APPENDIX 2
Supplementary memorandum by the British
Generic Manufacturers Association (GD4A)
There were two or three issues which came up
in last Thursday's hearing where we may be able to help the Committee
further. My colleague, Joanne Bullen, has alerted you to the fact
that we should be submitting this further evidence.
1. RELATIVE COSTS
OF GENERICS
The Committee made clear that it would welcome
information on the cost of the same products in different countries.
At Annex A is a list, prepared by one of the Association's member
companies, of prices of a range of products in the UK, Germany
and The Netherlands.
2. PHASING OF
THE INTRODUCTION
OF PATIENT
PACKS
There was considerable debate about whether
the current or the previous government had agreed to phasing the
introduction of patient packs, by therapeutic category. I enclose
at Annex B:
— A letter dated 18 March 1997 from
the then Minister for Health, Gerry Malone MP, to me confirming
"the Government's unequivocal support for an incremental
move to supply medicines in patient packs".
— A table showing the proposed phased
introduction.
— A copy of the brochure prepared to
explain the moves to patient packs[1].
Following the change of government, incoming
ministers questioned what they characterised as the "cost
and complexity" of the proposed move to patient packs. There
were protracted discussions between the Department on the one
hand, and the industry and the professions on the other, during
which we argued that the proposed change was the most cost-effective
way of meeting the requirements of the EC labels and leaflets
directive.
This debate continued until the publication
by the Medicines Control Agency of its formal consultation letter
of 11 September 1998. MLX 247, on the implementation of the Directive.
We responded on 23 October 1998. To date, we have had no response
from the MCA or the Department of Health. Manufacturers have,
therefore, reached their own conclusions on how best to comply
with the provisions of the Directive, and have chosen to do so
by introducing patient packs.
Because there is no agreed timetable or mechanism
for this, a shift to patient packs by one manufacturer without
provision for the reimbursement price to be included within the
Drug Tariff, means that bulk supplies may be in short supply and
move to Category D, with the implications that were discussed
at the hearing, even though there are ample aggregate supplies
of the medicine itself.
3. ADDITIONAL
BACKGROUND INFORMATION
I am enclosing at Annex C a copy of the Association's
Chairman's speech at our annual dinner in the Spring, from which
he read during his evidence to the Committee on Thursday. [2]
I also take this opportunity to repeat the invitation
which my Chairman extended to the Committee in oral evidence to
visit one of our members' manufacturing facilities. We should
be very happy to arrange this, either as part of this Inquiry,
or distinct from it to help further the Committee's understanding
of the generic industry.
9 November 1999
Annex A
PRICE COMPARISON OF GENERIC MEDICINES IN
THE NETHERLANDS, GERMANY AND THE UK 1998
| US$
| US$
| US$
| |
|
| Netherlands
|
Germany
| UK
| | Pack Size
|
Atenolol Tabs 25mg
| 2.67
| 4.25
| 0.43
|
ATEBETA
| 30
|
Atenolol Tabs 50mg
| 3.19
| 7.51
| 0.42
|
ATEBETA
| 30
|
Atenolol Tabs 100mg
| 5.08
| 12.13
| 0.53
|
ATEBETA
| 30
|
Amoxycillin Caps 500mg
| 5.95
| 10.87
| 0.96
|
AMOXYCILL
| 20
|
Captopril Tabs 12.5mg
| 3.20
| 5.49
| 0.98
|
ACE HEMMER
| 30
|
Captopril Tabs 25mg
| 4.51
| 7.04
| 1.06
|
ACE HEMMER
| 30
|
Captopril Tabs 50mg
| 7.38
| 9.91
| 1.75
|
ACE HEMMER
| 30
|
Cimetidine Tabs 400mg
| 7.87
| 15.95
| 1.21
|
ALTRAMET
| 30
|
Frusemide Tabs 40mg
| 1.33
| 3.33
| 0.25
|
FURO
| 30
|
Ranitidine Tabs 150mg
| 19.62
| 21.25
| 13.82
|
AZURANIT
| 60
|
Ranitidine Tabs 300mg
| 19.18
| 19.01
| 13.82
|
AZURANIT
| 30
|
| | |
| | |
Annex B
PATIENT PACKS IMPLEMENTATION
Thank you and the other signatories for your 7 March letter
with its commitment to the principle that information to patients
on their medicines should be made available in manufacturers'
(patient) packs wherever possible. I share this commitment and
welcome your offer to work together to achieve this change.
I endorse the broad timescale for the full implementation
of the move to patient packs and agree with the general wish that
a formal start should be made this Spring. I have therefore asked
officials to begin consultation immediately to pave the way for
change to the Prescription Only Medicine Order.
As your letter points out there are still important practical
issues to be finally resolved—the degree and timing of translation
required to ensure that patient information is ultimately available
at the point of dispensing for all prescribed medicines; stock
management issues in the community pharmacy; details about the
supply of leaflets and the monitoring and progressive adjustment
of the implementation programme through to its completion. Over
the next few days officials will be writing to the appropriate
organisations about these issues.
My purpose in writing now is to confirm the Government's
[unequivocal] support for an incremental move to supply medicines
in patient packs and to let you know that further discussion of
detail will take place against that background.
