The European Commission issued a report on 28 March 2017 on recommendations to improve the information provided through Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for approved drugs. Released on the basis of Directive 2001/83/EC on the Community code relating to medicinal products for human use, the report was originally expected in January 2013.
The Report takes into account (i) the result of two studies, a Study on the Package Leaflets and the Summaries of Product Characteristics of Medicinal Products for Human use (referred to as PIL-S) and a Feasibility and value of a possible “key information section” in PIL and SmPC of medicinal products for human use (referred to as PILS-BOX), carried out by the NIVEL and the University of Leeds and funded under the EU Health Programme, (ii) as well as input from an EU-wide survey of stakeholders and member states.
The studies were aimed at assessing the readability and comprehensibility of the SmPC and PIL and to determine whether a "key information section" - that would call attention to particularly relevant information about a drug to ensure its safe and effective use - should be added to PIL and SmPC of drugs.
The SmPC, the content of which is described in Article 11 of Directive 2001/83/EC, and PIL, 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) 726/20043. 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 PIL must be included in the marketing authorisation application. 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.
Once finalised, the two studies have been submitted for consultation to the Member States. The Member States comments have been summarised in a document published on the Commission website and duly taken into account in the report.
Recommendations from the European Commission
The Commission considers there is currently not enough data to evidence that adding a key information section would be useful to healthcare professionals (HCPs) and patients, and says it will look to work being done by the European Medicines Agency (EMA) to test a similar concept for EPARs to help inform whether adding the section can be of use.
The Commission also considers there is more room for improving PIL than for SmPC: "As far as the PIL is concerned, patient's comprehension of the PIL and its readability can be improved. The language used is often too complex and the design and layout 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".
It should be emphasized that the EMA currently has several guidelines to assist manufacturers with developing the SmPC and PIL for their products, and the agency's Quality Review of Documents (QRD) working group has produced a number of templates detailing the official wording that should be used in the documents in order to promote consistency across various products. The Commission recommends in its report that the EMA should update its guidelines and QRD templates to simplify the information provided and improve their layout. According to the Commission: "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"". The Commission meanwhile notes that small font size, narrow line spacing and overall length of the PIL were the main offenders in respect of readability and comprehensibility of PIL.
Additionally, the Commission says the guidelines and QRD templates are "too restrictive", and recommends they be amended to allow for more flexibility to be tailored to specific products. When it comes to developing the PIL, the Commission says that the process for gathering patient input could be improved by making the user testing process more iterative.
The report evidences a clear trend in healthcare regulators in Europe to empower patients, sometimes at the risk of reducing greatly the role of HCPs, who are primary and essential in providing information to patients in relation to the conditions of use and associated risks of a medicine.
Indirect impact on liability for defective products
The report may trigger, in coming months, substantial amendments of SmPC and PIL, with possible deletions of certain section of information to leave room for more detailed information - one may think of condition of use and adverse reactions. But life sciences companies should already pay close attention to the critics raised against the lack of optimal readability and comprehensibility of information contained in the PIL, as such critics could potentially be raised by plaintiffs in product liability cases.
Article 6 of Directive 85/374/EEC on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products defines a product defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account, including (i) the presentation of the product; (ii) the use to which it could reasonably be expected that the product would be put; (iii) the time when the product was put into circulation.
Applying this article to product liability litigation, courts from most of the EU member states consider that the information for use and possible adverse reaction in the SmPC and/or PIL are key in assessing whether a medicine is defective.
The question raised in product liability cases as to whether the patient has been properly put in the situation to understand the seriousness and likeliness of the adverse reaction may also derive from the assessment of the content and readability of the PIL. In other words, the point that could be raised by plaintiffs to the courts is not to confirm whether the information on a specific adverse reaction or specific warning for use is mentioned in the PIL, but rather if the information was provided in words that are comprehensible by the layman.
In fact, Member States commenting on the PIL-S and PLI-BOX studies reflected “on the dual function of the PIL: a legal function for "full disclosure" of the undesirable effects included in the SmPC, and a communication function for the patient/the user of the product. While comments consider that any known risk should be disclosed regardless of its frequency/probability, there is a general agreement with the conclusion of the studies that the communication function may be improved within the current legal framework.”
It is indeed often criticised that PILs emphasize on topics that are not necessarily usable information to the patients, but mainly on what is mandatory under applicable regulation. Companies are bound in this regard by rigid regulation.
While the trend is to reflect more or less the content of PIL to that of the SmPC, the studies that have been the basis of the report from the European Commission emphasize to a certain extent the need to distinguish between PIL and SmPC in terms of content and vocabulary used, taking into account the central role played by learned intermediaries such as HCP and pharmacists for drugs available under prescription, or pharmacists for OTC drugs, in order to ensure appropriate information and understanding of safety and use conditions. At the end of the day, it should also reverse biased case law from some courts inferring defect of a product from mere comparison of content between PIL and SmPC.
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