal for the MHRA to provide access to their definitive resource online should remove the risk of out-of-date or incorrect information being viewed or information not being found.

PIPA acknowledge that the Datapharm EMC resource is well-regarded and valued by many users. However, PIPA have mixed views on the appropriateness for the MHRA to partner Datapharm, a commercial organisation, on this initiative or enforce all Pharmaceutical companies to publish on their EMC.

In many ways it would be very useful to link SmPCs to the relevant sections within the British National Formulary (BNF), especially for healthcare professionals. However, PIPA recognise that the BNF does not currently include all licensed medicinal products or classes and is not accessible through computers with a non-UK IP address.

The ideal webtool will be comprehensive and easy to navigate, with options to print (range of formats) and export documents. Considering patients needs, PIPA propose that a dedicated website, linked to and from the MHRA, would be best. Everyone should be able to view all documents, although patients should be guided towards the PILs, rather than the more complex SmPCs. It should also be acknowledged that the PIL version online may be more recent than the one supplied in the patients pack (due to the time since manufacture).

PIPA and the pharmaceutical industry are committed to facilitate patient care. We support efficient access to all appropriate information to aid clinical decision making, patient safety and knowledge.

NB - Some individual pharmaceutical companies have not been able to interact with this style of open-access discussion/consultation due to corporate communication policies.