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SPC waiver
This page shows the latest SPC waiver news and features for those working in and with pharma, biotech and healthcare.
Who's calling the shots in European healthcare?
Another major controversy was the introduction of a new SPC waiver, now introduced despite staunch opposition from pharma, plus questions about the future direction of the European Medicines Agency, newly relocated ... PME: A number of stakeholders say
Latest news
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Von der Leyen elected new European Commission president
On 1 July, a new supplementary protection certificate (SPC) manufacturing waiver was introduced, relaxing the regulations governing the manufacturing of generics and biosimilars in Europe.
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Industry aghast as EU Parliament backs biosimilar rule change
Our industry is extremely concerned that the proposal for the SPC manufacturing waiver will put patient access to medical innovation, highly killed jobs and investment at risk,” writes Oschmann. ... MfE called yesterday however for the European Council,
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Europe closer to biosimilar rule change, despite fierce resistance from pharma
Those supporting the changes say EFPIA’s claims don’t make sense – as the waiver doesn’t reduce any intellectual property protection, or curtail the SPC period. ... The SPC waiver is just one of the big issue for EFPIA in 2019, which says Europe
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Pharma sees European generics export plan as anti-innovation
The European Commission is now proposing what it calls a 'targeted amendment' to EU intellectual property (IP) rights, a so-called 'export manufacturing waiver' to Supplementary Protection Certificates. ... EFPIA’s experts say the plans to introduce an
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