Document 5omNDqbL2kM0ZrgpVy18OL3N
Ad-Hoc open BCR Meeting 28. March 2023 FPS premises
Pharma in Belgium
o R&D investment represents the 2nd largest share of GDP (~0.8% of its GDP in 2019) among EU countries.
o Manufacturing footprint is unique in its size; BE is #3 in biopharma exports per capita in Europe (~ 56 B exported in 2020) with an upward trend (CAGR +13.1% from 2015-2019).
o Largest employer in BE (more than 125,000 total FTEs in 2020).
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the innovative pharmaceutical industry operating in Europe.
Through its direct membership of 37 national associations and 38 leading pharmaceutical companies, with a growing number of small and medium-sized enterprises (SMEs). EFPIA is the voice on the EU scene of 1,900 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world.
1
Remarks on the Scope / Definition of PFAS
Definition Proposed in the Draft Restriction Broadened to include fluoropolymers and molecules with low F content, while the term ,,PFAS" is maintained
No international alignment Derogations are embedded in the PFAS definition, which adds complexity
What Changes might be Helpful Alignment with other regions, such as the U.S. EPA definition Exempt non-persistent PFAS by derogation and list them in an Annex
(PFAS) includes chemicals that contain at least one of these three structures (in CCL5): (1) R-(CF2)-CF(R)R, where both the CF2 and CF moieties are saturated carbons, and none of the R groups can be hydrogen. (2) R-CF2OCF2-R, where both the CF2 moieties are saturated carbons, and none of the R groups can be hydrogen. (3) CF3C(CF3)RR, where all the carbons are saturated, and none of the R groups can be hydrogen.
Per- and polyfluoroalkyl substances (PFASs) defined as: Any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (CF2-) carbon atom (without any H/Cl/Br/I attached to it). A substance that only contains the following structural elements is excluded from the scope of the restriction: CF3-X or X-CF2-X', where X = -OR or -NRR' and X' = methyl (CH3), methylene (-CH2-), an aromatic group, a carbonyl group (-C(O)-), -OR'', -SR'' or -NR''R'''; and where R/R'/R''/R''' is a hydrogen (-H), methyl (-CH3), methylene (-CH2-), an aromatic group or a carbonyl group (-C(O)-).
2
Restriction Impact on the Pharmaceutical Product
Other Ingredients
Raw Materials
Active Substance
Final Product
Not Derogated
Not Derogated Derogated
Not Derogated
Mitigation: nonEU manufacture
Mitigation: non-EU Development and Clinical
Testing
Development Not Derogated
No mitigation possible.
Conflict with existing market authorisations
Time-unlimited derogations are needed to keep manufacturing and development in the EU.
3
Restriction Impact on Pharmaceutical Manufacturing
process chemicals (e.g. TFA in biopharma)
Time-limited derogations are missing and ignore regulatory re-submission timelines.
Cannot be substituted
Use sectors not
addressed are not derogated
Cannot be substituted
Filter ,,textiles", water and oil repellent (5 e.)
Food contact materials
(6 a.)
Specific Derogations
(6 b..n.)
F-Gas Conflicts
Other fluoropolymers, e.g. ETFE
PCTFE 12y (6 l.)
4
Summary of Challenges
Time-unlimited derogations For desired molecules, only a time-unlimited derogation is applicable. This applies to active ingredients, raw materials (intermediates) required for manufacture, excipients including propellants, and any development products (PPORD)
Time limited derogations Derogations apply to substances, uses, products, properties, industries, or combinations thereof with no visible systematic. Applications are missing, terminology is undefined. The timelines ignore regulatory efforts, which in pharma take 10 years+.
Going from Zero to Ban A complete mapping of PFAS uses is impossible, as no disclosure, labeling or registration requirement exists yet, and many applicants are not aware and have no means to verify which materials are PFAS
5
What Changes might be Helpful
Clear legal structure No double regulation of products already positive or negative listed (authorised or restricted). This applies to pharmaceuticals for humans and animals, agricultural products, biocides, F-Gas and REACH restrictions or authorisations.
Reduced Complexity Systematic derogations (e.g. fluoropolymers in industrial use, under inventory and waste management requirements)
Flexible Timelines For difficult substitutions and inclusion of regulatory re-submission, timelines should be flexible (unlimited but reviewed, or 12 years with an opt-out clause)
Focus on Emission Reduction Focus on emission reduction. Inventory and waste management must be in place when a substance is banned, otherwise emissions from waste streams will increase.
6