#Health: ‘PRIME’ scheme should bring access to new drugs close

This week, the European Medicines Agency (EMA) launched its PRIME scheme. This stands for PRIority MEdicines and is intended to “strengthen support to medicines that target an unmet medical need”, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Health and Food Safety Commissioner Vytenis Andriukaitis said: “The launch of PRIME is a major step forward for patients and their families that have long been hoping for earlier access to safe treatments for their unmet medical needs, such as rare cancers, Alzheimer’s disease and other dementias.”

He added: “Through enhanced scientific support this scheme could also help, for example, to accelerate the development and authorization of new classes of antibiotics or their alternatives in an era of increasing antimicrobial resistance.”

Andriukaitis also pointed out that the PRIME scheme optimises the use of the current regulatory framework that can contribute to the European Commission's priorities in terms of boosting innovation, jobs, growth and competitiveness.

The novel EMA scheme has been heavily backed by stakeholders, such as the European Alliance for Personalised Medicine (EAPM), which has long-campaigned for such programme. In the run-up to its launch, PRIME’s main principles were released for a two-month public consultation, taking into account stakeholder commentaries.

EAPM has worked hard lobbying for better access for patients to new medicines and this was a main thrust of the Luxembourg Presidency of the EU’s Council Conclusions on personalised medicine released in December 2015.

Now, recognising the need to define barriers and develop putative solutions to the issue of patient access, the Brussels-based Alliance runs a Working Group on Access that exists to develop policy recommendations. It is currently looking at ways to ensure that the Grand Duchy’s Council Conclusions are implemented.

Part of the access problem concerns the EU’s directive on patients' rights to cross-border care - which has certainly has not been properly implemented Europe-wide and offers a graphic demonstration of just how far the EU28 remains from any real coherence on health policy and on innovation.

The effectiveness of the directive depends on collaboration at European level. But that sort of collaboration is in very short supply when the EU tackles many aspects of health - a deficiency that threatens to undermine what is a well-intentioned initiative.

There has been a persistent failure to put in place effective cooperation on health at a European level and there is a clear need for the cross-border directive to act as a spearhead of the change that will benefit innovation.

PRIME represents good news. The scheme is focused on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients with no treatment options. These are considered priority medicines within the EU.

Through the scheme, EMA states that it “offers early, proactive and enhanced support to medicine developers to optimise the generation of robust data on a medicine’s benefits and risks and enable accelerated assessment of medicine applications. This will help patients to benefit as early as possible from therapies that may significantly improve their quality of life”.

It aims for early engagement with medicine developers, in order to strengthen clinical trial designs in this age of high-quality data, while ensuring early dialogue and scientific advice to allow patients to participate in trials that are likely to provide data for an application for marketing authorisation.

Indeed, EAPM’s EU Consensus Group on Clinical Trials was formed to address whether a personalised medicine-enabled clinical research and trial strategy can produce better outcomes, specifically for cancer patients.

The current focus of the group’s activity is prioritising the challenges and proposing workable solutions.

An important part of the work undertaken by EAPM concerns clinical trials and patient access to them. One of the four-year-old Alliance’s main aims is tackling the broader issues of personalised medicine in terms of clinical trials, as well as biobanks, data sharing, EU regulations and more, while looking towards the EU’s Horizon 2020 initiative.

Clinical trials are vital to patients and the advancement of cures for a multitude of diseases, but the issues surrounding countrywide and, even more so, pan-European trials and their application in modern-day medicine are complex.

The consensus panel was brought together in an attempt to define how personalised medicine cancer clinical trials should be organised in order to direct patients to the most appropriate research as well as addressing important unmet needs.

This ties in well with PRIME. Professor Guido Rasi, EMA’s Executive Director, said: “Our goal is to foster better planning of medicine development to help companies generate the high quality data we need to assess quality, safety and efficacy of medicines,” adding that: “Patients with no or insufficient treatments could then benefit from scientific progress and cutting-edge medicines as soon as possible.”

The EMA goes on to state that PRIME “builds on the existing regulatory framework and available tools such as scientific advice and accelerated assessment”. Thus, a PRIME drug should “benefit from accelerated assessment at the time of an application for marketing authorisation”.

PRIME should dovetail with the European Commission’s Expert Group on Safe and Timely Access to Medicines for Patients, otherwise known as STAMP, which began its work in January 2015.

According to the Commission, the STAMP expert group has been set up to provide advice and expertise to Commission services in relation to the implementation of European Union pharmaceutical legislation, as well as programmes and policies in the field. 

STAMP is intended to “exchange views and information about the experience of member states, examine national initiatives and identify ways to use more effectively the existing EU regulatory tools with the aim to further improve safe and timely access and availability of medicines for patients”.

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