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PHARMACY PRACTICES COMMITTEES

PHARMACY PRACTICES COMMITTEES. SEMINAR 6 APRIL 2001. ENTRY TO THE PHARMACEUTICAL LIST. CONTROL OF ENTRY TO THE PHARMACEUTICAL LIST. THE LEGISLATIVE FRAMEWORK. THE NATIONAL HEALTH SERVICE (PHARMACEUTICAL SERVICES) (SCOTLAND) REGULATIONS 1995. OPERATIVE 31 MARCH 1995.

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PHARMACY PRACTICES COMMITTEES

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  1. PHARMACY PRACTICES COMMITTEES SEMINAR 6 APRIL 2001

  2. ENTRY TO THE PHARMACEUTICAL LIST

  3. CONTROL OF ENTRY TO THE PHARMACEUTICAL LIST THE LEGISLATIVE FRAMEWORK

  4. THE NATIONAL HEALTH SERVICE (PHARMACEUTICAL SERVICES) (SCOTLAND) REGULATIONS 1995 OPERATIVE 31 MARCH 1995

  5. INTRODUCTION OF CONTROL OF ENTRY • NATIONAL HEALTH SERVICE (AMENDMENT) ACT 1986 CH. 66 • NATIONAL HEALTH SERVICE (GENERAL MEDICAL AND PHARMACEUTICAL SERVICES) (SCOTLAND) AMENDMENT REGULATIONS 1987 (SI 1987 No. 385 (s. 35) • NHS CIRCULAR : GEN (1987) 14

  6. STATUTORY INSTRUMENTS 1995 REGULATIONS AND SUBSEQUENT • NHS (PS) (S) Regs 1995 (SI 1995 No. 414) • NHS (PS) (S) Amend. Regs 1996 (SI 1996 No. 840) • NHS (PS) (S) Amend. Regs 1996 (SI 1996 No. 1054) • NHS (PS) (S) Amend. Regs 1997 (SI 1997 No. 696)

  7. STATUTORY INSTRUMENTS 1995 REGULATIONS AND SUBSEQUENT (CONTINUED) • NHS (PSPDS:MPCA) (S) Regs 1998 (SI 1998 No. 2224) • NHS (PS) (S) Amend. Regs 1998 (SI 1998 No. 3031) • NHS (PS) (S) Amend. Regs 1999 (SSI 1999 No. 57) • NHS (PS) (S) Amend. Regs 2001 (SSI 2001 No. 70)

  8. CIRCULARS ISSUED SUBSEQUENT TO INTRODUCTION OF CONTROL OF ENTRY • NHS 1987 (GEN) 14 • NHS 1988 (GEN) 22 • NHS 1989 (GEN) 37 • NHS 1989 (PCS) 26 • NHS GEN (1992) 17 • NHS GEN (1992) 26 • NHS PCS (P) (1993) 1

  9. CIRCULARS ISSUED SUBSEQUENT TO INTRODUCTION OF CONTROL OF ENTRY (CONTINUED) • NHS PCS (P) (1993) 2 • NHS PCA (P) (1993) 1 • NHS MEL (1997) 21 • NHS PCS (P) (1998) 1

  10. THE 1995 REGULATIONSSTRUCTURE AND CONTENT • REGULATIONS 1 - 13 • SCHEDULES • 1 - TERMS OF SERVICE FOR PHARMACISTS • 2 - FORMS • 3 - PROCEDURE ON APPLICATIONS UNDER REGULATION 5 (10) • 4 - PART 1 - PHARMACY PRACTICES COMMITTEE PART 2 - NATIONAL APPEAL PANEL • 5 - REVOCATIONS

  11. APPLICATION FOR ENTRY TO THE PHARMACEUTICAL LISTREGULATION 5 - PHARMACEUTICAL LIST • 5(1) - THE PHARMACEUTICAL LIST • 5 (2) - FORM A / FORM A (MR) • 5(10) - “THE PROVISION OF PHARMACEUTICAL SERVICES AT THE PREMISES NAMED ON THE APPLICATION IS NECESSARY OR DESIRABLE IN ORDER TO SECURE ADEQUATE PROVISION OF PHARMACEUTICAL SERVICES IN THE NEIGHBOURHOOD IN WHICH THE PREMISES ARE LOCATED..” • 6 - PROVISIONAL PHARMACEUTICAL LIST

