This document discusses the increasing convergence between medical devices and medicinal products. Some key points: - Medical devices and drugs are increasingly competing to treat the same conditions. Products like companion diagnostics and advanced therapy medical products combine features of drugs and devices. - The legal definitions of drugs, devices, cosmetics and foods are based on binary criteria but the scientific realities exist on a spectrum, making classification difficult. - Borderline cases are challenging the traditional drug/device divide and court decisions emphasize evidence-based classification on a case-by-case basis rather than rigid application of legal definitions. - Unclear boundaries could lead to disputes between regulators and companies over the proper regulatory pathway for innovative products that

1. MEDICINES AND
DEVICES:
NOT SO MUCH
APART ANYMORE
WHO Winter Meeting Erik Vollebregt
2012 www.axonadvocaten.nl
6 January 2012

2. 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)

3. 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

4. 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'

5. Border areas
Food
Food Medical
Medical
devices
devices
Pharma
Cosmetics
Cosmetics ATMPs
ATMPs

6. Border areas
Devices
Definitely
pharma Definitely device
Pharma

7. 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

8. 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)

9. 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

10. Thank you for your attention
Erik Vollebregt
Axon Advocaten
Piet Heinkade 183
1019 HC Amsterdam
T +31 88 650 6500
F +31 88 650 6555
M +31 6 47 180 683
E erik.vollebregt@axonadvocaten.nl
T @meddevlegal
B http://medicaldeviceslegal.com