The consultation by the European Commission on its proposal for the new European Pharmaceutical Strategy – an integral part of the broader EU’s Industrial Strategy – closed on 15 September (242 comments receveid, see here); the final launch is expected by the end of the year. Among the main challenges for  the key pharmaceutical sector are the redefinition of the entire life cycle for medicinal products, the translation of emergent science and technology into practice, the need to invest to develop new antimicrobial agents and how to better prepare to possible new pandemics.

An online workshop organised by DG Santé has took place on 14 and 15 July with a selected group of stakeholders as a discussion moment supporting the ongoing consultation process. Many stakeholders have also released official statements highlighting their priorities to be included in the new strategy.

The proposals from the Dutch Parliament

The Dutch Parliament issued a detailed document on key points to be taken into consideration, starting from an holistic approach to build an all-inclusive, evidence-based pharmaceutical strategy. Sharing of studies’ results with member states is considered an essential element to support transparency and cooperation and  to respond to real needs expressed by the stakeholders.

A jointly-developed working plan on pharmaceutical policy 2020-2025 is suggested as the operative tool to ensure cooperation between the Commission and member states in the definition of goals and short-term activities, in order to achieve clear and transparent governance and procedures. The Dutch representatives asked for coherence across all ongoing and upcoming EU policies. No matter to say, innovation should play a central role in the identification of unmet medical needs; with this regard, the incoming legislation is expected to adapt to the new challenges arising from digital, scientific and technological advances while ensuring regulatory flexibility, harmonisation of procedures and an easier access to the market. Advanced therapy medicinal products (ATMPs) and paediatric medicines are among the priorities identified.

A better characterisation of vulnerabilities along the supply chain and an improved cooperation at the European level should help to face the issue of shortages; multi-language packaging information and e-leaflets may represent additional tools, as well as a better resilience to threats similar to those faced during the Covid-19 pandemic. Preliminary discussion on a possible European list of essential medicines may support initiatives directed to the EU’s active pharmaceutical ingredient industry.

Joint Health Technology Assessments (HTA), says the Dutch Parliament, may represent a form of voluntary collaboration to improve transparency and equal access to medicines across Europe. The debate on R&D costs may impact both shortages and fair access: “As prices escalate, it is legitimate to question the degree of innovation and value offered by certain new, high-cost therapies. The sustained financial performance of pharmaceutical companies further underwrites the assumption that current prices do not accurately reflect the costs of production and research and development. Furthermore, even though public funding often supports the R&D of many new pharmaceutical products, current pricing practices of some companies do not reflect their social responsibility to contribute to the sustainability and affordability of health care.”, wrote the Dutch Parliament. Marketing of a new medicines in all EU countries should be compulsory upon approval through a centralised procedure, is one of the suggestions. The document also discusses how to tackle the environmental impact of pharmaceuticals and the related issue of antimicrobial resistance.

The voice of community pharmacists

The Pharmaceutical Group of the European Union (PGEU) on behalf of community pharmacists also forwarded its comments on the Pharmaceutical strategy. The  Group supports a more European supply chain for the production of APIs, excipients and finished products, particularly those more critical in terms of supply. A fair framework for pharmaceuticals, comprehensive of guarantees for security of supply for patients, is the suggested tool to face this challenge.

A stronger enforcement of the marketing authorisation holder’s (MAH) responsibilities and a closer cooperation between public institutions and national governments are the options considered most effective in enhancing the quality of medicines. The problem of shortages represents a great concern for community pharmacists, which need to invest many time and resources to deal with it. PGEU proposes that the pharmacist would be allowed to substitute the missing productwith the most appropriate alternative as part of a shared decision-making process with prescribers and patients or in accordance with national protocols where appropriate”.

Community pharmacists also commented the practice of market withdrawals for commercial reasons, which mostly affect cheaper and older products. When no or little alternatives are available on the market, the request is to ensure sufficient safeguards to ensure continuity of access, for example through the permission to pharmacists to prepare compounded formulations if possible. 3D printing may also represent a valuable technology to be used within pharmacies, but according to PGEU a tailor-made regulatory framework, as well as  financial investment and reimbursement for this technology would be needed.

Commercialisation of the smallest package relevant for a specific treatment is envisaged to reduce the environmental impact of pharmaceutics. PGEU also suggests an expansion of community pharmacy services, for example for the home delivery of medicines in selected cases, or the safe renewal of repeat prescriptions for chronic medications.

Focus on fighting antimicrobial resistance

The members of the MEP Interest Group on AMR of the European Parliament on October 6th addressed a letter to the EU Commission’s VP for Promoting our European Way of Life, Margaritas Schinas, and Health Commissioner, Stella Kyriakides, to highlight the main issues regarding antimicrobial resistance to be considered the final version of the pharmaceutical strategy. 

The EP suggested to better integrate the development and access to new affordable and quality antimicrobials, with an eye on their environmental sustainability. The key recommendations are in line with the Parliament’s resolution on the EU’s public health strategy post-Covid-19, and include a stronger role of the Union in global discussions about antibiotic shortages and a special attention to the resilience of supply chains to disruptions. 

Another instance to be faced is the impact of market failures in antibiotic R&D; the suggestion by the MEP  Interest Group goes towards the adoption of an end-to-end approach and the development of needs-driven models to fix the antibiotic development pipeline. Prevention represents a valuable tool to reduce dependance on antibiotics and improve research into possible alternatives, such as phage therapy. 

The goal of a better transparency in the pharmaceutical industry should be based, according to the letter, on a strong legislative framework able to take into consideration all aspects, from R&D to authorisation procedures and environmental risks. This last issue should be tackled through more tight manufacturing requirements, i.e. including the development of antimicrobial resistance in the Environmental Risk Assessments. Quality standards and concentration limits in water and soil should also be set.