MEDICINES AND DEVICES:NOT SO MUCH APART ANYMORE

WHO Winter Meeting 20126 January 2012

Erik Vollebregtwww.axonadvocaten.nl

Developments

• Medical devices and medicinal products increasingly ‘compete’ for the same therapeutic indications

• Convergence between medical devices and medicinal products, e.g. • companion diagnostics• ATMP / device combinations• Traditional combination products

• First actual borderline case medicinal product / medical device now pending at European Court (C-219/11 Brain Products)

Demarcation

• Medical devices: medical purpose but principal intended action is not achieved by pharmacological, immunological or metabolic means

• Cosmetics: "target site" + intended main cosmetic function

• Food: any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans

• ATMPs: medicinal products that also meet the definition of gene/cell therapy or tissue engineered product

BorderLINE paradigm

• Guidance and application of law are based on binary criterion: yes or no

• Hierarchy clause in Directive 2001/83 diluted by EU court's emphasis on evidence based decision (Hecht Pharma and Commission/Spain cases)

• Result is a border 'area' in which science supporting mode of action may support either side of the border 'line'

Border areas

Food Medicaldevices

Cosmetics ATMPs

Pharma

Food Medicaldevices

Cosmetics ATMPs

Border areas

Definitely deviceDefinitely pharma

Devices

Pharma

Application problems• Hierarchy clause in Directive 2001/83 in case of doubt

• When is there doubt? Not if product is intended to have pharmacological effect then medicinal product by function (C-369/88 Delattre, C-112/89 Upjohn)

• Application must not lead to classification as medicinal product of substances which, while having an effect on the human body, do not significantly affect the metabolism and thus do not strictly modify the way in which it functions (C-319/05 Garlic Pills, C-140/07 Hecht Pharma, C-27/08 BIOS)

• Scope of application of the "presentation" criterion

• Too wide scope will include legitimate advertising for other than medicinal products

• One must be able to claim medical effect of medical device

Application problems

• No automatic application to classes of products; function of each product must be assessed on basis of state of art science (C-150/00 Commission/Austria, C-88/07 Commission/Spain)

• Function depends on pharmacological properties to the extent to which they can be established in the present state of scientific knowledge, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail (C-319/05 Garlic Pills, C-140/07 Hecht Pharma)

• No medicinal product if the product is incapable of appreciably restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action (C-140/07 Hecht Pharma, C-27/08 BIOS)

So what follows?• EU court says: decisions must be evidence-based and case-by-case

basis

• Authorities will struggle and still diverge absent EU level decision maker (as currently advocated in medical devices legislative review)

• Market parties will battle and baffle judges with science judges cannot understand; judges will use creative ways to dodge science

• EU Court Nycomed case for example• Unclear how the presentation criterion fits into this for borderline

cases

• Borderline products may have been overly forced into pharma regime by authorities and competitors, so counter movements

• Increased regulatory discussions with authorities about regulatory pathway for product

• Expected trend of rediscovery of border area products as medical devices

Thank you for your attention

Erik VollebregtAxon AdvocatenPiet Heinkade 1831019 HC AmsterdamT +31 88 650 6500F +31 88 650 6555M +31 6 47 180 683E erik.vollebregt@axonadvocaten.nlT @meddevlegalB http://medicaldeviceslegal.com