  12. MINOR RELOCATIONS • REGULATION 5(4) (a) - “... RELOCATE .. WITHIN THE NEIGHBOURHOOD ... FROM THE PREMISES ALREADY LISTED .. TO.. PROVIDE...THE SAME PHARMACEUTICAL SERVICES ... AS ..FROM .. EXISTING PREMISES.” • (b) THE APPLICATION SHALL BE GRANTED • IF “..SATISFIED THAT RELOCATION IS A MINOR RELOCATION..” • (c) - NON INTERRUPTION CONDITION - PARA (5)

  13. MINOR RELOCATIONS • REGULATION 5(6) -“..NO SIGNIFICANT CHANGE IN THE NEIGHBOURHOOD POPULATION..” AND “..NO APPRECIABLE EFFECT ON THE PHARMACEUTICAL SERVICES PROVIDED BY .. APPLICANT OR ANY OTHER PERSON.. INCLUDED IN THE PHARMACEUTICAL LIST…” • REGULATION 5(7) - VIEWS OF THE AREA PHARMACEUTICAL COMMITTEE AND MOST SENIOR PHARMACEUTICAL ADVISER • REGULATION 5(8) - WRITTEN NOTIFICATION WITH REASONS

  14. MINOR RELOCATIONS - CASE STUDY • DECISION OF THE INNER HOUSE OF THE COURT OF SESSION • BOOTS THE CHEMIST Ltd -v-AYRSHIRE AND ARRAN PRIMARY CARE NHS TRUST • 15 DECEMBER 2000

  15. CONTROL OF ENTRY - PROCEDURES IN TERMS OF THE REGULATIONS • REGULATION 5(10) - REFERENCE TO PROCEDURES IN SCHEDULE 3 • SCHEDULE 3 :- • 1 - RECEIPT AND NOTIFICATION OF APPLICATIONS • 2 - DETERMINATION OF APPLICATIONS • 3 - NOTIFICATIONOF DECISIONS • 4 - APPEALS

  16. THE PHARMACY PRACTICES COMMITTEE • SCHEDULE 3 • PARA 2(6) • FUNCTIONS OF THE BOARD OR PRIMARY CARE NHS TRUST..SHALL BE EXERCISED BY THE PHARMACY PRACTICES COMMITTEE

  17. THE PHARMACY PRACTICES COMMITTEE • SCHEDULE 4 • 1 - ESTABLISHMENT • 2 - FUNCTIONS - REGULATION 5(10) AND SCHEDULE 3 PARA 2 • 3 - MEMBERSHIP • 4 - DECLARATION OF INTEREST • 5 - QUORUM • 6 - VOTING

  18. DETERMINING THE APPLICATION • SCHEDULE 3 - PARA 2 (2) • DETERMINE AN APPLICATION AS PPC THINKS FIT • IN ACCORDANCE WITH THE SCHEDULE • SCHEDULE 3 - PARA 2 (1) • INFORMATION/REPRESENTATIONS TO WHICH THE PPC SHALL HAVE REGARD IN DETERMINING THE APPLICATION

  19. PRACTICAL CONSIDERATIONS • STRICT ADHERENCE TO THE REGULATIONS • PREPARATION OF INFORMATION FILE • CONSIDERATION OF SITE VISIT • THE TYPE OF MEETING - ORAL REPRESENTATIONS • FIXING THE MEETING - NOTICE • CONDUCTING THE HEARING - USE OF THE GUIDANCE NOTES

  20. THE LEGAL TEST • REGULATION 5(10) • APPLICATION SHALL BE GRANTED • IF NECESSARY OR DESIRABLE • TO SECURE ADEQUATE SERVICE • IN THE NEIGHBOURHOOD IN WHICH THE PREMISES ARE LOCATED • CONSIDER IN REVERSE ORDER

  21. NEIGHBOURHOOD • NO DEFINITION • JUDICIAL GUIDANCE - PETITION OF BOOTS THE CHEMIST LTD 1999 and • ALLIANCE AND ECONOMIC INVESTMENT CO v BERTON 1932 • ORDINARY MEANING • IT IS A PLACE • VICINITY OR NEARNESS • CONSIDER EXAMPLES (Refer to example neighbourhoods)

