Regulatory Changes currently under consultation

1. Regulatory Changes currently under consultation Richard Bateman Quality Assurance Specialist Pharmacist

2. Scope Consolidation and review of UK medicines legislation (MLX 375) Falsified Medicines Directive (2011/62EU) MHRA Review of Unlicensed Medicines NHSPQAC “Guidance on the licensing requirements of prepacking and overlabelling operations”

3. MLX 375 Timescales Legal Powers The consolidation – key points Government and NHS Reform Consolidation Patient Group Directions Optimisation of medicines Keeping up to date Summary

4. Timescales • Consolidation and review of UK medicines legislation Public consultation MLX 375 responses by 17 January 2012 • Spring 2012 consolidated regulations (Human Medicines Regulations) before Parliament • July 2012 come into force • Expected shortly related consultation (MLX 374) on pharmacovigilance requirements European Directive 2010/84/EU • Directive implemented July 2012 • European Directive 2011/62/EU on falsified medicines implementation by 2 January 2013

5. Legal Powers • ‘Consolidated regulations will primarily implement Directive 2001/83/EC • Continue to rely on Medicines Act 1968 for powers that fall outside of European obligations

6. The consolidation – key points from MLX 375 Will replace • About 200 statutory instruments • Much of the Medicines Act 1968 Will remove • Much obsolete law Will result in • Shorter simplified law easier to understand and apply Will reduce • Net burdens for users • Save time and costs • Different interpretations of the law

8. Government & NHS Reform • A ‘priority to minimise regulatory burdens in order to boost enterprise and drive growth’ – ‘One in, One out’ • ‘The consolidation is not part of proposed NHS reforms, but we will aim to ensure that the consolidated regulations reflect any changes to the NHS legislation as necessary’ • To include changes to Patient Group Directions

9. Consolidation • To replace all UK legislation relating primarily to medicinal products for human use (with some exceptions)

10. Scope of the consolidation (1) IN – Pharmacy includes: • Medicines Act 1968 • Part III Medicines Act 1968 - dealing in medicinal products, classification) • Large parts repealed • (But Act stays) • Prescription Only Medicines (human Use) Order 1997 (SI 1997/1830) – (with exceptions Sch. 1 POMs status for medicines supplied without a MA) • Enforcement functions of the GPhC (sections 108 and 109 Medicines Act 1968 (with exceptions) • Pharmacy qualifications for QPs in relation to a manufacturers' licence

11. Scope of the consolidation (2) OUT (or coming later!) • Section 10 is not consolidated and will be retained in the Medicines Act 1968 amended to refer to the consolidated regulations • Exception – subsection (7) to be repealed • Areas of MHRA regulation no covered – medical devices, blood, GLP, veterinary medicinal products • MHRA fees • Medicines (Administration of Radioactive Substances) Regulations 1978 • Certain Prohibition orders (e.g. Chloroform, Kava-kava)

12. Scope of the consolidation (3) • Clinical trials • Ongoing negotiations in Europe • Directive requiring substantial changes to the regulation of clinical trials • Chancellor to review UK implementation of the CTD to ‘reduce perceived gold plating and to increase proportionality of the system’

13. Scope of the consolidation (4) • Removal of the Section 10(7) Medicines Act 1968 exemption for pharmacy wholesale dealing • Exemption permits pharmacists to trade in small quantities of medicines without WDL • Not compatible with EU law • Pharmacists requiring to trade commercially will require WDL • WDL not required if medicines provided to healthcare professionals and others to pass on to their patients • Pharmacists allowed to supply other pharmacists with small quantities without WDL on occasional and not for profit basis and to meet individual needs of patients • Considering placing certain new obligations on wholesale dealers and RPs . ‘If we were to decide’ included in consolidated regulations 2012 • MHRA developing advice for pharmacy on impact of these changes on current practice (see impact assessment) with ‘duty to review clause’.

