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Drugs are not directly addressed in Europe's new legislation for chemicals. But they'll be affected, because chemicals are used in drug manufacturing.
Pharma companies are used to having to work hard to keep regulators happy, so dealing with FDA inspections and keeping tabs on side-effects of marketed medicines ensure that regulatory affairs departments remain busy. But now there's something else they're going to have to worry about in Europe—new chemicals legislation.
The legislation—Registration, Evaluation and Authorization of Chemicals (Reach)—is at the second-reading stage in the European Parliament, having undergone significant amendments since it was first introduced. It is designed to replace a sprawling array of more than 40 different pieces of legislation; a final agreement by the European Parliament is expected in the fall of this year.
Around 30,000 existing substances will have to be registered within an 11-year phase-in period. How much data is required will depend on how much of each chemical is produced, and whether they are dangerous, such as carcinogens, mutagens, or bioaccumulative chemicals.
Dangerous materials will have to undergo an authorization process. Although medicinal products will likely be exempt from the legislation, chemicals are involved in the manufacturing of those products, so Reach will have an impact on pharma. The industry, through its primary manufacturing operations, makes and uses chemicals that will fall under the scope of Reach, and others are involved in the formulation stage. Many more are purchased from outside suppliers.
The legislation in its original form would have proved extremely bureaucratic and burdensome for those making and using chemicals. In the best tradition of the European Union machine, compromises altered the proposals to enable a broad political agreement at the first reading in the European Parliament.
Even so, the industry is unhappy with the current wording of the authorization element, with trade body Cefic, the European Chemical Industry Council, saying it reflects a "conceptual misunderstanding" of how such dangerous substances are handled and used. And NGOs believe the EU is now missing a trick by watering down the legislation. EPHA Environment Network, for example, claims that the system as it stands will leave thousands of chemicals without basic toxicity data.
Pharma companies also are concerned. "[We] support the stated goals of the proposed regulation to protect the environment and human health," says Bertrand Castro, director of development chemistry at Sanofi-Aventis. "However, we oppose an approach to regulation that is too mechanistic, inflexible, and devoid of proper cost-benefit analysis, where the burden of compliance is disproportionate to the problem being addressed."
Trends toward outsourcing have left pharma companies heavily reliant on partners in the fine chemical industry to supply many of the intermediates and active ingredients they need to make their drug products. Castro is concerned that if Reach imposes onerous economic and administrative burdens on its suppliers, it may affect pharma companies' ability to procure such chemicals from them.
"The withdrawal of chemicals by manufacturers in our supply chain could affect availability of our starting materials, reagents, and solvents, and thus indirectly result in the loss of pharmaceutical products necessary to protect or enhance human health," Castro said.
Marketing authorizations specify manufacturing routes and suppliers of ingredients and intermediates. Once the authorization has been granted, making changes is extremely expensive and time consuming.
There is also concern that non-active substances used in drug products will, unintentionally, be dragged into the scope of the legislation. While active ingredients are definitely exempt, it is still unclear whether the essential inactive components of a formulation, such as excipients or propellants, will be covered.
Another issue is the need for animal testing. At a time when pharma is actively looking for ways to minimize the number of tests that are carried out on animals, Reach introduces a requirement for animal testing data on all chemicals made in quantities of more than a ton a year—many of which have been safely used in large quantities for decades. Currently, only "new" chemicals—those introduced after 1981—need testing. The amended version of the legislation takes this into account to some extent, by introducing mandatory data sharing for test results.
Discussions continue about the final wording of the regulation, and the industry is hoping that the end result proves practical and workable. "We hope that together we will be able to make the necessary changes," says Castro, "to reduce the burden of the regulation with a view to avoiding unduly bureaucratic and burdensome requirements."
Sarah Houlton, PhD, is Pharmaceutical Executive's global correspondent. She can be reached at email@example.com