  22. ADEQUACY OF EXISTING SERVICES • EXISTING SERVICES IN THE NEIGHBOURHOOD • BY PROVIDERS IN AND OUTWITH THE NEIGHBOURHOOD • LOOK AT PATIENT NEEDS • LOOK AT DEMOGRAPHIC INFORMATION • CONSIDER THE RANGE OF EXISTING SERVICES AND THE HOURS • VIABILITY ISSUES • RELOCATIONS

  23. NECESSARY OR DESIRABLE • EMPHASIS ON "OR" • NECESSARY - NO REAL NEED TO CONSIDER DESIRABLE • NOT NECESSARY - MAY BE DESIRABLE • R v YORKSHIRE RHA ex parte BAKER - JUDICIAL REVIEW • WHOLLY INADEQUATE - NECESSARY • ALREADY ADEQUATE - NEITHER • BORDERLINE - DESIRABLE

  24. GENERAL POINTS • CONSIDER FUTURE CHANGES • AVOIDING THE CONVENIENCE FACTOR • CONFUSING CONVENIENCE WITH DESIRABLE (OR PERHAPS ADEQUACY) • EACH CASE TO BE TREATED ON ITS OWN MERITS

  25. FORMULATION AND CHALLENGE PHARMACY PRACTICES COMMITTEE DECISIONS

  26. DRAFTING THE DECISION • THE KEY ROLE OF THE ADMINISTRATOR • THE VALUE OF MINUTES • USING “THE CHECKLIST” • LIAISON - CHAIRPERSON / ADMINISTRATOR • NOTIFYING PARTIES OF THE COMMITTEE DECISION

  27. IMPORTANCE OF THE WRITTEN DECISION WITH REASONS • SCHEDULE 3, PARAGRAPH 3 (1995 REG'S) • REASONS FOR EACH OF THE KEY ELEMENTS • CLEAR • BASED ON EVIDENCE • RATIONAL • ADVANTAGES FOR YOU OF GIVING REASONS • STYLE OF DECISION

  28. CHALLENGING THE PPC's DECISION • WHO CAN CHALLENGE? • PARA 4 TO SCHEDULE 3 OF THE 1995 REGULATIONS • GROUNDS FOR CHALLENGE • EXAMPLES • DISCLOSE NO REASONABLE GROUNDS OR OTHERWISE VEXATIOUS OR FRIVOLOUS • CHAIRMAN'S DECISION FINAL

  29. THE NATIONAL APPEAL PANEL • CONSTITUTION OF PANEL • QUORUM OF PANEL • VOTING ON PANEL • INFORMATION REQUIRED BY PANEL • MAPS • NOTIFYING THE PARTIES OF PANEL'S DECISION

  30. CHALLENGING THE NATIONAL APPEAL PANEL'S DECISION • JUDICIAL REVIEW • WHO CAN BRING PROCEEDINGS • NO STRICT TIME LIMITS

  31. CHALLENGING THE NATIONAL APPEAL PANEL'S DECISION • WORDIE PROPERTY v SECRETARY OF STATE FOR SCOTLAND 1984 SLT 345 A decision of the S of S … will be ultra vires if it is based upon a material error of law going to the root of the question for determination. It will be ultra vires, too, if the S of S has taken into account irrelevant considerations or has failed to take account of relevant and material considerations which ought to have been be taken into account. Similarly it will fall to be quashed on the ground that, if where it is one for which a factual basis is required, there is no proper basis in fact to support it. It will also fall to be quashed if it…is so unreasonable that no reasonable S of S could have reached…it.

  32. CHALLENGING THE NATIONAL APPEAL PANEL'S DECISION • GROUNDS FOR JUDICIAL REVIEW • NO REASONS • FAILURE TO TAKE INTO ACCOUNT • TAKING INTO ACCOUNT IRRELEVANT CONSIDERATIONS • NO FACTUAL BASIS FOR DECISION • NO REASONABLE PERSON COULD HAVE REACHED THAT DECISION • POWERS OF THE COURT

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