The CLP Regulation: Unintended Consequences for Compounding Pharmacies?

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1 The CLP Regulation: Unintended Consequences for Compounding Pharmacies? Andrea L. Hamilton McDermott Will & Emery/Stanbrook LLP Brussels 20 January Boston Brussels Chicago Düsseldorf Houston London Los Angeles Miami Milan Munich New York Orange County Rome San Diego Silicon Valley Washington, D.C. Strategic alliance with MWE China Law Offices (Shanghai) 2010 McDermott Will & Emery LLP. McDermott operates its practice through separate legal entities in each of the countries where it has offices. This communication may be considered attorney advertising. Previous results are not a guarantee of future outcome. The following legal entities are collectively referred to as "McDermott Will & Emery," "McDermott" or "the Firm": McDermott Will & Emery LLP, McDermott Will & Emery/ Stanbrook LLP, McDermott Will & Emery Rechtsanwälte Steuerberater LLP, MWE Steuerberatungsgesellschaft mbh, McDermott Will & Emery Studio Legale Associato and McDermott Will & Emery UK LLP. These entities coordinate their activities through service agreements. This communication may be considered advertising under the rules regulating the legal profession.

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3 Overview Could the CLP Regulation, 1272/2008, be interpreted as applying to compounding pharmacies?! Legal framework applicable to compounding pharmacies! Could the CLP Regulation potentially apply to compounding pharmacies?! Consequences and open questions! Conclusions and next steps

4 Legal framework applicable to compounding pharmacies! Primarily national; EU rules on medicinal products focus mainly on marketing and manufacturing authorisation! Pharmacists are generally regulated at the national level and are only marginally covered at the EU level! The EU coverage, however marginal, should be examined! In particular, the CLP Regulation, 1272/2008, could have significant practical consequences for compounding pharmacies

5 Could the CLP Regulation potentially apply to compounding pharmacies? (1)! Article 1.5(a) of the CLP Regulation contains an provision, exempting certain products from its purview! This Regulation shall not apply to substances and mixtures in the following forms which are in the finished state, intended for the final user:! (a) Medicinal products as defined in Directive 2001/83/EC! Directive 2001/83/EC relating to Medicinal Products for Human Use defines Medicinal products as:! (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human being; or! (b) Any substance of combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

6 Could the CLP Regulation potentially apply to compounding pharmacies? (2)! The CLP Regulation thus exempts medicinal products in their final state and intended for the final user! Compounding pharmacies supply medicinal products to patients and also supply each other with medicinal products and substances! E.g., in some Member States, such as Denmark and Finland, there is a trend toward centralisation of compounding hospital pharmacies! Since cross-supply among compounding pharmacies would technically not constitute a product for the final user (or potentially not in the final state ), the CLP Regulation exception could, in principle, not apply Compounding pharmacies could thus fall under the CLP Regulation when supplying each other, but not when supplying the same products to patients

7 Possible consequences! Compounding pharmacists could be considered downstream users or distributors within the CLP Regulation when they supply products to one another, but not when they supply patients! (Could also mean that the CLP Regulation imposes more rules on compounding pharmacies than the Medicinal Products Directive, from which CLP derives the definition of medicinal products in the Article 1.5 exception)! Since the CLP Regulation changes and expands the previous rules on hazardous products contained in the Dangerous Preparations Directive 1999/45/EEC, potentially creating many new obligations for compounding pharmacies in certain transactions! New liabilities?! Legal uncertainty?

8 Open questions! Precisely when is a compounding pharmacy subject to the CLP?! Is the line between patient and pharmacy supply always clear?! What additional liabilities does a compounding pharmacy face when its transactions are subject to the CLP?! Does this also affect underlying national laws obliging compounding pharmacies to comply with all applicable laws?! As a practical matter, were compounding pharmacies ever intended to be considered downstream users at all under the CLP?! Medicinal products are broadly exempted from the CLP Regulation! The quantities of substances are limited in comparison to mass production

9 Conclusions and next steps! Compounding pharmacies could be interpreted as falling within the purview of the CLP Regulation, at least with respect to certain transactions (i.e., cross-supply)! If the CLP applies, compounding pharmacies will face substantial additional obligations, possibly greater liability and potential uncertainty since the rules apply only to some sales! Next steps?! Would increased harmonisation of the rules applicable to compounding pharmacies remedy the problem? Improve legal certainty?! Should compounding pharmacy regulation occur solely at the national level?! Should the existing rules be refined?

10 Questions? Thank you