TRANSPARENCY AND CONFIDENTIALITY IN MEDICAL DEVICES REGULATIONS

Innovation at the interface30-31 October 2014

Erik Vollebregtwww.axonlawyers.com

Overview

• Current transparency and confidentiality rules under MDD• Transparency and confidentiality under MDR and IVDR proposals• Developments in pharma transparency and comparison with EMA policy• National freedom of information rules

Transparency and Confidentiality under the MDD

Annex X, Clinical Evaluation

• Information exchange only between the competent authorities of the Member States and the Commission

• Such information is not accessible to the public (patients, healthcare professionals etc.)

Transparency and Confidentiality under the MDD

However:

And:

Transparency and Confidentiality under MDR

1st Reading of Parliament (2 April 2014)

Recital 39a

Wha

t is “c

orre

spon

ding”

?

“hig

h-ris

k de

vice

” – o

nly

clas

s

III?

Not

“low

risk

”?

Par

liam

ent p

ropo

ses

that

they

are

, act

ually

“All”

data?

Not re use by others?

Transparency and Confidentiality under MDR

1st Reading of Parliament (2 April 2014)

Transparency purposes of Eudamed (Article 27):

• to adequately inform the public about devices, certificates , ...with due regard to commercial

confidentiality where justified:

• to adequately inform the public and health professionals about clinical investigations and

market surveillance activities:

Transparency and Confidentiality under MDR

1st Reading of Parliament (2 April 2014)

Electronic system on clinical investigations (Article 53):

• Only the information under(d) and (da) shall be accessible to the public

• The information under (b) and (c) shall be accessible only to the Commission and the

Member States

• Healthcare professionals shall have access too

Transparency and Confidentiality under MDR1st Reading of Parliament (2 April 2014)

• Adverse events and safety data are not commercially sensitive info

Transparency and Confidentiality under MDR

1st Reading of Parliament (2 April 2014)

Electronic system on vigilance (Article 62):

Transparency and Confidentiality under MDR

1st Reading of Parliament (2 April 2014)

The data entered in the electronic system on vigilance shall be accessible to (Article 62(2)):

• the competent authorities of the Member States

• the Commission

• notified bodies

• healthcare professionals

• manufacturers, where the information pertains to their own product

• public shall have access to the system at an appropriate level

Transparency and Confidentiality under MDR

1st Reading of Parliament (2 April 2014)

Issues with the access of the public to the information in clinical investigations and vigilance electronic systems:

• Public access to the electronic system on clinical investigations, Article 53(2) & 53(2a):

• healthcare professionals shall have access to the system too, but its not if they will

have access to all the information, and if not to which part of it.

• Remember recital 39a: access limitations only for other manufacturers?

• Does it mean that public may have access to all the information, even if it exceeds what

letters (d) and (da) of Article 53(1) allow?

Transparency and Confidentiality under MDR

1st Reading of Parliament (2 April 2014)

• Public access to the electronic system on vigilance (Article 62(3)):

- the term “appropriate level” is undefined.

- the level of access by public to this system is not restricted by the “commercially

sensitive information” criteria.

The level of access by public to this system’s data is too vague.

Transparency and Confidentiality under IVDR

Recitals 30 & 32a:

Transparency and Confidentiality under IVDR

• Article 24(1) and 24(1a) – Summary and clinical performance report:

The manufacturer of medical devices classified as class C & D (other than devices for

performance evaluation) shall draw up:

i) report on the safety and clinical performance of the device;

ii) a summary of the report, in a language easy to understand by the law person in

the country where the device is made available;

Only the summary shall be made available to the public via the Eudamed.

Transparency and Confidentiality under IVDR

• Article 51:

• Information under (b) and (c) shall be accessible only to the Commission and the MS.

• Information under (d) and (da) shall be accessible to the public in accordance with the

protection of personal data and commercially confidential information.

• Healthcare professionals shall have access too.

Transparency and Confidentiality under IVDR

• Article 60 – Electronic system on vigilance:

Transparency and Confidentiality under IVDR

The information entered in the electronic system on vigilance shall be accessible to:

• the competent authorities of the Member States

• the Commission

• the notified bodies

• healthcare professionals

• manufacturers, where the information pertains to their own product

• public shall have an `appropriate level` of access (the term is undefined)

Transparency and Confidentiality under IVDR

• Article 66 – Electronic system on market surveillance:

• competent authorities of the Member States, the Commission, the Agency (EMA) and the

healthcare professionals.

• public shall have access at an `appropriate level`.

Developments in Pharma Transparency

• Both AbbVie and InterMune dropped their cases in the appeal phase before the ECJ;

• EMA adopted Policy/0070 on publication of clinical data for medicinal products for human use on 02/11/2014

• provides definition of CCI

• “CCI is defined, for the purpose of the policy, as 'any information contained in the

clinical reports submitted to the Agency by the applicant/marketing authorisation

holder (MAH) that is not in the public domain or publicly available and where

disclosure may undermine the legitimate economic interest of the applicant/MAH’.”

• contains a closed list of the sort of information that may be considered as ‘commercially confidential’

• possibility to redact submitted information

Comparison (high level)

• MDR and IVDR apply undefined term ‘commercially sensitive data’, while EMA policy does define this and has Annex I with CCI examples

• MDR and IVDR do not contemplate possibility to redact, while EMA does

• MDR and IVDR contemplate delegated acts (article 53 (3) MDR) while EMA will use sets of ToU depending on

• access the data for general information purposes or • academic and non-commercial research purposes

• EMA policy will apply only to clinical information under EMA competence, MDR and IVDR will apply to all MDD and IVDD information in the whole EEA

Comparison

Link to Annex D of EN 14155:2011 (Medical devices GCP) – Clinical Investigation Report

May

be

reda

cted

D.1 General

Comparison

D.6.2 Clinical investigation plan (CIP)

sub i) (statistical analysis)

D.7 Results sub f):Performance analysis

D.6.2 Clinical investigation plan (CIP) sub e) (subject population incl.

sample size)

Freedom of information nationally

• Notified body covered as emanation of state?• NCA covered insofar as they have access to documents notified body?• Freedom of Information request may be routed via manufacturer for

redaction

www.axonlawyers.com

THANKS FOR YOUR ATTENTION

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

READ MY BLOG:http://medicaldeviceslegal.com