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Three Pillars Must Support Value Added Medicines In EU

Medicines For Europe Wants To ‘Level The Playing Field’ With US

Executive Summary

Medicines for Europe has called for fresh efforts to bolster the value added medicines sector and “level the playing field” with the US and its 505(b)(2) pathway, launching a new report setting out the three key areas in which greater EU action is needed.

Three key recommendations to support the development of the value added medicines sector in Europe have been set out by local off-patent industry association Medicines for Europe, in a new white paper that urges the EU to take concrete action to create an environment in which innovation around known molecules can flourish.

Value added medicines typically innovate around known drugs through repositioning medicines for different indications, reformulating them in a way that offers benefits, or combining them in new ways to deliver therapy, including via innovative technology that may incorporate digital components.

In its white paper, Medicines for Europe insists that “value added medicines should be recognized as a separate group of medicines in EU legislation, linking approval procedures, innovation frameworks and reimbursement processes to create an ecosystem that delivers better health to patients, solutions for healthcare systems and fair returns on R&D investments.”

“Gaps in the pharmaceutical legislation must be addressed to support off-patent innovation,” Medicines for Europe urges. The association has called for “the establishment of a new, simplified regulatory pathway for value added medicines, defined under a new Article 10.7 of the EU Directive 2001/83/EC, and built on three pillars.”

These are to design a fit-for-purpose regulatory framework that will enable clarity early in the development of value added medicines; to recognize value added medicines as a category of innovation with “proportionate incentives” such as a proposed four-year period of date exclusivity; and to recognize and define value for European healthcare systems by continuously shaping pricing and reimbursement rules to adequately assess continuous innovation.

US 505(b)(2) Pathway Offers Clearer Framework And Incentives

As part of its report, Medicines for Europe has drawn sharp comparisons between the EU and the US with its 505(b)(2) hybrid pathway for value added medicines, highlighting the need for Europe to “level the playing field” with the US market.

“The Value Added medicines innovation ecosystem in Europe markedly contrasts with that in the US”, the white paper notes, “which already, today, has a flourishing value added medicines segment based on its framework legislation that encourages innovation on off-patent molecules.”

Despite the “affordable and sustainable” nature of value added medicines, the association says the absence of a designated pathway in Europe is discouraging development, “in stark contrast to the US system, which has a clear framework to support patient-centered innovation.”

The 505(b)(2) pathway “offers a clear framework for companies to invest in innovation, for payers to recognise its value and for patients and prescribers to have access to better treatments,” the association believes. But the absence of a “cohesive and unique” regulatory framework for value added medicines in Europe “acts to the detriment of patients and healthcare professionals across the continent.”

“Our policy framework must catch up and support continuous innovation on off-patent medicines,” the association insists.

“The outbreak of COVID-19 in Europe highlighted the urgency to support value added medicines”

Moreover, Medicines for Europe suggested, “the outbreak of COVID-19 in Europe highlighted the urgency to support value added medicines,” given that “off-patent, repurposed medicines are among the few treatment options for critically ill COVID patients.” (Also see "Dexamethasone Shows Potential Of Repurposed Generics Against COVID-19" - Generics Bulletin, 18 Jun, 2020.)

“Successful repurposing provided access to affordable medicines such as dexamethasone to reduce fatalities in hospitalized COVID-19 patients,” the association pointed out. And “value added innovation also optimized healthcare resources by offering formulations of medicines that enabled patients to receive appropriate care at home, while not being exposed to the risk of contracting COVID-19, thereby relieving much needed hospital resources.”

“Never has the importance of value added medicines been more evident than during COVID-19,” concurred Medicines for Europe president Christoph Stoller. “Off-patent medicines were investigated and scientifically validated for new indications so that they could be used on critically ill COVID-19 patients and continue to be one of the very few lifelines for hospitals.”

“Additionally, the significant impact of the pandemic on non-COVID-19 patients cannot be underestimated and has demonstrated the need for a shift toward home care delivery, which can be supported by the combination of known molecules with digital technologies. Europe must develop a framework that supports this kind of innovation in the off-patent sector for all patients and disease areas.”

“Value added medicines don’t fit in the framework today, and we need dialog and action to fix that.”

Speaking at a Medicines for Europe webinar earlier today, the association’s sector chair, Arun Narayan of Viatris, said “this last year has more than ever demonstrated the continuing need” for value added medicines, especially in the context of the pandemic.

But with the framework in Europe “a far cry and markedly different” from the US, he said, much more effort was needed to enable the EU to become “a much bigger stakeholder in this area.”

On the association’s first pillar of creating a clear regulatory framework for value added medicines, Narayan said that, despite progress being made in some individual countries such as Belgium (Also see "Belgian body praises regulatory overhaul" - Generics Bulletin, 18 May, 2018.), there was still a lack of European-level action on the subject, with “different countries taking different approaches at different points in time.”

On the need for incentives to drive innovation around known molecules, he observed that “we all know that value added medicines are more complex, more expensive, take longer to develop and take a higher risk” than traditional generics – but “all these factors are not considered when it comes to finding incentives to develop value added medicines.”

And on the need to recognize and define value for healthcare systems, he noted that “in many cases, value added medicines are categorized along with generic medicines.”

“All these factors demonstrate that there is a gap,” Narayan insisted. “Value added medicines don’t fit in the framework today, and we need dialog and action to fix that.”

Whereas “the US has recognized the importance of off-patent innovation for the most challenging chronic diseases like cancer, respiratory conditions and antimicrobial resistance,” Narayan lamented that “Europe drastically lags behind the US in terms of supporting value added medicines.”

“Rather than stifling this innovation, the US has facilitated it with a dedicated regulatory pathway,” he pointed out. Therefore, a “fit for purpose legal framework” was needed under the EU Pharma Strategy to “put Europe at the center of continuous innovation on off-patent medicines.” (Also see "EU Pharma Strategy Will Remove Barriers And Bolster Competition" - Generics Bulletin, 25 Nov, 2020.)

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