a time-constrained environment. History has shown that it takes many years of continuous commercial production for a Mo-99 producer to eventually earn the right to be classified as a reliable supplier by the major radiopharmaceutical manufacturers.

Unfortunately even highly experienced producers are not immune to lapses in reliability and supply outages. For many years Nordion of Canada, for example, was considered to be the only reliable supplier of Mo-99 to the extent that most of the major generator manufacturers followed a strategy of single-source supply. But even though Nordion was technically a reliable producer, external factors such as labour disputes or inclement weather conditions caused supply from Nordion to falter from time to time.

For many years the major generator manufacturers steadfastly clung to their single-sourcing strategies with Nordion rather than moving to a more sensible multi-sourcing strategy and contracting a portion of their supply to prospective new entrants.

In the late 1990’s Mallinckrodt was the first major generator producer to “break rank” and in addition to commissioning their own Mo-99 production facility they realised the need to contract other Mo-99 producers into their supply chain. A logical choice of an alternative producer was IRE who was well experienced at that stage with an impeccable supply track record. Despite the demonstrated reliability of IRE, Mallinckrodt required the inclusion of yet another producer so as to cover all supply eventualities. This led to the establishment of the relationship between IRE and the fledgling producer NTP Radioisotopes of South Africa. A relationship which has, over the years gone from strength to strength and which today, some 20 years later, can offer a fully functional mutual backup arrangement. During the initial years of the relationship, while NTP was getting to grips with the complexities of Mo-99 production, IRE was frequently called upon to cover supply shortages from NTP. With the passage of time, NTP was able to improve production reliability, thereby enabling the two parties to be able to offer an assured (mutually backed up) supply of Mo-99 from two production facilities on two continents utilising some 5 different reactors. Over more than 20 years of this relationship there have been numerous instances where NTP and IRE have been able to avert global shortages, being the only operational global producers at various points in time. This was particularly the case in 2009 and 2010 during the extended NRU shutdown when NTP and IRE significantly increased production levels to mitigate against the global impact of the shutdown. Another example was in 2010 when the volcanic eruption in Iceland disrupted air transport between Europe and the USA; NTP and IRE joint customers were not impacted because US customers were supplied from South Africa while IRE secured supply to European customers.

The excellent working relationship which has evolved between the two parties over the years has enabled customers to experience a seamless supply from the two production facilities even to the extent that both entities utilise the same transport containers, greatly facilitating the handling of the product in the generator production facilities.

The key to offering such a mutual backup arrangement is that the two producers have to maintain a significant level of excess production capacity. This means that both producers must retain sufficient excess capacity so as to be able to honour their backup commitments in respect of their partner in the event of a planned or unplanned outage. More recently this concept has become the focus of attention at forums such as the High-level Group on the Security of Supply of Medical Radioisotopes (HLG-MR) and has been formally defined as Outage Reserve Capacity (ORC). The HLG-MR has, quite correctly, advocated that the maintenance of ORC adds to the costs of the Mo-99 producer which should be fairly compensated for this. Unfortunately this, together with the concept of Full Cost Recovery (FCR), has not found favour in the industry where the ongoing cry is for cheaper Mo-99.

Right now the Mo-99 market is going through an extremely interesting phase with a few remaining reliable commercial producers on the one hand and a range of prospective new entrants on the other hand.

Prospective new producers have generally been optimistic regarding construction time, costs as well as quoted production capacities. That said, one aspect which tends to escape mention is the time from initial commissioning until they will reach the status of “reliable producers”, ready to shoulder the formidable responsibility of ensuring on-time consistent deliveries. No hard and fast rule exists to forecast the time it will take for a producer to achieve supply reliability but empirical evidence suggests that this status is achieved in years rather than months after the first production of Mo-99 in a new facility. It is during this critical time that the new producers need the support of an experienced backup partner to support them during planned and unplanned outages.

Many of the major generator producers have made encouraging actions in support towards aspiring new producers by entering, somewhat prematurely, into supply contracts despite the fact that, in most instances, even the date of commissioning of the production facility remained ill defined. In order for new producers to honour these supply contracts they need the support of a backup reliable partner. Yet, this support is extremely problematic to achieve as the ORC of many of the existing reliable producers is already fully committed.

Up until now, new producers have been encouraged to develop novel methods for Mo-99 production and a number of entities have accepted the challenge, thereby accessing the associated financial support which has been made available. In a few years’ time, many of these producers will be able to manufacture product. It will be interesting to see whether generator manufacturers will actually be willing to contract supply from a new producer with no record of reliable supply and without the support of a backup partner. On the other hand, perhaps by then, reliability of supply will no longer be the watchword of the industry.