Despite a decade-long build up, drugmakers are yet to wake up to the “no data, no market” mantra of the EC’s REACH legislation, according to SAFC’s marketing director Amanda Halford.
The pre-registration deadline, which allows companies to carry on importing a particular chemical while tests are carried out, expires on December 1. Drug and chemical firms failing to submit within this timeframe will be required to halt importation until full safety analysis is completed.
Halford explained that because active pharmaceutical ingredients (APIs) are exempt, pharmaceutical firms have been slow to realise the extent to which intermediates and chemicals used in drug production will be impacted by the European Commission’s (EC) legislation.
She cited a recent survey by PriceWaterHouseCooper, which forecast that up to 20 per cent of the chemicals available in Europe, will disappear under the new rules, and said that: “while the chemical industry is well informed, industries that use chemistry are not.”
Scientific exchange forum
Halford said that, in addition to continuing its work with the EC on drafting the latest REACH whitepaper, SAFC has started to offer its customers specific advice on preparing for the new rules. She explained that the firm was providing solutions and guidance based on the long-term relationships it has developed with industrial clients.
Halford also highlighted the Scientific Information Exchange Forums (SIEFs) as one of the processes likely to ease compliance. She explained that through the forums, which are due to become operational early next year, firms wishing to register the same chemical compound can share data and analysis work, significantly reducing development time and costs.
She cautioned however that certain difficulties, such as a reluctance among drug firms to share market sensitive, proprietary information within the SIEFs still needs to be overcome. Halford explained that this is particularly true of non-EU companies wishing to operate in the region.
Long term REACH picture unclear
Frank Wicks, SAFC’s president, told in-PharmaTechnologist that, in the long-term, the REACH regulations are likely to change. He predicted that in 10 years time, the cost of complying with the regulations as they are now will be prohibitive and speculated that: “the European Union would not want to damage overall competitiveness.”
Dr Wicks went on to say that it is important for pharmaceutical firms to plan for the future. He explained that drugmakers working with quantities of chemicals below the 1 tonne per year limit during development will need to consider how REACH will apply to them when they scale up production to commercial levels a decade or more down the line.
He also said that, based on his conversations with other industry CEOs, he anticipates that drug and chemical firms worldwide are likely to begin working together to reduce the cost of applying the regulations.