Update on the MHRA/EMA & Wholesale Dealers Licence Legislation: PDIG Summer Symposium

1. East and South East EnglandSpecialist Pharmacy Services Update on the MHRA/EMA & Wholesale Dealers Licence Legislation:PDIG Summer Symposium 14th June, 2012 National Motor Cycle Museum

2. What has been going on? Informal consultation paper on the review of unlicensed medicines. MLX 365 - Measures to strengthen the medicines’ supply chain and reduce the risk from counterfeit medicines. MLX 375 - Consolidation and review of UK medicines legislation. Falsified Medicines Directive Prevention of sharps injuries in the hospital and healthcare sector (Directive 2010/32/EU)

3. Informal consultation paper on the review of unlicensed medicines (1). Original concept paper launched in February 2008 and the latest version released in May 2009 with a closing date of September 2009. The MHRA has a “problem” in that imports of unlicensed medicines have to be notified and can be challenged by the MHRA, but they have little knowledge or control over unlicensed medicines made in the UK by Specials Licence holders. Proposed a notification scheme whereby manufacturers would inform the MHRA on an annual basis what they intended to make and how much and then check these against a list of “good” and “bad” specials.

4. Informal consultation paper on the review of unlicensed medicines (2). There was also going to be a mechanism to request new products (which would then go onto the good or bad list) and a means of justifying why a blacklisted special really was needed. Wanted basic PILs for specials Still being discussed by the MHRA

5. Informal consultation paper on the review of unlicensed medicines (3). In the meantime a limited list of Specials has appeared in the Drug Tariff. The list was increased in May and is likely to expand over time. The inclusion of unlicensed medicines in the Drug tariff was a response to the perceived practice of wholesale trading of unlicensed medicines to artificially inflate the price. Community pharmacists would invoice the PPA for the cost and then claw back a considerable chunk of the cost for a prompt payment discount. Note that this is not illegal, though one might question the morality!

6. Public consultation (MLX 365): Measures to strengthen the medicines’ supply chain and reduce the risk from counterfeit medicines (1). Followed on from MLX 357 in December 2008 MLX 365 was launched in December 2009 with a closing date of March 2010. Applicants for WDLs must demonstrate they are fit and proper persons and disclose any criminal convictions Application and inspection fees sought in advance and the reduced fee for small traders would be scrapped. The MHRA would maintain a register of all Responsible Persons named on WDLs

7. Public consultation (MLX 365): Measures to strengthen the medicines’ supply chain and reduce the risk from counterfeit medicines (2). RPs would have to undertake approved training and pass an exam every 5 years to stay on the register (this includes existing RPs). The MHRA would not be responsible for running the exams and there would be a fee attached to the commercial training course. Probity of logistic suppliers to be checked by WDL holder Section 10(7) of the Medicines Act 1968 to be scrapped. Section 10 (7) of the Act exempts registered pharmacies from holding a WDL to trade in medicines so long as the value of that trade does not exceed 5% of turnover. The MHRA has a “problem” in that this part of the Act is now contrary to EU law (specifically articles 77(1) & (2) of Directive 2001/83/EC).

8. Public consultation (MLX 365): Measures to strengthen the medicines’ supply chain and reduce the risk from counterfeit medicines (3). This consultation is unlikely to lead to any substantive changes in UK law.

9. MLX 375 – Review & Consolidation of UK Medicines Legislation (1). Followed on from an informal consultation on the Medicines Act 1968 in October 2010. MLX 375 opened on 25th October 2011 and closed on 17 January 2012. The consolidated regulations will primarily implement Directive 2001/83/EC but we will continue to rely on Medicines Act 1968 for powers that fall outside of European obligations. Will replace About 200 statutory instruments and much of the Medicines Act 1968 .Will remove much obsolete law and should result in a shorter simplified law easier to understand and apply. Will reduce net burdens for users, save time and costs and reduce different interpretations of the law.

10. MLX 375 – Review & Consolidation of UK Medicines Legislation (2). Timescale - Spring 2012 consolidated regulations (Human Medicines Regulations) will be laid before Parliament and come into forcein July 2012 The scope - to replace all UK legislation relating primarily to medicinal products for human use (with some exceptions) Outside the scope (or coming later!) medical devices, blood, Good Laboratory Practice, veterinary medicinal products, clinical trials, MHRA fees, Medicines (Administration of Radioactive Substances) Regulations 1978, and Pharmacovigilance.

11. MLX 375 – Review & Consolidation of UK Medicines Legislation (3). What’s not changing? Amendment of section 64 (Protection of purchasers of medicinal products) of the Medicines Act 1968. This leaves the regulator with a “problem” to ensure a proportionate regulatory approach to dispensing errors. - Government does not have the power under EC Act 1972 to change this part of the Medicines Act - Section 64 to remain in force at present - Improvements made by way of guidance - Intention more proportionate regulatory approach to dispensing errors.

