When Stada’s head of western Europe and Germany, Stephan Eder, was recently named as the new president of industry association Medicines for Europe, he set out his three key priorities as ensuring sustainable market policies for the off-patent sector, supporting manufacturing in Europe, and building a “strong environmental, social and governance agenda for medicines with patient access at its core.”
Now, in an exclusive interview with Generics Bulletin, Eder delves deeper into what sustainability looks like for the generics, biosimilars and value-added medicines industry, as well as the importance of local manufacturing in the region, the ongoing success of biosimilars and how the industry is dealing with challenges such as the EU’s urban waste water treatment directive.
At the outset, Eder is clear to credit former president Elisabeth Stampa “for the great work that she has done” as president. “And I’m also very pleased that she continues as vice president, with [Polpharma CEO] Markus Sieger,” he highlighted. “So we have great continuity in this respect, and what we are going to focus on for the next few years is not in any way a break with the past, but very much a continuation.”
An ‘Indispensable Pillar Of Healthcare’
Describing the off-patent industry as an “indispensable pillar of healthcare in Europe,” Eder was clear that “without the generics and biosimilars industry, there would be no healthcare in Europe.” And “the value and the savings also that we drive are huge.” But while this was “a great starting place” for the industry, he said, “at the same time, of course every industry is facing opportunities and challenges.”
“Firstly we would like to focus on having sustainable market policies that place value at the center and go on to criteria beyond price. Then secondly, that we have a vibrant off-patent manufacturing sector in Europe, meaning in the EU but also in candidate countries. And of course also we would like to see manufacturing in the UK.” And then thirdly, “that we really drive and advance our ESG agenda while at the same time always ensuring that it has patient access at its heart.”
In terms of sustainability and criteria that go beyond price, Eder highlighted that initial attempts to factor non-price criteria into procurement processes had been seen in the Nordics, as well as in the UK where ESG criteria were being taken into account. But what Medicines for Europe really wanted to see, he indicated, was a wider recognition of the importance of a diverse supply chain.
“I think as COVID and the crisis afterwards – or the challenges, in terms of supply shortages afterwards – have shown that a robust and partially redundant supply chain, so that you have different supply chains, is key to securing medicine supply,” he set out.
Country-focused activities in this area have included pushing for mandatory three-slot tenders in Germany instead of single-slot tenders. And more broadly, “the market policies, as well as an EU industrial policy that advances European manufacturing, are both central to the critical medicines alliance and the Critical Medicines Act that shall become reality very, very soon. And we are very much active in this respect.”
“I think in Europe we have really a manufacturing sector that we can be proud of.”
Meanwhile, on manufacturing Eder highlighted that Europe boasted a “vibrant” manufacturing environment. “We have over 400 sites and we do not only have active pharmaceutical ingredient sites and finished-dose formulation sites, we also have [both] small molecule and biologic sites. So I think in Europe we have really a manufacturing sector that we can be proud of.”
However, “at the same time, what we would like to see is that EU state aid rules shall be modified,” he suggested. “In essence at present it’s only for innovation investment into manufacturing,” he noted, whereas what Medicines for Europe would like to see is “that we could also be eligible … for, say, process improvement for additional digitization, automation or also for employing novel and environmentally even friendlier manufacturing techniques. Because in the end this will all advance not only manufacturing, but of course also the green agenda of the EU.”
On the ESG side, Medicines for Europe has also been vocal in advocating the introduction of an electronic patient information leaflet, or e-PIL, to replace paper leaflets. “We believe in the advantages of the electronic patient information leaflet,” Eder said, “for various reasons.”
“If you, say, live in France and you have access to a patient leaflet in French, but you might not be fully fluent in French, then you do not get from the leaflet what you actually want,” he suggested. Whereas “if you have a QR code, you could have it in different languages, you could have it in simplified languages, you could just have the abbreviated information available for what patients need ... so I think it drives also safety and greater access.”
Meanwhile, “it allows of course for much more frequent updates. So if you have new safety signals, you could implement them immediately without the need for potential recalls.” Whereas “if new safety information is added to the [paper] leaflet, the product itself has not changed, just the leaflet – but still you might need to recall and repack. So I think it’s a great efficient use of this.”
“The cost impact that the urban waste water treatment directive might have was probably not fully understood and assessed.”
