EUROPEAN COMMISSION Brussels, 22.3.2017 COM(2017) 135 final REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL in accordance with Article 59(4) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use



(Text with EEA relevance)



REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL in accordance with Article 59(4) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use



(Text with EEA relevance) 1.Introduction This report is prepared pursuant to Article 59(4) of Directive 2001/83/EC according to which the Commission shall present to the European Parliament and the Council an assessment report on current shortcomings in the summary of product characteristics and the package leaflet and how they could be improved in order to better meet the needs of patients and healthcare professionals. 2.Regulatory Framework The summary of product characteristics (SmPC) the content of which is described in Article 11 of Directive 2001/83/EC and the package leaflet (PL) the content of which is described in Article 59 of Directive 2001/83/EC form an intrinsic and integral part of the marketing authorisation for medicinal products in the Union in accordance with Article 6 of Directive 2001/83/EC and Article 3 of Regulation (EC) 726/2004. Article 8(3)(j) of Directive 2001/83/EC and Article 6(1) of Regulation (EC) 726/2004 require that, in order to obtain a marketing authorisation, a SmPC and a PL must be included in the marketing authorisation application. Detailed guidance on the correct implementation of the abovementioned legal requirements is provided in the regulatory guidelines, in particular: Guideline on Summary of Product Characteristics ("SmPC Guideline"); Guideline on the packaging information of medical products for human use authorised by the community ("Packaging Information Guideline"); Guideline on the readability of the labelling and package leaflet of medicinal products for human use ("Readability Guideline"). Further practical guidance can be found in the templates of the Quality Review of Documents group (QRD templates). The QRD templates provide the official wording to be used in the SmPC and PL in accordance with Directive 2001/83/EC. The aim of the QRD templates is to achieve consistency across different medicinal products and across all Member States. The templates define standard headings, standard statements and terms and the format and layout to be used.

When the marketing authorisation is issued by the competent authorities of the Member States, the Marketing Authorisation Holder shall be informed of the SmPC as approved by them and the national competent authority concerned shall, without delay, make publicly available the marketing authorisation together with the package leaflet and the summary of product characteristics. For decisions concerning centralised marketing authorisations, according to Article 10 of Regulation (EC) No 726/2004, the final Commission decision with the SmPC and the PL is addressed and notified to the Marketing Authorisation Holder. After a marketing authorisation has been granted the content of the SmPC cannot be changed except with the approval of the competent authority that granted the marketing authorisation. The SmPC is the basis of information for healthcare professionals on how to use the medicinal product safely and effectively. It is not in the remit of the SmPC to give general advice on the treatment of particular medical conditions. On the other hand specific aspects of the treatment related to use of the medicinal product or its effects should be mentioned in the SmPC. Similarly, general advice on administration procedures should not be included but any advice specific to the concerned medicinal product should be included. The PL provides a set of comprehensible information enabling the use of the medicinal product safely and appropriately. The package leaflet is primarily intended for the patient/user. If the package leaflet is well designed and clearly worded, this maximises the number of people who can use the information, including older children and adolescents, elderly, those with poor literacy skills and those with some degree of sight loss. 3.Assessment The Commission engaged external contractors to produce two studies in order to provide supporting information for this report. Details of these two studies are provided below. 3.1.Study on the Package Leaflets and the Summaries of Product Characteristics of Medicinal Products for Human use ("PIL-S Study") The study has been carried out by NIVEL (Netherlands Institute for Health Services Research) together with the University of Leeds. The objective of this study was to provide the European Commission with: an assessment of the readability and comprehensibility of the SmPC and the PL as sources of information on prescription and non-prescription medicines for patients and healthcare professionals; an assessment of the causes and (potential) consequences of identified shortcomings, and recommendations for improvement of the SmPC and the PL of prescription and non-prescription medicines based on this assessment. The assessment included an extensive literature search, a European-wide stakeholder survey (including representatives of patients and consumers organisations, healthcare professionals, pharmaceutical industry and entities engaged in user testing) and an online discussion forum. 3.2.Study on the feasibility and the value of a possible “key information section” in patient information leaflets and summaries of product characteristics of medicinal products for human use ("PILS-BOX Study") Also this study has been carried out by NIVEL and the University of Leeds. The objectives of the PILS-BOX study were: to collect existing evidence on the potential impact of adding a key information section on the safety and efficacy of medicines’ use; to assess the feasibility of adding a key information section in the context of the EU legislation; to assess the potential cost/efficacy of adding key information in the context of the EU legislation. The assessment included an extensive literature search, a European-wide stakeholder consultation and an analysis of the Strengths, Weaknesses, Opportunities and Threats (SWOT analysis). 3.3.Input from stakeholders and Member States

