The Changing Face of EU Legislation

1. The Changing Face of EU Legislation Is the EU moving towards the FDA model of pharmaceutical legislation? By Robert Smith Director

2. Agenda 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

3. 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

4. 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

5. 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.

6. 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

7. UK Legislation Acts of Parliament • 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 • 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

8. 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

9. 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

10. 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

11. 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?

12. 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

13. 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

14. 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

15. 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?

16. 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

17. 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

18. 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”

19. Questions?