14. Scope of the consolidation (5) • Amendment of section 64 (Protection of purchasers of medicinal products) of the Medicines Act 1968 to ensure a proportionate regulatory approach to dispensing errors • MHRA do not have the powers under EC Act 1972 • Section 64 to remain in force at present • Improvements made by way of guidance • Intention more proportionate regulatory approach • Way forward to be discussed with interested parties Autumn 2011

15. Also included in consolidating the law (1) • Sections 9 to 12 (NOT section 10) removed • ‘we think that practitioners will be able to continue to conduct professional activities …) • Therapeutic rather than commercial context and not industrially produced • ‘MHRA will issue guidance (Note term ‘prepared’ replaced with ‘manufactured’)

16. Also included in consolidating the law (2) • Offence provisions • Civil sanctions to address breaches of advertising and borderline requirements • Due diligence defence • Sch.1 Medicines for Human Use (MAs, etc) Regulations 1994 (SI 1994/3144) • Permits supply of unlicensed medicines to a person for administration during the course of their business to a patient under their care • Clarified (defines authorised healthcare professionals)! • Removal of the requirement for fluted bottles

17. Also included in consolidating the law (3) • Policy changes (6 sections in MLX) • ‘Legislation currently requires MA holders to include ‘statutory warnings’ on labelling, in PILs for certain over the counter medicines’ • Propose to remove them and replace with product-specific or class warnings in MA • Exception for paracetamol?

18. Also included in consolidating the law (4) • Extension of existing exemptions • Sale of supply of medicines to organisations concerned with research - extend to other organisations • Increasing the 2ml ampoule size limit for water for injection – used by drug treatment services • Removal of restriction on parenteral administration of adrenaline (1 in 1000) • Additions to medicines that can be administered by registered ambulance paramedics on their on initiative – addition IV Paracetamol, Ondansetron

19. Also included in consolidating the law (6) • New exemptions • Water for injection • Currently classified as a POM • Obtain without a prescription for other purposes not parenteral administration • Administration of Adrenaline and Amiodarone • By holders of Resuscitation Council (UK) Advanced Life Support certificate in cardiac arrest

20. Patient Group Directions (1) • Duplication of effort • Raise awareness of the PGD website hosted by NeLM • Retain general structure and requirements in their current form • Will make minor changes • Enabling an NHS body to supply in accordance with written directions by an independence nurse, pharmacist or optometrist independence prescriber • Reflecting changes in the Care Quality Commission registration process • New provision • Allowing dental practices dental clinics registered with the CQC to sell, supply or administer medicines under PGDs

21. Optimisation of medicines use • ‘In the exercise of professional skill and judgement they believe it is appropriate to do so a pharmacist may make changes to a prescription relating to a) name of the product or common name; b) directions for use ; precautions relating to the use of the product.’ • Only if the pharmacist cannot contact the prescriber • Commonly interpreted as optimising the use of the medicine eg dose, duration • Proposal to remove above (not to interfere with clinical reason for prescribing)

22. Keeping the consolidated regulations up to date • Amendments to UK’s medicine legislation will continue as will development of EC law • Proposal to re-make the consolidated regulations every few years • MHRA to undertake a ‘Regulatory Excellence’ programme • To focus on lifting the burdens on business • Feedback to the ‘Red tape Challenge’ • Informal consolidated version of regulations each time amended on website (not legal)

23. Falsified Medicines Directive 2011/62 EU • Needs to be enacted by 2/1/13 • No consultation yet. • Pre consultation questionnaire. Closing date 3/2/12. V short turnaround – may still make comments. • Looking at potential economice impact assessment

24. Falsified Medicines Directive 2011/62 EU • Amends 2001/83EC • Brokering activities – formal controls • WDL – need for supply to 3rd country • Import notification for centrally authorised products • WD to verify products received are not falsified

25. Falsified Medicines Directive 2011/62 EU • Safety features – to be defined • Not all to require – POM? • Tamper evident seal and unique pack identifier – bar codes, RFID? • APIs – additional controls – audit, GMP, GDP, registration • If safety features are removed ? Need to replace with equivalent?

26. Review of Unlicensed Medicines • Started 2007 – concept paper, interim report, consultation • Late 2010 – March 2011 – “update in light of coalitions regulatory agenda” • March 2011 onwards ????????

27. RUM – what was not changed from consultation • Quality and manufacturing standards applying to Specials • Strengthen pharmacovigilance • Advertising

28. RUM – changes proposed after consultation • Patient Information – healthcare professionals judgement • Notification system for both domestic manufacture and imports • Notification – safety concerns / need • Labelling – English (NB NHSPQAC guidance) • Regulatory Impact?

29. NHSPQAC Guidance • “Guidance on the licensing requirements of prepacking and overlabelling operations” • To be published shortly • Clarification of existing position regarding these activities within the NHS Trusts • Should be referred to when reviewing an assembly activity to decide whether the activity requires an MHRA license or can be carried out under S10