NIPinF Editor Laure James talks exclusively to some of the biggest names set to be affected by the controversial generic tendering proposals in Northern Ireland.

Mark, who is unable to find major fault with the existing generic supply system, added that at present, there is choice and competition. “If you artificially restrict the market and drive out suppliers through a tender process then you become dependent upon one or small number of companies,” he explained.
“That clearly runs the risk of product shortages if, for whatever reason, those chosen companies cannot meet demand. If that happens then either the patient cannot get the medicines they need or the more expensive ethical product will need to be provided. In other words, the unintended consequence might be increased cost to the DHSSPS, not a cost saving as they anticipate.

“Even if that situation does not arise, I am far from convinced that over the medium term therapeutic tendering will actually save the Department money. The risk is that the DHSSPS becomes over-reliant on a few suppliers who would then be in a position to drive prices up.”

There is also a concern among manufacturers that the successful tenders will be those with the lowest prices, which can of course encourage a misleading focus on product cost instead of the total cost to serve. “In other words, getting the product in the hands of the patient in a safe, reliable and timely manner,” Mark said. “Do we really want to move from the current levels of service to a situation where there is perhaps increased stock holding, minimum order quantities or less frequent deliveries?”

It is thought that primary care generics will be procured in Northern Ireland under a central tendering system from April next year. So how does the process work? After having recently met with Mark Timoney, senior principal pharmaceutical officer at the Department and consultant on the tendering programme, NIPinF learned that product selection will be standardised and manufacturers will bid for a contract to supply the selected product for a three year period, at a price negotiated with the Department, meaning that community pharmacy will also be purchasing these drugs at a fixed price.

The initiative will use a model referred to as STEPS, an acronym for Safe, Therapeutic, Economic, Pharmaceutical Selection, to identify which drugs the Department wishes to procure. Risks are said to be minimised by pre-qualification of generic manufacturers to agreed criteria and quality and risk evaluation of products, followed by cost analysis to select the most economic samples.

Mark conceded that it is “entirely laudable” that the DHSSPS should consider at ways of achieving cost savings and ensuring value for money in the health service, describing it as “an outrageous neglect of duty” if they did not do so. “However, I remain unconvinced of the compelling need to implement therapeutic tendering or that it will actually deliver any tangible benefit,” he said. “Perhaps the DHSSPS might want to consider putting the whole exercise on hold whilst it conducts a review with input from relevant stakeholders. We at AAH would be more than willing to work with the Department to find the best solution for patients in Northern Ireland.”

Mark is not the only one who remains more than unconvinced about these proposals. The Pharmaceutical Contractors’ Committee have voiced their ‘grave concerns’ about tendering for generics, claiming the Department have disregarded their strong opinions. “We believe this proposal is misguided and ill-conceived and, worse still, officials seem intent on railroading it through with no regard for our legitimate concerns or for the risks to the supply chain that it poses,” Terry Hannawin, PCC chief executive said. “Contrary to the impression that has been given, the PCC has not at any stage been consulted on this proposal by the Department. We find that not only disappointing but insulting. Does the Department believe that the views of pharmacists and their representative body do not matter?”

“The supply chain arrangements are secure, reliable and safe,” he added. “Any proposal for radical change such as this needs to have been carefully developed, risk assessed and the case for change needs to be proven in advance. The Department made a similar change in relation to the supply of wound care products in July 2007. That has resulted in 95 per cent of the wound care products available in the UK not being available in Northern Ireland. That’s bad news for the NHS and for patients in Northern Ireland, and it bodes ill for this even more radical proposal.”

The negative reaction these proposals have caused could also spell difficulty for the continuing contract negotiations, which have already encountered problems. “The generics central tendering proposal is only part of a wider picture,” Terry added. “We have been seeking to make progress in negotiations with the Department over a new pharmacy contract. We are unimpressed by the Department’s stance in those negotiations, which has resulted in progress being slower than we wanted. It means that the public who value their pharmacy so highly are being deprived of a new range of pharmacy services that can enhance their health and well-being.”

Furthermore, although the full extent of Category M’s impact upon contractors in Northern Ireland is unclear, it is another prickly subject for PCC. “We remain extremely concerned over the effects of Category M,” the chief executive continued. “Pharmacy contractors in Northern Ireland are feeling the full force of Category M price reductions and it is having a savage impact. That is unfair and unsustainable and we call on the Department to address this matter fully and as a matter of urgency.

“We expect the Department to consult us and listen to our concerns over the generics central tendering proposal. We remain willing to work in collaboration with the Department on issues concerning the new contract and on Category M, but collaboration is a two-way process and we need to know that they are prepared to listen and act on our concerns.

“I will be writing to all contractors in Northern Ireland shortly to provide an update and more details on each of these matters.”

Terry concluded by reiterating his position, insisting PCC would oppose the plans for generic tendering and appealed to the Department to reconsider. “We have commissioned an analysis and critique of the proposal from an independent world-leading expert,” Terry said. “We look forward to discussing the outcome of that work with the Department. We hope they will be prepared to listen.”

However, the system itself has been brought into question since neither the ABPI nor the British Generic Manufacturing Association (BGMA) were consulted when bidding began earlier this year. When invited to respond, the Department expressed their disappointment at the negative responses towards the proposals and promised to discuss concerns with interested parties, including the PCC, in due course. "The Department is extremely disappointed at the position taken by PCC,” a spokesperson explained.

“We have been encouraging a collaborative approach to a range of developmental initiatives and unfortunately a number of inaccuracies in the statement have the potential to mislead. We will be taking up with PCC all of the points raised in their statement.

“The Department places the highest priority on the modernisation and development of community pharmacy. We look to the new contract as the key vehicle for delivering these. We have made strenuous efforts to work with PCC in the context of the new contract and have, for example, made numerous offers to PCC over the course of the past year on the development of patient focused services.