12. MLX 375 – Review & Consolidation of UK Medicines Legislation (4). What is changing? 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 (previously set at less than 5% of turnover by value) Not compatible with EU law Pharmacists requiring to trade commercially will require WDL 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 • The MHRA has developed advice for pharmacy on impact of these changes on current practice.

13. MLX 375 – Review & Consolidation of UK Medicines Legislation (5). The MHRA takes the view that the supply of medicines by community and hospital pharmacies to other healthcare providers in the UK who need to hold medicines for treatment of or onward supply to their patients represents an important and appropriate part of the professional practice of both community and hospital pharmacy and falls within the definition of provision of healthcare services. In such circumstances, the MHRA will not deem such transactions as commercial dealing and pharmacies will not be required to hold a Wholesale Dealer’s Licence.

14. MLX 375 – Review & Consolidation of UK Medicines Legislation (6). Pharmacists needing to obtain small quantities of a medicine from another pharmacist to meet a patient’s individual needs may do so without the need for the supplying pharmacy to hold a Wholesale Dealer’s Licence only if the transaction meets all of the following criteria:  • It takes place on an occasional basis and • The quantity of medicines supplied is small and intended to meet the needs of an individual patient and • The supply is made on a not for profit basis.

15. MLX 375 – Review & Consolidation of UK Medicines Legislation (7). What is changing? Removal of ‘statutory warnings’ on labelling, in PILs for certain over the counter medicines. Exception for paracetamol? Sale, supply and administration exemptions: Removal of existing exemption for pharmacists to sell or supply Amyl Nitrate. Extension of existing exemptions for supply of WFI and administration of Adrenaline and other drugs by paramedics. Changes and clarification around Patient Group Directions and what a pharmacist can amend on a prescription without contacting the prescriber (Optimisation of medicines use).

16. MLX 375 – Review & Consolidation of UK Medicines Legislation (8). Amendments to UK’s medicine legislation will continue as will development of EC law Proposal to re-make the consolidated regulations every few years

17. Falsified Medicines Directive 2011/62/EU (1). This was published on 1st July 2011in the OJEU. The new legislation will be applicable from the 2nd January 2013. The new legislation introduces tougher rules to improve the protection of public health with new harmonised, pan-European measures to ensure that medicines are safe and that the trade in medicines is rigorously controlled. Paragraph 2 of the Directive states “There is an alarming increase of medicinal products detected in the Union which are falsified in relation to their identity, history or source. Those products usually contain sub-standard or falsified ingredients, or no ingredients or ingredients, including active substances, in the wrong dosage thus posing an important threat to public health.”

18. Falsified Medicines Directive 2011/62/EU (2). A Falsified Medicinal Product is defined as any medicinal product with a false representation of: (a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients; (b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or (c) its history, including the records and documents relating to the distribution channels used.

19. Falsified Medicines Directive 2011/62/EU (3). Extends the requirements to comply with GMP for the manufacture of active ingredients, whether manufactured within the EU or imported. Introduces obligatory 'safety features' to allow verification of the authenticity of medicinal products for human use ('unique identifier'). EU Concept paper on “unique identifiers” submitted for consultation on 18/11/2011 which closed on 27/4/2012

20. Falsified Medicines Directive 2011/62/EU (4). The concept paper asked; Whether the EU or manufacturers should decide what “unique identifier” was used in the packaging of a medicine? Whether additional information such as BN and Exp should be included? This could be extended to give individual packs in a packaging run a unique serial number with some systems. What sort of “unique identifier” system should be used?

21. Falsified Medicines Directive 2011/62/EU (5). The concept paper also asked; At what point should the medicine be verified; prior to dispensing to the patient, on receipt into the pharmacy or both? Should everyone who handles the medicine in the supply chain verify it as it passes through their hands? Should each manufacturer have their own database of “unique identifiers” or should there be a central EU database for all manufacturers to upload their data onto? What about repackaging? Should these rules only apply to those drugs listed on a “black list”?

22. Prevention of sharps injuries in the hospital and healthcare sector - Directive 2010/32/EU (1). Adopted by the EU on 17/7/2009 and will come into force 10/5/2013. Will be regulated in the UK by the Health and Safety Executive Most of the “Sharps Directive” is already covered by UK health and safety law, so legislative changes will be small. The HSE will consult at some future point on how this is achieved.

23. Prevention of sharps injuries in the hospital and healthcare sector - Directive 2010/32/EU (2). Clause 6: Elimination, prevention and protection 1. Where the results of the risk assessment reveal a risk of injuries with a sharp and/or infection, workers´ exposure must be eliminated by taking the following measures, without prejudice to their order: • Specifying and implementing safe procedures for using and disposing of sharp medical instruments and contaminated waste. These procedures shall be regularly reassessed and shall form an integral part of the measures for the information and training of workers; • Eliminating the unnecessary use of sharps by implementing changes in practice and on the basis of the results of the risk assessment, providing medical devices incorporating safety engineered protection mechanisms; • The practice of recapping shall be banned with immediate effect;