On 23 March 2017, the European Commission (EC) released a report to the European Parliament and the Council setting out its recommendations to improve information provided to patients and healthcare professionals through package leaflets (PLs) and summaries of product characteristics (SmPCs) for approved medicinal products. The report was released pursuant to Article 59(4) of Directive 2001/83/EC whereby the EC is to report to the European Parliament and the Council on the current shortcomings in SmPCs and PLs and how these could be improved.
The PL and the SmPC form an integral part of receiving marketing authorisation (MA) for a medicinal product in the EU as, in order to obtain an MA, a PL and SmPC must be included in that MA application (Article 8(3)(j) of Directive 2001/83/EC and Article 6(1) of Regulation (EC) 726/2004). Article 11 and Article 59 of Directive 2001/83/EC describe the content required to be included in an SmPC and an PL, respectively.
The SmPC is the basis of the information used by healthcare professionals on how to use the medicinal product safely and effectively. The SmPC does not need to give general advice on the treatment of a specific medical condition, however, specific aspects of treatment related to use of the medicinal product or its effects should be included in the SmPC. On the other hand, the PL should provide comprehensible information aimed primarily at the patient / user of the medication as to the safe and appropriate use of the medicinal product.
There is currently detailed regulatory guidance on SmPCs and PLs and the readability of the information to be included therein as well as practical guidance in the form of a template SmPC and PL from the Quality Review of Documents group (QRD) of the European Medicines Agency (EMA). The guidance and the templates aim to bring consistency in the information provided in relation to different medicinal products and across different EU member states.
When an MA is issued by a competent authority of a member state, the PL and SmPC will be made publicly available, pursuant to Article 21(3) of Directive 2001/83/EC. After the MA has been granted, the contents of the SmPC cannot be changed except with the approval of the competent authority that granted that MA.
The EC’s report sets out its basis, namely, the results of two studies commissioned by the EC: one carried out by the Netherlands Institute for Health Services Research (NIVEL) and one carried out by the University of Leeds. The two studies were commissioned to provide the EC with results as to the readability and comprehensibility of SmPCs and PLs, and to determine whether a ‘key information section’ should be added to both the SmPC and the PL. A ‘key information section’ would aim to enhance the readability of the PL or SmPC by allowing patients and healthcare professionals to quickly identify key safety messages as well as setting out information on the benefits of the medicine.
The EC concluded that it is too early to tell whether a ‘key information section’ should be included in SmPCs or PLs – further experience and evidence is needed. It said that there is not yet enough evidence to show how useful a ‘key information section’ would be, however, it will look at work being done by the EMA in relation to adding a ‘key information section’ to its European Public Assessment Reports (EPARs). The work being carried out by the EMA in relation to EPARs has been to test whether improvements can be made to information provided to patients and health care professionals in relation to benefit-risks for each centrally authorised medicinal product. This could help in deciding on the type of information that could be provided in a ‘key information section’ and the category or type of medicines where such a ‘key information section’ could be useful and appropriate.
The report makes six recommendations which the EC says should be primarily taken forward by improvements to the existing regulatory guidelines, templates and by other non-legislative means:
- More focus should be given to improving the PL rather than the SmPC (by simplifying the language used and improving design and layout to be more user-friendly, particularly for the elderly and those with low literacy skills);
- Amendments to the existing PL guidelines and the PL QRD template should be made to enhance the readability of PLs (principles of good information design should be included and there should be more flexibility in the information recommended to be included in the QRD template. There should also be guidance on translations to ensure that lay language introduced through user testing in the original language is not lost in translation);
- Improvements should be made to increasing patient input in developing and testing PLs (user testing should be more iterative and coordinated by regulatory authorities in parallel to the MA assessment process but should be carried out in a way that does not disrupt the MA process);
- Best practice should be promoted and exchanged (examples of best practice in relation to the PL and the SmPC could be made available to pharmaceutical companies on a suitable platform which is regularly updated);
- Use of electronic media to provide the information included in the SmPC and the PL should be considered (in particular, developing mechanisms through electronic tools to inform patients and healthcare professionals of changes to the SmPC or PL. Work in this area should be based on, and further develop, work already being carried out by the EMA in this regard); and
- Potential use of ‘key information sections’ in the SmPC and the PL to allow patients and healthcare professionals to quickly identify the crucial safety messages and key benefits of the medicinal product.
The EC has said that it will work with the EMA towards implementation of the above six recommendations in order to improve certain aspects of the SmPC and the PL. It will also work closely with member states and ensure that key stakeholders are appropriately consulted and involved with regard to the proposed recommendations.