a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriateThis Kat understands this to be the majority view around Europe, but that there are some conflicting cases in the Netherlands and Germany where the assessment processes were held to be equivalent and SPCs were allowed. The Decision is dated 31 March and is not yet apparently posted to BAILII, but the summary on the IPO website is excellent, and seems worth reproducing in full:
EC Design Examination Certificate No. G7 02 05 16178 063 was filed in support of SPC application SPC/GB/07/043 for “Platelet preparation obtainable by addition, and subsequent photoactivation, of amotosalen or its salt, to a suspension of platelets in plasma”. EC Design Examination Certificate No. G7 06 09 60562 004 was filed in support of SPC application SPC/GB/07/044 for “Platelet preparation obtainable by addition to plasma, and photoactivation, of amotosalen or its salt”. These EC Design Examination Certificates relate to medical devices that meet the criteria of Article 1(4) of Directive 93/42/EEC because they relate to a device that incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product and which acts upon the body with action ancillary to that of the device. As a consequence, they fall within class III medical devices and the safety, quality and usefulness of the substance must be verified, taking account of the intended purpose of the device, by analogy with the appropriate methods specified in the medicinal products legislation (Directive 2001/83/EC). Class III devices have the highest risk potential in terms of the vulnerability of the human body (taking account of the potential risks associated with the technical design and manufacture of the device). Explicit prior authorization with regard to conformity is required for such devices to be placed on the market. As a consequence of the need to assess the substance as part of the assessment of the device overall, the applicant argued that these EC Design Examination Certificates can, as a consequence, be considered to meet the requirements of Art 3(b) of the SPC regulation, i.e. they represent a valid authorization to place, on the market as a medicinal product, the product for which an SPC has been applied for.
The hearing officer reviewed the SPC regulation and the relevant parts of the medical devices and medicinal products directives. He took account of the purpose of both codes, the means by which medicinal products and medical devices deliver their principle mode of action, and the actual performance that is being assessed under both codes. He concluded that the assessment carried out in relation to the substance, i.e. the safety, quality and usefulness of the substance, when considered in light of the means by which the medical device delivers its action and considering the process by which a device is approved, including the roles of notified bodies and competent bodies, means that the conformity assessment procedure for a class III medical device is not the same as or equivalent to the process carried out to authorise a medicinal product for human use.
As a consequence, the SPC applications were found not to meet the requirements of Article 3(b) and were rejected under Article 10(2) of the SPC Regulation.