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Monday 18 October 2010

When will the "suitable opportunity" arise for changing an obsolete definition?

Let's all be pen-friends
with the European Commission
The SPC Blog thanks international patent consultant Dr Herwig von Morzé for sight of some interest and relevant correspondence between him and Oliver Vahhelyi on behalf of the European Commission (DG Internal Market and Services).

The background is as follows: since the consolidated text of Regulation 469/2009 of 6 May 2009 concerning the creation of a supplementary protection certificate for medicinal products (codified version, replacing Council Regulation 1768/92 of 18 June 1992) still includes the now obsolete definition of "medicinal product" and requires amendment incorporating the new definition, Dr von Morzé wrote to the Commission as follows:
"The above-identified consolidated Regulation at least in the version available to me which was published in OJEU 16.6.2009 L152/1-L 152/10 requires revision of the definition of ‘medicinal product’ in Art. 1(a). The new definition of ‘medicinal product’ in Art. 1(2) of Directive 2001/83/EC as amended by Directive 2004/27/EC published 28.11.2004 in OJ L-311, pages 67-128 reads as follows:

‘2. Medicinal product:
(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or 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.’

As to the significance of the new definition please refer to Recital 7 of Directive 2004/27/EC.

Article 1(a) of Regulation (EC) No. 469/2004 still recites the previous, somewhat vague definition of ‘medicinal product’ which has been superseded by the new definition clarifying which actions exerted by the active substances of a medicinal product would be ‘restoring, correcting or modifying physiological functions’ (see the clause in bold above) .

The Hecht-Pharma GmbH judgment of the European Court of Justice C-140/07 of 15 January 2009 succinctly explains the significance of the expansion and the clarification achieved by the new definition:

‘33 As is apparent from recital 7 in the preamble thereto, the purpose of the amendments made by Directive 2004/27 to the definition of a medicinal product is to take account of the emergence of new therapies and of the growing number of so-called ‘borderline’ products. Also, in order to avoid doubts as to the applicable rules, the definition was made more precise and now specifies the type of action – pharmacological, immunological or metabolic – which a medicinal product must exert with a view to restoring, correcting or modifying human physiological functions.’

It must be assumed that the provisions of Regulation (EC) No. 469/2009/EC are set out to apply to all medicinal products within the ambit of the new definition. Regulatory concepts are not only key factors for administering and interpreting the Regulation but also must be incorporated in the codified Regulation in the version applicable as of the date of its codification to avoid uncertainty, improper limitations of its scope and unnecessary litigation.

I would be most grateful for your comments and would like to know which action would be taken to revise the definition".
for the European Commission (DG Internal Market and Services), Oliver Vahhelyi has responded as follows:
"Regulation (EC) 469/2009 indeed still uses the definition of medicinal products of Directive (EC) 2001/83 prior to the amendments made in 2004 by Directive (EC) 2004/27 of 31 March 2004.

We will consider introducing the definition of medicinal products of Directive (EC) 2001/83 as amended into Regulation (EC) 469/2009 when the most suitable opportunity arises to make such a technical adjustment.

I hope this information is useful to you".
"When the most suitable opportunity arises" is anyone's guess.  Readers' suggestions as to when we might see this amendment are welcomed.


Anonymous said...

But I unaderstand the new definition will not cover the case of a combination of a device loaded with a drug.

Herwig von Morzé said...

While this comment does not say it, it implies that a combination of a device loaded with a drug is not eligible for SPC protection.

However, under Art. 1 of Directive 93/42/EEC (Definitions, scope) it is already stated:

"Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 2001/83/EC, that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.

If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by Directive 2001/83/EC. The relevant essential requirements of Annex I to this Directive shall apply as far as safety and performance-related device features are concerned."

One should assume that at least the non-reusable medicinal product should be eligible for SPC protection because it would have been approved pursuant to Directive 2001/83/EC. However, any comments in this regard would very much be appreciated.