Medicines threatened
REACH could leave drug companies without intermediates, Cath O'Driscoll reports
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 Europe’s proposed new chemicals legislation, REACH (the registration,
evaluation and authorisation of chemicals), could potentially disrupt the supply
of important medicines and push up drug prices, industry insiders say.
The legislation, which could come into force in April 2007, poses a serious
threat to supplies of large numbers of intermediates and raw materials used
in drug manufacture, David Vosvenieks, REACH issue manager at AstraZeneca, told
an SCI meeting earlier this month.
Vosvenieks added that two companies supplying important intermediates required
for two AstraZeneca drugs have warned they may no longer be able to guarantee
supply.
‘While the possibility of this happening has always been on our radar,
this has come as a rude awakening,’ Vosvenieks said.
A spokesman for Pfizer, the world’s largest pharmaceutical company, admitted
the company was also in discussions with suppliers over REACH, but declined
to say whether any particular products were affected.
GlaxoSmithKline is also reviewing suppliers, said spokesman Stephen Rose. But,
he added: ‘To date we have not found anybody that has an issue that would
cause us a problem from the proposed REACH legislation.’
Losing suppliers has huge implications. They are strategic partners, rigorously
audited by companies’ global external sourcing teams to ensure their manufacturing
assets are safe, that they conform to health and safety requirements and that
they are using the right technology.
‘Finding a new supplier would be very much a last resort, and would potentially
bring extra costs,’ Vosvenieks said.
A change in supplier would mean resubmitting a drug for evaluation by regulatory
authorities. Substitute materials or intermediates would have different, albeit
very slightly, impurity profiles from the original substance and would therefore
need to be considered by the regulators.
A spokesperson at UK regulator, the Medicines and Healthcare Regulatory Authority,
confirmed: ‘In the event that a company is unable to use the same solvent
or agent in our authorised dossier, and has to use a substitute, the manufacturer
would have to submit a variation for authorisation.’ Depending on the complexity
of the change, reauthorisation could take 30 to 60 days, he added.
A lot of drug manufacture is driven by demand to cut down on costs, according
to Vosvenieks. This means some that drug companies may not have sufficient stockpiles
to see them through the reauthorisation period. If the reauthorisation process
is not straightforward, or sufficient supplies are not available to cover demand
over this time, in the worst-case scenario this could mean a delay with restarting
supply.
Active pharmaceutical ingredients (APIs) are largely exempt from REACH, but
many of the solvents and intermediates involved in the manufacture of the final
drug formulation are not. This is especially true of chemicals used in applications
outside of pharmaceuticals, Vosvenieks said, since these compounds may not qualify
for the usual lighter or ‘postcard’ registration requirements agreed
for other pharmaceutical intermediates.
The main chemicals affected will be hazardous chemicals, such as carcinogens
or mutagens, which, along with high volume chemicals, are given the highest
priority under REACH. ‘Such compounds are used in roughly 5-10% of drug
syntheses,’ he said.
Many of the smaller or more specialist firms producing them may lack the resources
to comply with REACH. ‘If suppliers can’t justify the cost of supporting
a product because of costs, this could lead to one supplier only for a particular
product, which could also drive up raw material costs. Or it could push manufacture
out of the EU,’ said Melvyn Whyte, managing director of Whyte Chemicals.
For pharmaceutical customers, several options are available: stepping in to
share the burden of compliance, outsourcing to a different, possibly overseas,
supplier, or manufacturing in-house. Longer term, companies could relocate manufacturing
so APIs are created outside of the EU, avoiding REACH altogether.
Industry bodies contacted by C&I seemed unaware of the problems.
The European Federation of Pharmaceutical Industries and Associations has an
expert body to monitor the impact of REACH. But spokesperson Christophe de Catallay
said, ‘Seen from a broader perspective, REACH hasn’t reached the top
of our agenda yet.’
Association of the British Pharmaceutical Industry spokesman Richard Ley pointed
out that problems could be even further back in the supply chain.
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