REGULATORY AND LEGAL ASPECTS OF 3D PRINTING AND BIOFABRICATION

Utrecht Summer School Course 14 July 2015

Sofie van der Meulenwww.axonlawyers.com

Yesterday…

Superstars… & superheroes

Agenda

• How does the law see 3D printing?• Intellectual property• Personal data

Is it all that revolutionary?

Dental has been doing this for ages

How the law sees 3D printing + biofabrication

You use a production facility

• Medical devices and medicinal products production facilities are regulated (GMP, ISO 13485)

You make a product that can be regulated

• Medical device (or accessory), advanced therapy medicinal product or something else

You procure and use materials that can be regulated

• Parts for devices and substances for medicinal products are regulated; harvest, transport and use of biologic (tissues, cells) material is regulated

How the law sees 3D printing

You apply a production process that can be regulated

• Manufacturing processes for medicinal products and medical devices require a quality system

• NCAs / notified bodies may perceive design/production tools as medical devices (e.g. design software)

You use data that pertain to an identified or identifiable person

• Collection and processing of personal data concerning health

• Customization links objects to persons

• Data can be breached, stolen etc

Regulation of the printer

Currently: EU Machinery Directive

Regulation of the material

• REACH (chemical substances)

• EU Tissues & Cells Directive (live cells and tissues)

Regulation of the material• Intermediate material to be printed may constitute

medical device under current Commission guidance for custom made devices

• Special regime for medical devices manufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissue (e.g. proteins)

Regulation of the end result

• Can be a medical device

Regulation of the end result

OR

• Can be an accessory to a medical device

• e.g. surgical guides

Regulation of the end result• Can be an advanced therapy medicinal product• OR a combination ATMP

Regulation of the end result

• Printing ‘old style’ medicinal products

Regulation of the end result

• Can be none of the foregoing, e.g.

• pre-op models• tissue models for research,

drug discovery and toxicology.

Regulation of the end result

Medical devices law

• Currently default regulatory position: custom-made device

• Prescription defines end result but production technique is standardized

• Question: what is “custom” about a 3D printed medical device?

Regulation of the end result

ATMP regulation

• Tissue engineered product

• May contain additional substances or objects, like scaffolds

• ATMP unless completely unviable• Cells / tissues substantially manipulated• Combined advanced therapy medicinal products

Regulation of the end result

New Proposal on Medical Device Regulation

• increases standards for non custom-made 3D printed medical devices by introducing stricter identification (UDI), traceability and registration requirements

• Parliament proposal to exclude mass produced customized devices from scope of custom made devices

• No provision in new Regulation for

• 3D printing• biofabrication

Regulation of the activity

• Quality system requirements / GMP requirements

Regulation of the activityGMP requirements

• can turn out very cumbersome and unpractical for bedside applications – ATMP GMP requirements are geared towards development this at all (assumed to take place in industrial process in a fixed “facility”)

• NCAs generally risk averse and exhibit ‘department of no’ mentality and diverge in their assessments

• innovative companies get stuck in compromise solutions like hospital exemption under ATMP regulation

• no basis for viable business model• no basis for applied technological innovation

Regulation of the activity

ATMP regulation currently subject to revision; some careful optimism warranted based on Commission findings regarding

• autologous ATMPs• combined ATMPs

Yes, please!

Regulation of the activity

Some notified bodies have started to request CE marking as standalone software medical device of

• final product design software• customer requirements fine-tuning collaboration

software

IMHO unlawful approach – regulation of production tools as medical devices that will be placed on the market

IP: Copyright - softwareProtects the original form or expression of information but not the underlying information itself. -> specific algorithm

• “original” only if “selection or arrangement of contents is author’s own intellectual creation”.

• Infringement by translation or making an altered version. Successful claim needs to show at least:

• That copyright exists (pragmatic approach ‘what is worth copying is worth protection’)

• Claimant owns the copyright• Work is within copyright (life plus 70 years for software

and databases)• Infringement (substantial part is reproduced without

authorisation)

IP: Patents

Patents

• Printing method (e.g. living cells)• End result (ear with particular properties)• Printing materials

Intellectual property: body parts

Personal data3d printing related activities involve collection and processing of personal data concerning health and biometric data on many levels

• Data from hospital’s electronic health records• Generation of patient related data for end product• Data in files describing the final product• etc.

Who controls the data?

• Controller has regulatory burden, must conclude processing agreement with others that get access to the data

Where is the data?

• External printing lab?• Hosted? • Sent outside of EU for e.g. modeling / printing?

Personal dataCurrently existing EU guidance relevant for 3D printing:

• personal data as concept

• WP 136 on concept of personal data• WP 192 on facial recognition

• personal data concerning health

• WP 131 on the processing of personal data relating to health in electronic health records (EHR)

• WP 189 on eHealth and privacy• Letter of WP29 of 5 February 2015 on health data

• biometric data

• WP 80 working document on biometrics• WP 193 on biometric data

New data protection regulation will be regulatory nightmare for 3DDifferent definitions for biometric data and data concerning health

In 3D printing definitely overlaps between these, but different requirements in regulation (biometric data not subject to health data processing exemptions in article 81 and 83) – problematic because also a ‘special category’ (prohibited unless)

should have said: “is collected for the purpose of”

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THANKS FOR YOUR ATTENTION!

Sofie van der MeulenAxon LawyersPiet Heinkade 1831019 HC AmsterdamT +31 88 650 6500F +31 88 650 6555M +31 6 53 44 05 67E sofie.vandermeulen@axonlawyers.com

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