The effectiveness of en masse withdrawal. An untrusting customer’s run on the bank? A vociferous workers’ union strike? A globally observed ethical boycott? None of the aforementioned attract welcome publicity, but what if your controversial initiative faces virtually unanimous opposition scarcely moments after its unveiling?

The proposed tendering programme for generic medicines in Northern Ireland has been lambasted as perhaps one of the most disastrous concepts ever to fall out of Castle Buildings but before sensationalism strangles this article, it is time we heard from the manufacturers. Initially, some manufacturers agreed to get involved but NIPinF can now exclusively reveal that yet another two major generics firms have backed out of proceedings.

Citing the risk of “serious disruption” to the supply chain and compromised patient safety as their reasons for withdrawing from the primary care tender, directors at Actavis UK have finally severed their ties with this programme. Michael Cann, commercial director said that many factors contributed to this move. “This is not a decision we have taken lightly,” he said. “To date we have remained within the tender process to better understand the objectives of the Department as well as its more detailed proposals as to whether such an initiative could work. We now believe that the proposed tender has the potential for serious disruption to the generic pharmaceutical supply chain and therefore put patients at risk of not being able to get their usual medicines.”

Michael added that Actavis had also taken into consideration the other stakeholders involved in the supply of generics in Northern Ireland and the potential impact upon them. “In particular we have developed a greater understanding of the impact on independent retail pharmacy,” he said. “We raised a number of more detailed issues with the DHSSPS that to date we consider unresolved.”

Genus Pharmaceuticals followed shortly afterwards, with managing director Peter Ballard commenting; “The risks to patient supply are too great and Genus and BGMA do not believe this system can work at this time. We are totally in favour of Government getting medicines at the fairest, best or most competitive prices so as to be able to treat as many patient as possible with the funds available. However, this plan for primary care tendering is not workable at the moment.”

These include a lack of consultation between all stakeholders, a need for clear understanding of the impact on pharmacy reimbursement and purchase profit, a need for transparency over the commercial model that will operate in Northern Ireland post tender – specifically the potential for arbitrage giving rise to product shortages – and the current ambiguity over the impending changes to PPRS.

“Actavis continues to fully support the DHSSPS’ aims relating to the supply of generic medicines which include enhancing patient compliance, ensuring the provision of high quality medicines and securing the best value for money, but these can surely only be hindered if competition is removed,” Michael added. “We have therefore given commitment to the DHSSPS and all other stakeholders in Northern Ireland that we are prepared to work with the Department to help them build a framework for the supply of generic medicines to Northern Ireland that will work for all.”

A spokesperson for the Pharmaceutical Contractors’ Committee said that since the news of Actavis terminating their involvement had only just emerged, they would be unable to comment at this stage. However, the move will no doubt be welcomed by the majority of contractors, including Ulster Chemists’ Association president Paul McDonagh. “The UCA fully supports Actavis’ decision to pull out of the generic tendering process,” he said. “We don’t believe the scheme is workable and with two major suppliers now no longer involved in tendering, this will put further pressure on the manufacturers who are currently involved and I don’t believe that sufficient drug supply can be achieved if shortages could be encountered, leaving patients at risk.”

Back in August, NIPinF exclusively revealed that Teva UK had shunned the tendering plans and there certainly is no indication that they regret their decision. As Teva see it, Northern Ireland could be on the brink of a chance that could unfurl a complete transformation of the profession, but have offered assurances to their customers. “We took the decision not to submit a bid in the primary care tender process but did not take this decision or our responsibilities lightly,” explained Kim Innes, commercial director at Teva. “We acknowledge the Department’s concerns that have arisen because of an increase in generic prescribing as a result of the ‘Go Generic’ initiative. However, generic prescribing in Northern Ireland remains at a lower level than that in the rest of the UK and we believe we have some valuable insight into this and some alternative suggestions that could help alleviate the government’s concerns. We have offered to work with the DHSSPS to help achieve its goals.

“Importantly, we continue to support you, our customers. The support we, and our Northern Ireland territory managers, have received from our colleagues in the province has been immense. Notwithstanding the fact that from April 2009, Teva may no longer be a part of the makeup of the pharmacy industry in Northern Ireland, we remain committed to helping maintain a vibrant pharmacy industry.”

Kim has also spoken out strongly against the proposals within her role as chair of the British Generic Manufacturers Association (BGMA), explaining that three separate requests for an audience with Health Minister Michael McGimpsey have been declined. “The BGMA has worked closely with the authorities in England and Wales to agree a system for the reimbursement of medicines in primary care that delivers the lowest prices in Europe,” she said. “Our requests for a meeting to similarly advise Minister McGimpsey how to reduce costs effectively have been refused whilst the Department presses ahead with its own, unworkable plans. These are so unrealistic that some of the biggest suppliers of medicines have simply walked away and turned down business rather than try to make the unworkable work.”

Manufacturers Lexon also believe that generic tendering is not in the interest of Northern Ireland pharmacy. Anup Sodha, a director at the company, said he was apprehensive from the outset. “When the initial paperwork was issued, Lexon did consider the possibility of becoming involved with the distribution process of tendered generics although the Department did not invite us to discuss this further,” he said. “When we learned that other manufacturers were not tendering we admired their resolve because I certainly do not believe that the process is in any one stakeholder’s interest, including patients. My strong feeling is that if anybody is tendering that this should be made publicly known to prevent further confusion among customers.

“Pharmacists were not involved in any consultation but this is no reason for them to be without an alternative. Lexon will continue to support both the Department in its wider objectives when it comes to increasing the prescribing rate of generics and to support customers in Northern Ireland wherever and whenever possible.”

The Department is acutely aware of the obstacles although has given no indication the plans will be scrapped altogether. “While the project oversight team has worked to meet a defined plan of objectives, some unavoidable delays have resulted in delaying completion of the evaluation and adjudication parts of the exercise by some weeks,” a spokesperson for the Department said. "DHSSPS has strenuously emphasised to all stakeholders that this integrated tendering exercise is designed to inform improvement in the quality and safety of generic medicines management arrangements as we experience rapid increase in uptake of generic medicines in both primary and secondary care sectors.”

A consultation exercise to identify options for implementation will be undertaken with stakeholders as part of the explorative exercise, the spokesperson continued, although it is still unsure whether community pharmacy will be represented during these talks.

"The DHSSPS’ rationale to address concordance, consistency and cost-effectiveness agenda around generic medicines has been applauded by the industry both publically in the press and in all correspondence addressed to Minister to date."