From Mr H. B. Davis, MRPharmS
SIR,—While I totally agree with the headline to Mr Cooper's letter (PJ, November 13, p783) "inexcusable problems", I unreservedly take issue with Mr Cooper's premise that "the changeover [to patient packs] has been badly handled by the Association of the British Pharmaceutical Industry and also the government". During the time of the inception of the patient pack initiative I was actively involved within the generic pharmaceutical sector attempting to ensure that as far a humanly possible our sector at least would be fully prepared from both a regulatory affairs perspective as well as the logistical perspective of ensuring sufficient quantity of all products were available in patient packs.
What is often forgotten is that the brunt of this reorganisation and cultural revolution fell mainly on the generics sector, remembering also that the community pharmacist needed to prepare his dispensary and ordering practices to accommodate a major increase in space requirements due to the volume increase of a patient pack in respect to a bulk pack. It must further be recalled that the branded sector was already 90 per cent converted to patient packs by mid-1998.
The original plan as proposed during the stewardship of the previous administration was for 12 phases of three months per phase starting from December, 1995, to spread the burden of patient pack introduction across all therapeutic areas, taking approximately three therapeutic areas per phase. However, to persuade and cajole all the competitive generic and brand companies to agree to a standard patient pack size among themselves and to harmonise within clinical guidelines laid down by a Department of Health clinical committee was a remarkable feat in itself which would have been impossible had it not been for the total co-operation of all concerned within the umbrella of both the ABPI and the British Generic Manufacturers Association.
However, continued procrastination by the Department of Health meant that the three-year changeover was first truncated to 18 months and then to five months and then buried under consultation letter MLX247.
What was the main stumbling block to all this obfuscation and inadequacy? The Government was naturally concerned that the public purse would not be harmed by European legislation (directive 92/27/EEC, labelling and package leaflets), to which it had agreed and signed up, and was required to implement by January 1, 1999. The previous administration agreed with the industry that patient packs were the only way forward to take on board all the required legislation, including that of product liability. There were also the in-built advantages of better patient compliance, less waste and improved patient safety. All this was required to be achieved under the Department of Health constraint of "cost neutral" commitment to the Treasury.
To pack any product, pharmaceutical or otherwise, in units of 28 where before the bulk pack was anything up to 5,000 units was bound to involve extra costs, although there were savings to be made by eliminating container allowances. The Department of Health allowed a reasonable notional average cost increase of 15p per patient pack to cover cartons, blister pack material, patient information leaflets, etc.
The industry calculated a worst case scenario of an added £20m cost to the Treasury, a minor increase in the £2bn annual drugs bill. However, the Government, in counting only the negative aspects and none of the positive cost aspects, calculated that the overall cost increase would be £60m over the first three years and £15m thereafter.
It has now become apparent, as the present Parliamentary "witch-hunt" is revealing, that a whipping boy needs to be found to disguise from the general public the total cock-up that has been made by certain executives within the Department of Health. My own experience indicates that even senior officials had not a clue how the Drug Tariff works. They were just too used to a highly competitive generic market sector delivering cost savings in an open market situation.
In the final weeks and months of 1998, when the generics industry as well as the ABPI, issued statements that with government backing or otherwise, they at least would comply with EEC directives and would unilaterally proceed to patient packs, the Department of Health commissioned the Medicines Control Agency to issue a consultation letter MLX 247 to request comments from all interested bodies as to how to proceed. All comments were in by October 23, literally 10 weeks prior to the deadline, giving no time for reasonable implementation - a time conservatively calculated as 18 months - but whose main proposals ignored with apparent disdain the outcome of three years' of discussion between industry and the Government. To the best of my knowledge the outcome of this face-saving consultation letter has yet to see the light of day!
May I assure Mr Cooper and all community pharmacists that the generics industry has exerted its very best efforts to ensure as comfortable a changeover as possible, but these efforts were no doubt dismissed by certain wraith-like senior Department of Health officials as merely a means to increase profits, without giving any thought to patient safety, patient compliance or, as now is apparent, product shortages.
Obviously, the loss by Regent Laboratories of its licence and the internal reorganisations within APS-Berk and Norton added a certain complexity to the market. However, I am totally convinced that if the Department of Health had the integrity and internal ability to progress with the original time-plan, and not consider their personal promotion aspirations and forget about their "jobsworth" culture, we would not be in the current predicament, which appears now to be costing the Treasury far more than the industry's worst-case scenario. I wonder now whether anyone within the Department has the courage and honesty to come forward and admit to being the one - or more likely, part of a kangaroo court subcommittee - who advised the Minister of Health not to proceed with the patient pack initiative as originally envisaged and who no doubt is currently sitting, rather uncomfortably, on the results of the consultation letter MLX 247.
Henry B. Davis
Chigwell, Essex