As part of the two studies a European-wide stakeholder survey has been conducted in which the key stakeholders were asked to provide their views on existing strengths and shortcomings of the SmPC and PL. The results of the survey have been taken into account in the conclusions of both studies and also in this report. Once finalised the two external studies have been published on the Commission website and submitted for consultation to the Member States in the framework of the Pharmaceutical Committee. The Member States comments have been summarised in a document published on the Commission website and duly taken into account in this report. The European Medicines Agency services collaborated closely with the Commission in the course of preparations of this report and provided valuable input related, for example, to the activities of the Working Group on Quality Review of Documents (QRD) and other areas of Agency's expertise. 4.Outcomes and recommendations Based on the above mentioned assessment the following outcomes and recommendations have been identified. It has been generally considered that the current EU legislation on medicinal products for human use allows for enhancement of the statutory medicines information to support the safe and effective use of medicinal products. The below recommendations should be, therefore, primarily taken forward by improvements of the existing regulatory guidelines, templates and other non-legislative means. 4.1.Room for improvement of PL rather than of SmPC As far as the PL is concerned, patient’s comprehension of the PL and its readability can be improved. The language used is often too complex and the design and lay-out are not always user-friendly. The elderly and those with low literate skills are particularly disadvantaged, but generally these problems hold for all patient groups. On the other hand, less problems were identified with regard to the SmPC although improvements can still be made especially with regard to the readability of the SmPC. Representatives of healthcare professionals generally judge the quality of the SmPC as reasonable and value most of the current topics addressed in the SmPC as being important. Recommendation: Generally, there should be more focus on improving the PL rather than the SmPC. However, for any potential improvement of the PL it should be also considered whether a corresponding or related change of the SmPC would be appropriate. 4.2.Amendments of Guidelines and QRD templates to enhance readability of PL Content and layout-related issues have been identified in the PIL-S Study. It is considered that future work on guidelines relating to the PL, and possibly also the SmPC to some extent, has the potential to solve a number of these issues. Guidelines should include more details on the principles of good information design in which content and layout are jointly considered. This would help to ensure compliance with the legal requirement that the PL shall be "clearly legible". Moreover improvements related to the language used would help to ensure that the information is "clear and understandable" as also required by the legislation. These issues could be best addressed by improving the existing guidelines, in particular the Readability Guideline, the Packaging Information Guideline and, where appropriate, the SmPC Guideline. The relevance and importance of the QRD template is also acknowledged in this respect as it is the main tool to provide guidance to the industry in a harmonised way. The QRD template should rely on principles of good information design and pay attention also to the needs of some specific groups of patients, such as elderly, young people or people with mental illnesses. Small font size, narrow line spacing and the length of the PL were identified as the main issues. Guidelines and QRD templates are also considered too restrictive in some respects. They should allow for more flexibility to adapt the PL to the specificities of each product whilst respecting the limits provided by the legislation. Deletion of some information that is currently required by the QRD template but that is of limited relevance for patients may allow more space to improve the content and layout of package leaflets and should, therefore, be considered. More attention should be also paid to the translation of the user-tested PL into other languages. It is considered important to keep the ‘lay-ness’ of the user-tested version when the leaflet is translated. Recommendation: It should be considered to revise the existing guidelines, in particular the Readability Guideline, the Packaging Information Guideline and, where appropriate, the SmPC Guideline to include principles of good information design and consider allowing more flexibility in the information recommended in the QRD template, as long as the relevant legislation allows it. These revisions should also include introduction of guidance on translations that go beyond the principle of faithful translation. The aim should be to ensure that the lay language introduced through user testing in the original language version is not lost during translation. 4.3.Improving patient input in developing and testing of PLs The assessment recognised the usefulness of patient involvement and the importance of user testing of the PL. It is equally important that methodology for such testing is well defined. The assessment further identified the need for strengthening the input from the patient perspective which could also help in getting more understanding on how to present risk-benefit information for a particular medicine.