Changes from report parliamentary committee draft to plenary report

The Union general pharmaceutical legislation was established in 1965 with the dual objective of safeguarding public health and harmonising the internal market for medicines. The latest proposal of the European Commission for revision of this legislation includes a new Directive and a new Regulation to replace pharmaceutical legislation currently in force, with the overall objectives of promoting innovation, ensuring access to innovative and established medicines for patients, and creating a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation. Of the ‘Pharmaceutical Package’, this Directive contains all the requirements for authorisation, monitoring, labelling and regulatory protection, placing on the market and other regulatory procedures for all medicines authorised at EU and national level.

The Rapporteur supports the objectives of the European Commission’s proposal and finds that a revision of current Union general pharmaceutical legislation comes at the right time: Europe is increasingly falling behind other regions in pharmaceutical research and development investments, novel technologies challenge the existing legislative framework, and the COVID-19 pandemic demonstrated the need for timely and equitable access to medicines.

Incentivising Innovation

The Rapporteur believes that increasing the number of innovative medicinal products available to Europeans is of crucial benefit to patients and society. In this regard, the Directive must present a framework for rewarding innovation which is attractive to the global pharmaceutical industry, including the wider research-based life-science environment.

Making Europe competitive is an objective which requires a multifactorial solution. However, among the key factors, which is within the scope of this Directive, is the system of incentives and namely the regulatory data protection. Regulatory data protection affects companies’ decisions to invest in innovation and to bring scientific innovation to launch on the Union market. In this regard, the Rapporteur finds that the level of regulatory data protection offered on the Union market should be competitive with what is being offered in other markets. Furthermore, there should be certainty and long-term predictability regarding the level of regulatory data protection to be expected, which means that a significant amount of the total regulatory data protection should remain within the ‘baseline’.

The Rapporteur agrees with the European Commission’s proposal that further incentives on top of an attractive baseline of regulatory data protection may help steer innovation and finds that a definition of unmet medical need should be considered from both the individual patient and societal perspectives. That is, innovation for unmet medical need should be sufficiently incentivised, while the definitions applied for deciding which medicinal products address an unmet medical need should consider the patient perspective centrally. In this regard, the Rapporteur finds that the concept of ‘quality of life’ of patients should be considered.

Outside of regulatory data protection, the Rapporteur also proposes to increase the reward for completion of a paediatric investigation plan where this is completed for a different disease than the one for which a medicinal product is intended in the adult population.

Access to Medicines

The European Commission has proposed an incentive which will grant a prolongation of data protection if a medicinal product is supplied in accordance with the needs of the Member States concerned within two years from the marketing authorisation (or within three years in the case of SMEs, not-for-profit entities or companies with limited experience in the EU system). The Rapporteur opposes this measure, by which the European Commission intends to promote access to medicinal products. Firstly, because the release and continuous supply of medicinal products is not only within the control of the marketing authorisation holder but also relies on the Member State competent authorities. Thus, it would be disproportionate to place all responsibility, and direct consequences, for a failure to launch only on the marketing authorisation holder. Secondly, linking the failure to comply with the conditionality of supply in every Member State to losing out on regulatory data protection will be to the detriment of innovation, as described above. Finally, the Rapporteur is concerned about how this measure would work in relation to orphan medicinal products and ATMPs.

Rather, the Rapporteur proposes to place an obligation on marketing authorisation holders to submit in every Member State, which requested them to do so, an application for pricing and reimbursement. In case of non-compliance with the obligation, a proportional financial penalty shall be applied by affected Member States. This can promote access to medicinal products across Europe, while ensure predictability in the expectations, as well as in the possible penalties, of marketing authorisation holders. Marketing authorisation holders of orphan medicinal products and ATMPs shall be subject to an adapted obligation, and in special cases the European Commission may exempt specific medicinal products. To further the processes surrounding the obligation, the European Commission shall set up an “EU Access to Medicines Notification System”.

Environmental Health

The Rapporteur welcomes the initiative of the European Commission to strengthen measures related to the environmental impact of medicines, and, by extension, the impact on human health of negative environmental impacts. However, these should be proportionate and not unjustly have a negative effect on patients.

Notably, the Rapporteur finds that in case of serious risks to the environment a marketing authorisation may be suspended or varied, but should only be revoked in cases where those risks clearly outweigh the loss of positive therapeutic effect of the medicine. The Rapporteur also asks the Commission to ensure that the proper guidelines for conducting environmental risk assessments for antimicrobials other than antibiotics are in place before obligations in this regard shall apply. When specifying technical details for the environmental risk assessments, all relevant stakeholders shall be consulted. As regards medicines for which a prescription is needed, the Rapporteur wishes to ensure continued patient access to antimicrobials not for systemic use.

The Rapporteur suggests to place extended obligations on the Member States with regard to the appropriate collection and management of unused or expired medicines. In this regard, Member States are asked to draw up national plans, including measures designed to inform the public and healthcare professionals about environmental risks in regard to incorrect disposal of medicines and increase its rate of correct disposal of medicines.

Patient-centred Information

The Rapporteur places emphasis on the importance of properly ensuring accurate information to patients about the medicines they consume. The first objective of package leaflets shall be to meet the needs of patients. Whether the leaflet is in electronic or in paper format, its content must be legible, clear and easy to use. The Rapporteur proposes that the package leaflet shall contain a ‘key information section’ to support this objective.

The addition by the European Commission of electronic information can, in this regard, benefit some patients. However, where no other position has been taken, the information should be available in the form of both paper leaflets and electronic product information. The decision to make information available only electronically shall lay with each Member State, and in this case, patients shall be made aware of their right to a printed copy. However, where the medicinal product is not intended to be delivered directly to, and administered by, the patient the Commission may take the decision to make only the electronic product information mandatory.

Awareness cards shall be available in paper format, or in both paper format and electronically, to support that this information is duly received by patients. The Rapporteur supports the proposal of the European Commission that Member States may make exemptions to the language requirements of labelling, however, patients should, in this case, still be able to request a copy in the official language of their Member State.