Les entreprises du médicament
Leem
Le Leem est l’organisation professionnelle qui fédère et représente les entreprises du médicament présentes en France.
ID: 04029409214-45
Lobbying Activity
Response to REACH Regulation - Annex XIV
14 Oct 2016
The Leem represents the Pharma industry in France and is the voice of 270 companies, which represents more than 98% of the total turnover in France (53 billion in 2015) and 224 manufacturing plants implantation.
The inclusion of Triton X-100 in Annex XIV of REACH regulation would have negative consequences on the pharmaceutical industry in Europe and in France and would not be the best option to achieve the aims of REACH while protecting the safety of patients and competitiveness of our industry.
Indeed, as regards patient safety, Triton X-100 is used for viral inactivation and to remove protein impurities from biotech medicinal products and is today the most robust pathogen VI method is use. The replacement of Triton X-100 by another product would lead to a necessary assessment by the EMA and place pressure on the supply on the concerned medicines in case the authorization to use another product would not be granted at the expiry date of use of Triton X-100. Indeed, amendments to pharma Marketing Authorizations and revalidation of manufacturing processes at facilities previously approved by EMA and other Medical regulatory authorities will be required.
The manufacturing of API follows strict rules aimed at managing risks towards workers, patients and the environment. Substituting Triton X-100, while requiring additional regulatory burden, would not grant benefits in security and patient safety.
Moreover, the burden of any additional regulatory rules would have great consequences on the R&D and manufacture of medicines within EU. Today, Pharmaceutical manufacturing is a key part of EU’s industry and therefore needs regulatory predictability to support long-term investments in facilities in EU. Adding Triton X-100 to Annex XIV would be a disincentive to long-term investment in EU manufacturing facilities and lead to major consequences to competitiveness of the EU and to Pharma companies which could decide to invest outside EU. No decision should be made without a full impact assessment on the use of Triton X-100 in biopharmaceutical manufacturing.
For those reasons, the French association representing the pharmaceutical industry in France calls for the non-inclusion of Triton X-100 from Annex XIV, and/or calls upon official authorities to find feasible and concrete solutions which will include patient safety, self-sufficiency in health, and excellence of manufacturing and medical research in Europe.
Read full responseMeeting with Fabien Dell (Cabinet of Commissioner Pierre Moscovici)
30 Sept 2015 · le plan Juncker