Moving on to discuss the urban waste water treatment directive – which Medicines for Europe has previously warned could take a severe financial toll on the off-patent industry, potentially leading to shortages – Eder was clear that the issue was “not about medicines production, it’s about medicines consumption,” suggesting that “frequently, I think in the public discourse, this might be confused.”
“Of course we want medicines production to be as green as possible,” he acknowledged, “but at the same time, medicines consumption, it’s driven by a need. So if a patient who suffers from diabetes takes medicine, of course there’s a medical reason for this.”
“What we see as our challenge is that the directive is on the one hand, in its scope, discriminatory – because it singles out in the end, pharma and the cosmetics industry and, not other industries where the consumption of its products also contributes to wastewater – and also disproportionate, because the cost impact that it might have was probably not fully understood and assessed. And this might indeed then have an impact on the cost of medicines.”
“Just give you one example, the estimates for Germany from the communal wastewater treatment sector is that it could cost up to €10bn ($10.3bn) and then another €1bn-€2bn a year, the treatment. If you compare this to less than €3bn annual generics turnover for publicly insured patients, well there is a certain disproportionality.”
“So what can be done? We are working with the Commission, we are working with the member states to assess, to understand the impact – and also then in the implementation of the directive to work towards ensuring that the critical medicines that are potentially impacted by this will not be impacted and will still be available for patients.”
Biosimilars ‘A Real Success Story’ In Europe
Turning to biosimilars, Eder was effusive in describing the sector as “really a success story since its inception, well more than 15 years ago.”
“What we see is indeed that biosimilars have very much arrived, in the sense that physicians and patients very much rely on biosimilars,” he said. “And not only have we been able to lower treatment costs – €10bn in 2023 was saved through biosimilars – but it’ll dramatically increase of course access.”
“In many, many member states now we see biosimilar adoption rates, penetration rates, up to say 90%, 95%,” he pointed out. And “if you look at patent expiries going forward,” biologics “have huge patent expires in the next few years, ranging between €3bn and up to €17bn annually from 2025 to 2030. And that is of course a huge pipeline, a huge pool of potential biosimilars.”
Noting however a change in the landscape, in terms of the innovator products being targeted by biosimilars developers, Eder observed that “it’s not any more that you have one big blockbuster that takes it all, but you have smaller products going also towards more niche indications. And consequently, it’s also of course, smaller markets.”
As a result, “what we see is less development candidates in the pipeline”, with “especially smaller biosimilar biologic products that do not see a sufficient number, or no biosimilar development candidate at all – because of course development costs continue to be the same, nearly, regardless of the size of the market.”
“If the addressable market is lower, then of course the risk-reward profile is a different one,” he conceded. “And that is definitely something that we have very much on the radar and that we want to address.”
Asked whether recent moves from the European Medicines Agency – to explore the elimination of comparative efficacy trials as standard for biosimilar filings – provided some optimism in terms of potentially reducing development costs, Eder responded “Exactly. Because then, in the equation, this would lower the development cost and it could potentially bring more biosimilar candidates to the market.”
And on European value added medicines – an area recently covered by Generics Bulletin at length in an interview with Medicines for Europe sector chair James Burt – Eder affirmed that the association was continuing to push for a broader recognition of value added medicines as part of the EU pharma legislation review, “because we do indeed believe that this plays an important role in advancing treatment options you have for niche indications or new formulations, also new indications.”
Critical Medicines Act Is On The Horizon
Finally, asked about upcoming milestones for the off-patent industry in Europe, Eder said “two milestones that we expect this year is, one, the Critical Medicines Act, which will be swiftly completed. And we are actively contributing to this, and we are very encouraged by the work that we see there.” And secondly, “the finalization of the pharma legislation.”
Highlighting industry objectives such as a stronger Bolar mechanism as well as tackling originator evergreening strategies and abuse of aspects such as divisional patents, Eder said that “for us, the principle is always: look, clear patents are important and we need to have a balance between strong patent protection and access to medicines.” And Medicines for Europe wanted to “work with the competent authorities to make sure that this overarching principle is adhered to.”
“In the end, we believe this is also a symbiotic system,” he said, “because it’s not the patent that drives innovation, but it’s the expiry of the patent and the resulting competition that comes afterwards that drives continuous innovation.”
“So we see ourselves very much part of this ecosystem – but our principle is that once the patent expires, the next day, generics or biosimilars need to be on the market.”
