Global virtual conference on track – Effective care with the EU’s in vitro diagnostics regulation

Good afternoon, and welcome to the latest update from the European Alliance for Personalised Medicine (EAPM). The upcoming virtual EAPM conference takes place just next week, and we have thoughts on IVDR, writes EAPM Executive Director Dr. Denis Horgan.

Global Virtual conference

Next Wednesday, on 27 October, a virtual conference/webinar will take place run by EAPM. The banner title is 'A destination in sight:  Doing it right to bring personalised healthcare to patients’. We would like to take this opportunity to invite you to join us for this key event. You can register here and click on the link to view the agenda here. 

Health-care systems are not always ready to respond to the opportunities. The disruptive nature of personalised care and COVID-19 challenges traditional patterns of thinking. Practices, presumptions and even prejudices that date from before the millennium resist a 21st century approach to health care. A policy discussion is needed to realise the potential of personalised healthcare globally and empower scientific enterprise that can benefit the population of the entire planet.  The conference next Wednesday, 27 October, will address this.  Attendees will be drawn from key stakeholders whose interaction will create a cross-sectoral, highly relevant and dynamic discussion forum. 

Legislative discussion: Implications for effective care of the EU's in vitro diagnostics regulation (IVDR)

As mentioned earlier this week, a recent expert round table explored aspects of specific challenges to determine to what extent the implications of IVDR are fully understood – and the overwhelming conclusion was that many questions remain unanswered. For example, there is still no clear answer available as to what the requirements will be around matching a specific companion diagnostic test with a specific therapy. 

A further case from the expert panel  focused on changes in the emerging paradigm in a specific disease area - AML - due to the introduction of NGS, and exposed additional uncertainties over the impact of IVDR on which methods are used in clinical practice. Further questions remain on what the position of IVDR would be when comprehensive genomics profiling is used and an actionable mutation is identified outside the approved indication, and particularly if the companion diagnostic is paired with a specific drug in another disease setting. Another case looked at which testing methodologies would be acceptable under IVDR where a drug is approved but the companion diagnostic is not available at the time of launch 

Summary of downsides

Without an agreement from the other EU institution to the recent Commission proposal to IVDR, there is a risk that any niche – and not so niche – IVD medical tests will disappear. Participants in the recent expert roundtable reported that industry sources have already stated that some tests simply will not be available if the regime is enforced on the timings envisaged. "There will be real problems ahead,"the participant added: "We don't know what tests we will have available next year." 

Already, availability is uneven across Europe. And now it is apparent that awareness of the impending difficulties also varies widely from country to country, with a high perception of the risks in The Netherlands but still only a limited sense of urgency in Hungary.

In addition, companies that decide to seek national derogations for their products in order to maintain them on the market would be obliged to generate a tidal wave of paperwork that could overwhelm their own resources and create a logjam in national regulatory agencies, since there will be upwards of 20,000 products that will need certification for the first time. 

Inequity in access to tests will also be multiplied, since if manufacturers are obliged to seek country by country clearance they will inevitably prioritise bigger markets first, leaving smaller markets even further disadvantaged than they already are in provision. Other downsides are that the lack of adequate regulatory infrastructure, particularly insufficient capacity among notified bodies, will tend to limit competition, with the most established suppliers benefiting at the cost of diversity among smaller labs and companies and institutions.

Potential solutions

The most obvious – if not politically the most simple – solution to the predicament is to modify the legislation to provide for greater flexibility in its implementation as proposed by the Commission recently. There is some strong support for this approach: in May 2021 the European Parliament requested postponement for a year, and the June 2021 Council of health ministers requested ‘legislative action’ to address IVDR transition. This is widely considered to constitute a mandate for the European Commission to draft a proposal to amend IVDR, and there are hopes that such a proposal might indeed emerge in the early autumn.

However, this view is not universally shared, and within the EU there are powerful advocates of prompt implementation of the legislation on the deadlines set – including the European consumer organisation BEUC, and the Danish health minister, who has urged that tighter controls should be introduced rapidly to check the validity of Covid tests. There is discernible political momentum behind early implementation, reinforced by the administrative inertia that tends to militate against last-minute changes of direction.

Recommendations from the EAPM EXPERT PANEL

Solutions need to be decided and widely communicated as soon as possible to provide clarity and certainty to patients, healthcare systems and industry. Any solution must ensure that all IVDs can be certified and transition on time. Different solutions could work, so long as they ensure that a minimum viable infrastructure is in place before the certification deadline, but they must all cover all IVDs which need a notified body certificate. Only this way will it be possible to ensure no interruption to patients, hospitals, labs and health care professionals. 

With this in mind, the European Commission and the Medical Devices Coordination Group should designate a sufficient number of notified bodies and ensure that all elements and procedures needed to certify the various categories of IVDs are fully operational. This could allow for a mix of scenarios: postponement with expanded / longer grace periods for some categories, accompanied by phased transition, so as to ensure patient access and to allow innovation to continue.

Above all there is a crucial need to work together among all stakeholders to get a coherent message urgently through to policymakers – including the fact that at the time of writing, there are now only nine months to the legislation's deadline.

In other news....

Restrictions on the up in Czech Republic 

Mask requirements will be expanded and the amount of time that PCR and antigen tests are valid will be shortened, the Czech health ministry has announced, responding to the rising number of coronavirus cases. The Czech Republic is one of a number of Eastern European countries that is seeing a COVID-19 resurgence. It has vaccinated 57% of its population — well above Romania and Bulgaria, but lags behind Western European countries such as France, Spain and Italy.

Situation in UK ‘entirely predictable’

Rising coronavirus cases in the UK have come about largely as a result of the relaxation of almost all restrictions in July, several experts have said. Chris Dye, professor of epidemiology at the University of Oxford, said that the difference between the UK and the rest of Western Europe, is that Britain is “really slack on public health”. It was “entirely predictable”, said Deepti Gurdasani, an epidemiologist at Queen Mary University London. While doctors are calling for urgent reintroduction of measures such as mask-wearing, the British government has so far chosen to reject calls to implement so-called ‘Plan B’.

And that is all from EAPM for this week – don’t forget, you can register for the 27 October EAPM conference here and click on the link to view the agenda here. Stay safe, have an excellent weekend, see you next week.

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