Gerald Malone
MEETING OF THE PATIENT PACKS JOINT WORKING GROUP ON 17
JUNE 1997
| Present: | |
|
Department of Health
Mr J Barnes
Dr P Clappison
Mr J Thompson
Mr K Childs
Mr B Dyson
Mr C Andrews
Miss H Robinson
Ms J MacDonald
Ms A Armstrong
| ABPI
Mrs F Charlesworth
Mr J Bowler
BGMA
Mr W Smith
SPGC
Dr C Virden
| PSNC
Mr W Dove
Mr S Axon
RPS
Mr R Odd
GMSC
Dr P Fellows
Dr J Chisholm
|
| | |
PURPOSE OF
MEETING
1. The purpose of the meeting was to take stock of developments
since the last meeting of the Group on 30 May.
PSNC PROGRESS REPORT
2. Mr Dove reported that:
— PSNC and the Department had reached agreement
on the Container Allowance arrangements which would be
introduced with patient packs. This was confirmed in his letter
to the Department of 17 June;
— at a meeting with the Department on 12 June, much
progress has been made towards resolving the outstanding residual
stock issue. PSNC would write shortly to the Department outlining
how they had arrived at their estimates of residual stock costs.
The Department had agreed to give some thought to how extra storage
space needs of pharmacists might be reflected in the final package;
— PSNC had considered the 6 June draft of the new
dispensing and reimbursement rules. There were some points of
detail that required further discussion with the Department such
as definition of the "standard pack". To ensure that
patient pack implementation remained on course for September 1997,
the final wording of the rules (and how they would be reflected
in Regulations and the Drug Tariff) would need to be put to the
9 July meeting of the PSNC.
Action: Department would take stock of position on dispensing
and reimbursement rules by 3 July. Papers sent to PSNC would also
be copied to JWG members.
MATCHING PRESCRIBING
AND PACK
SIZES
3. The current pack size exercise (paragraph 8 of the
note of 30 May meeting) had now been completed. A proportion of
products were to be referred to Dr Clappison's group for a further
professional view. Copies of products, with pack size guidelines
(including those referred for a second opinion) would be sent
to GMSC, PSNC and copied to industry at the same time.
INFORMATION AND
EDUCATION PROGRAMME
4. Mrs Charlesworth had received comments on the revised
draft of the CASE document from some but not all members of the
Patient Packs Education Campaign Sub-group (of the JWG). The Department's
publicity unit had advised that DH would be able to handle a distribution
of information to NHS professionals. A representative from the
unit would be at the next meeting of the Education Sub-group on4
July (2.30 at the ABPI).
5. ABPI had kept GP and pharmacy computer software organisations
and wholesalers informed about developments on patient packs.
It would be important to ensure that these received information
on the phasing timetable as soon as this was finalised.
PPA
6. The Department's dialogue with PPA was continuing
a very detailed level in order effectively to translate the reimbursement
rules into a workable system for the PPA to operate. Members would
be kept informed of progress.
PHASED PROGRAMME
7. MCA had still to resolve some outstanding issues on
the revised programme. In the meantime copies of the current proposals
(not the final version) would be sent to JWG members (attached).
SPARE LABELS
AND LEAFLETS
8. On 21 May Mr Barnes had written to Dr Read, of the
ABPI, explaining that although no immediate legal requirement
would be placed on companies to supply spare leaflets and labels,
it was essential that pharmacists, required to break packs, had
access to labels and leaflets for patients. Copies of Mr Barnes'
letter and Dr Read's response of 9 June had been circulated to
JWG members. GMSC thought that pack breaking was more likely with
particular products, such as Antibiotics. Mr Bowler said that
the ABPI fully recognised the potential problem for pharmacists.
He would take the matter away in order to develop a recommendation
to be put to a future meeting of the Working Group.
UK COUNTRIES
9. All agreed it was most important for all UK countries
to synchronise implementation of patient packs. The Department
would check with Scottish and Welsh Offices for a progress report
on this.
MONITORED DOSAGE
SYSTEMS
10. It was still unclear how patient packs would impact
on MDS. The Department would take the matter away and report back
at a future meeting of the JWG.
NEXT MEETING
11. The next meeting of the Group would be on Thursday
10 July at 2.00 pm in room 149 Richmond House.
DH International and Industry Division
June 1997
| Date of introduction of packs | MARCH
| JUNE | SEPTEMBER
| DECEMBER |
| 1997 | |
| Phase A
Antivirals
Cholesterol reducers
Systemic corticosteroids
Sex hormones and other gynaecologicals
Vaccines
Dermatologicals
| Phase B
Peptic ulcer
Cardiac therapy (some)
Antihaemorrhoidals
Antieoplastic and immunosupressant, excluding endocrine therapy
|
| 1998 | Phase C
| Phase D | Phase E
| Phase F-F1 |
| Antimigraine
Antispasmodics
Antidepressants
Antiasthma
Antidiarrhoeals and intestinal anti-infective
Antihistamines
Anxiolytics
Hypnotics
| Paracetamol-containing products
Aspirin-containing products
| Antacids and anti-flatulent
Musculoskeletal system
Gynaecological and anti-infectives and other urologicals
| Anti-diabetic therapy
Antihypertensives
Beta-blockers
Diuretics
Peripheral vasodilators
|
| 1999 | Phase F-F2
| Phase F-F3 | |
|
| Psycholeptics and psychostimulants
Systemic hormones
All other CNS
Endocrine therapy
Cough and colds
Nasal preparations and nasal decongestants
| General systemic anti-infectives
All other gastrointestinal tract
Mouth preparations
Sensory organs
Laxatives
throat preparations
Blood and blood-forming organs
Various (not falling into other categories)
| | |
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