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The Changing Face of EU Legislation
Is the EU moving towards the FDA
model of pharmaceutical
legislation?
By
Robert Smith
Director
Agenda
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Types of EU Legislation
UK Legislation
Current EU Legislation Set Up
What is the Changing Face of EU
Legislation?
Change in Philosophy?
Why the Change in Philosophy?
Legislation Consultation
Other Legislation Affecting Clinical Supplies?
Transitional QPs
Types of EU Legislation
Regulation
 A regulation is a legal act of the European Union
that becomes immediately enforceable as law in all
member states simultaneously. Regulations can be
distinguished from directives which, at least in
principle, need to be transposed into national law
Directive
 A directive is a legal act of the European Union,
which requires member states to achieve a particular
result without dictating the means of achieving that
result. It can be distinguished from regulations which
are self-executing and do not require any
implementing measures
Types of EU Legislation
Delegated Acts
 New category of legal act
 Created in The Treaty of Lisbon
 The legislator delegates the power to adopt acts
amending non essential elements of a legislative act
to the Commission.
 Specify certain technical details
 Subsequent amendment to certain elements of a
legislative act
Types of EU Legislation
Delegated Acts
 Allows the legislator to concentrate on policy
direction and objectives without entering into overly
technical debates
 Delegation of power has strict limits
 Only the Commission can be authorised to adopt
delegated acts
 Furthermore, the legislator sets the conditions under
which this delegation may be implemented.
 Article 290 of the Treaty on the Functioning of the EU
specifies that the Council and the Parliament may
revoke a delegation or limit its duration.
Types of EU Legislation
Guidance and Guideline Documents
 Guidance document are produced to show current
EU thinking non a particular topic
 Guidelines are there to explain how to implement a
directive
 Quasi- judicial documents
 Not legally binding but if you don't follow theme you
nee to demonstrate what you are doing is as good if
not better
 GMP/GCP/ GDP guidances
UK Legislation
Acts of Parliament
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Enabling pieces of legislation that set out the broad brushstrokes of the
legislation
Allow for parliament to add detail with secondary legislation
Primary legislation
E.g. Medicines Act , Health and Safety at Work Act
Regulations / Statutory Instruments
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Secondary legislation that details specific requirements under the
primary legislation
E.g The Human Medicines Regulations are under the Medicines Act
COSSH or Manual Handling Regulations come under the Health and
Safety at Work Act
Most directives are implemented through this route
Current EU Legislation Set Up
• Most of today's pharmaceutical legislation has been
implemented using directives which member states
have implemented into their national law
• In addition there are the various guidelines and
guidance documents published
• Eudralex 4 & 10
What is the Changing Face of EU Legislation?
Change from guidance and guidelines
To legislation
 Regulation
 Directive
 Delegated act
 Similar to system of Code of Federal Regulations in
the US
Change in Philosophy?
Clinical Trial Regulation
• Can't be amended by national regulation
• Expiry date on all labels
Serialisation legislation from FMD directive
• Delegated regulation
• Drawn up by the commission
• Regulation – has to be implemented as approved
Change in Philosophy?
Safety features
 The legislation requires at risk medicines to carry
additional safety features
 Unique code on each medicine pack
 Each pack to have tamper evident device
Have you considered how this will impact on
clinical supplies for rescue medications and
concomitant medication?
Change in Philosophy?
IMP GMP Delegated Act
• New “Annex 13+”
• Not just cover specific GMP requirements of IMP
• Also cover general GMP requirements
• Likely to be either a directive or a regulation as
compared to a guideline or guidance document
• MHRA is the lead rapporteur
Why the Change in Philosophy?
Purely speculative on my part
 Want to avoid the mess of the CT directive
implementation
 Want to hold drug companies and QPs to account
 Potentially have specialist inspectors across EU
 Small molecule
 IMP
 ATMPs
 Biologicals
 Align with US as part of trade negotiations
Legislation Consultation
Any new EU legislation that’s proposed goes
out to public consultation
Various means you can use to be alerted of
new changes to EU pharma legislation
You have an opportunity to change opinions
 Greater Degree
 Lesser degree
Process for suggesting changes is usually
quite straightforward
Other Legislation Affecting Clinical
Supplies?
GDP Guidelines
 Comparator Product
 Rescue Medication
 Concomitant Meds
 Commercial Product
 Subject to the GDP guidelines
 Do you have the appropriate authorisations in
place?
Transitional QPs
CT Regulation has no provision for Transitional
QPs
 Understood this to mean that needed to become a
QP by the permanent route
 Did not affect current transitional QPs
 MHRA GCP Symposium, MHRA in answer to a
question
 No provision for Transitional QPs
Transitional QPs
 Major implications for UK Industry but not rest
of EU
 250 – 300 Transitional QPs affected
 Joint Professional Bodies who administer
QPs for MHRA are probably unable to cope
with assessing QPs from Transitional to
Permanent
 Potential legal implications
Transitional QPs
The MHRA response:
“We are aware that there is no provision for transitional QPs
in the new Clinical Trials Regulation; we have queried this
with the Commission and they have confirmed that this is the
case. This appears to be largely a UK issue as most other
member states did not use the transitional option when it was
available to them. The MHRA is working together with our
legal team, and we are looking for options which will cause
the least disruption when the CT Regulation is applied. As
implementation of the Regulation is now unlikely until late in
2017, we will continue to explore solutions and will
communicate with stakeholders in due course”
Questions?