Berlin – At the symposium of the AG Pro Biosimilars in June 2023, experts from various fields warned of negative consequences immediately after the G-BA decision on the automatic substitution of parenterals. It favors the already evident trend that more and more biopharmaceuticals are being produced in Asia – also for cost reasons.
Panel 1: Substitution, security of supply and location: (How) does that fit together?”
dr Jasmina Kirchhoff from iW Cologne presented the study “Anyone who wants reshoring must prevent offshoring”, which she had carried out together with Prof. David Francas from Worms University. There is still a strong location in Europe. But this is already eroding. On the one hand, this has to do with the price policy of European countries, but also with state-controlled industrial policy in countries like China or India. If Europe wants to maintain a strong location and security of supply for biopharmaceuticals and biosimilars, it must be careful and not jeopardize its lead by focusing on costs.
Lars Lindemann, MdB, spokesman for pharmaceuticals of the FDP Bundestag party, made it clear that his party was quite critical of the automatic substitution. However, he was unable to assert himself in the parliamentary process. In the last few decades, generics have been all about pushing prices down. If this also happens with biosimilars, he can understand why manufacturers are withdrawing. “We have to start thinking in terms of healthcare,” says Lindemann. Security of supply also means producing medicines in Europe. But that also means higher prices. “We would have to spend more money here and I doubt that we will find a political majority for it.”
Walter Rohrer, Chairman of the Working Group Pro Biosimilars, made it clear that the industry was not about “subsidies”. Rather, the biosimilars are a healthy system that is now being endangered – unnecessarily – and thus risking massive consequences for the location and security of supply. “It is completely incomprehensible to me why politicians are triggering a development in biopharmaceuticals that they are currently trying to reverse in generics,” said Rohrer. “Don’t do that with the subsidy and you will see: the biosimilar competition will continue to generate savings.”
Would you like the lecture by Dr. See Jasmina Kirchhoff? Then click here. The recording of the 1st panel is available here. A summary (10 minutes) of the 1st panel is available here ready to download. The study by Dr. You will find Jasmina Kirchhoff and Prof. David Francas here.
Panel 2: Automatic substitution for parenterals – what should be considered now?”
In the discussion about the G-BA decision on the exchange of biopharmaceuticals in parenteral preparations, it became clear that there is still a lot of ambiguity about what is actually regulated.
“The G-BA decision raises more questions than it answers,” said dr Christopher Kirsch, Head of Market Access at Sandoz Germany. “For example, he leaves open which active ingredients he means when he declares them to be interchangeable. This causes huge problems in implementation. And the G-BA determines their interchangeability in places where this is not permitted at all – namely outside of discount agreements. This is not legitimized under social law and is therefore illegal”.
Also Christiane Müller, Managing Director, VZA eV, emphasized the lack of clarity in the decision, which poses major problems for pharmacies. Terms are not defined and pharmacists are left to their own devices in many places. Among other things, she called on the G-BA to draw up a specific list of active substances that can be exchanged. “Otherwise there is no legal certainty here,” says Müller.
Thomas Müller, Head of Department 1, BMG, admitted: “The clarity of the norms is not yet ideal.” He’ll take that with him. At the same time, he made it clear that he wanted to stick to automatic substitution. “The aim is to increase profitability. And we achieve that through discount agreements”. For him, biosimilar market shares of 90 percent do not mean that the profitability has been exhausted to the maximum – not even if a discount of up to 80 percent is already being granted.
dr André Breddemann, head of the prescribed services department at BARMER, asserted that he wanted to create clarity for pharmacies within the framework of contracts and to further develop the instrument of discount contracts. For his health insurance, these should become an instrument to ensure supply. “We went through a learning process with generics,” says Breddemann. “We’re not repeating the same story 1:1 with biosimilars and we’re not making the same mistakes again.”
That wanted Christopher Kirsch do not accept. There can be no safe way for him. Even if one insurance company proceeds with a sense of proportion and only concludes discount agreements for one active ingredient, another will certainly follow suit. Kirsch: “We are already under the spell of this development and can no longer counteract it. The decision of the G-BA is a “sick leave for a healthy system”. The Ministry of Health must under no circumstances wave it through and must object to the unclear points.
Would you like to see the entire 2nd panel? Then click here. A summary of the 2nd panel (20 minutes) is available here ready to download.
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There were technical problems with the transmission of the symposium on June 21, 2023. We apologize for this and thank you for your patience.
The AG Pro Biosimilars represents the interests of biosimilar companies in Germany. It is open to all companies that develop, manufacture and supply biosimilars. The working group under the umbrella of Pro Generika eV is committed to providing patients with needs-based access to modern biopharmaceutical drug therapies, affordable care and fair and sustainable competitive conditions.