Shortages in supply of Medical Radioisotopes -The lobby to stop alternative technologies and price fixing and Iran?

The continued fragility of the supply chain has been demonstrated by the unplanned and ongoing (for the foreseeable future) outage at the HFR reactor in Petten. …… some partial provision of outage reserve capacity have alleviated the negative impact of the HFR loss, but difficult times lie ahead, when other reactors enter maintenance periods.

Image source ; Barack Obama’s foreign policy team knew that sooner or later they would face a crisis over Iran. Unfortunately for the new US president, the crisis is already upon them.

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The situation will deteriorate further with the expected permanent shutdown of the NRU (for 99Mo production) in 2016 and OSIRIS around the same time, …… This clearly demonstrates the urgent need for governments to remove subsidies from the market and for supply chain participants to fully implement the HLG-MR policy principles in a timely and consistent manner.

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There are also other new projects for 99Mo/99Tc production capacity (e.g.Australia, Canada, People’s Republic of China,Republic of Korea,Russian Federation, and the US) that could help create future global irradiation supply

However, this capacity must bebased on full-cost recovery to avoid over-capacity, which can only act to drive down prices to levels at which some producers will not be able to recover their costs.’

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However, without a (small) increase in the price for end-users, there is a risk that medical isotopes will continue to be undervalued, with negative economic consequences for the upstream segment of the supply chain as well. Again, little has been done by governments to address the issue of appropriate reimbursement, with the exception of Belgium and the US.More broadly, governments should continue to redefine the “social contract” with the medical isotope industry and help it move to sustainability, through appropriate incentives and effective regulation.

In addition, they should cease subsidising Mo production at existing reactors and refrain from doing that at planned new/replacement reactors or for alternative technologies, as this endangers the universal implementation of full-cost recovery and could create undesirable additional capacity in the supply chain.

Finally, judging by the few responses from generator manufacturers and end-users to the self-assessment questionnaires, there appears to be a disconnection between the upstream and downstream segments of theMo/Tc supply chain and uncertainty in terms of their commitment to applying the HLG-MR policy approach. The HLG-MR and its stakeholders need to engage downstream supply chain participants more effectively in the process of moving towards economic sustainability in the market. Otherwise, the future security of supply could be in danger.

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http://www.oecd-nea.org/ndd/reports/2013/implementation_hlg-mr_policy.pdf

NEA report – The Supply of Medical Radioisotopes

20 February 2013

The OECD Nuclear Energy Agency (OECD/NEA) and its High-level Group on the Security of Supply of Medical Radioisotopes (HLG-M) have issued the final report of the HLG-MR and a summary of the report.  This report provides the findings and the analysis of two years of extensive examination of the molybndenum-99/technetium-99m (⁹⁹Mo/^99mTc) supply chain by the HLG-MR and key stakeholders.  In addition, it includes a comprehensive policy approach to ensure the long-term supply security of these important medical radioisotopes, detailing the essential steps taken by governments, industry and the health community.

These documents are available here on the OECD/NEA website.

Medical radioisotopes

The use of medical radioisotopes is an important part of modern medical practices. Each year, over 40 million people around the world benefit from nuclear medicine testing. Medical radioisotopes are used in non-invasive nuclear diagnostic imaging techniques to help identify common illnesses such as heart disease and cancer at an early stage. They are used to track disease progression and provide predictive information about the likely success of alternative therapy. This information helps health care professionals to accurately manage diseases and to make informed medical decisions on treatment options such as surgical intervention.

Supply shortages

Disruptions in the radioisotope supply chain can interrupt the availability of medical testing for millions of patients around world. Over the last few years there have been a number of supply shortages of the most widely used medical radioisotope, molybdenum-99 (⁹⁹Mo), and its decay product, technetium-99m (^99mTc). With a half-life of 66 hours for ⁹⁹Mo and 6 hours for ^99mTc, these isotopes must be produced continually and used efficiently in order to meet demand. Until recently, five multipurpose research reactors, all over 45 years old, have been producing over 95 percent of the world’s supply of ⁹⁹Mo. These aging facilities face challenges in maintaining a consistent supply to the health community and will likely be retired from service within the next 15 years.

Securing the supply

At the request of its member countries, the NEA became involved in global efforts to ensure a reliable supply of ⁹⁹Mo and ^99mTc. The NEA established the High-level Group on the Security of Supply of Medical Radioisotopes (HLG-MR) in 2009. The HLG-MR is comprised of approximately 40 experts representing the governments of Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Japan, Republic of Korea, the Netherlands, Poland, the Russian Federation, South Africa, Spain, the United Kingdom and the United States, as well as from the European Commission, the Euratom Supply Agency and the International Atomic Energy Agency (IAEA). Members of the HLG-MR were nominated by governments and included experts from government agencies responsible for medical or nuclear policy, as well as from research and industrial organisations with interests in medical radioisotopes.

http://www.oecd-nea.org/med-radio/

Lutetium 177 Dotatate Supply

The BNMS has been made aware of a potential short-term difficulty in sourcing Lutetium 177 Dotatate for the treatment of neuroendocrine malignancy.

The BNMS are working with the Department of Heath, other professional bodies and with suppliers to resolve this difficulty.

http://www.bnms.org.uk/radioisotope-supplies/dotatate-supplies/lutetium-177-dotatate-supply.html

EANM: Update on DOTATATE shortage, February 19, 2013

“..Dr Anthony Goh Soon Whatt, senior consultant and head, Department of Nuclear Medicine and PET, SGH, said: “The substance is like a mini nuclear bomb that targets (cancer cells). The procedure is actually a very elegant way of killing the cancer cells.”

In 2011, Dr Goh led a team of nuclear-medicine doctors, oncologists, nurses, scientists and laboratory specialists to Germany and Austria to learn about the treatment at hospitals there. The treatment has been available in those countries for eight to 10 years.

The team learnt about the equipment needed, the chemicals used and their side effects, and recovery care. For example, because the chemical used can damage the kidneys and cause nausea and vomiting, patients have to be given preventive treatments before the radioactive treatment can be administered.

As of early January, more than 10 patients have undergone the radioactive treatment at SGH. Some have had more than one cycle of treatment and all of them have experienced a better quality of life, said Dr David Ng, Senior Consultant, Department of Nuclear Medicine and PET, SGH.

As neuroendocrine cancer cells tend to grow slowly, regular treatment will kill the cells as they surface. That means patients like Ms Zhang can enjoy a normal life without the ill effects from some forms of cancer treatments, said Dr Ng.

Ms Zhang said: “I’ve undergone three cycles of treatment and experienced almost no side effects. Chemotherapy wears me down but, with this treatment, I’ve been able to go swimming or shopping the day after.”

The long-term effects of the new treatment are still unknown, but Ms Zhang is taking this in her stride….”

May 8, 2013 - Posted by arclight2011 | Uncategorized