A group of global, regional and national palliative care organisations has urged governments and regulators to end the practice of pharmaceutical companies marketing sustained-release morphine and expensive opioid formulations, and to ensure the availability of generic immediate-release oral morphine for pain management.
Currently, oral morphine use in many low-income and middle-income countries (LMICs) is low due to regulations controlling narcotic and psychotropic substances.
Taking advantage of this, drug companies are selling costly, sustained-release opioids in such markets, civil society groups have said in The Morphine Manifesto released on 2 December 2023.
To correct this situation, reports The Lancet Oncology, the manifesto suggests national governments revise regulations restricting access to oral morphine, and facilitate its availability in public health institutions, before approving the marketing of more expensive opioids.
The manifesto, developed by Pallium India in collaboration with the International Association for Hospice and Palliative Care in Texas, USA, had been endorsed by 46 palliative care bodies by 12 December.
Unethical marketing practices and over-regulation of morphine for medical use are resulting in cascading impacts on patients, say palliative care experts.
“Western pharmaceutical companies use aggressive marketing techniques to convince ministries of health in LMICs to licence and import expensive opioid products, doctors to prescribe them, and patients to ask for them, even though they are no better and sometimes worse than morphine. While pharmaceutical companies increase their profits, many patients’ families are driven unnecessarily into debt,” Eric Krakauer (Harvard Medical School) commented in The Lancet Oncology.
“We can only assume the industry provides governments with incentives to distribute the more expensive, brand-name medicines since they have no incentive to produce and market generic morphine because it is unprofitable,” said Katherine Pettus (IAHPC, Houston, USA).
A 2023 WHO report, Left Behind in Pain, highlighted global inequities in access to morphine and other strong opioids for medical use.
In 2021, more than 80% of the morphine available (in weight) was distributed for consumption to high-income countries in North America and Europe.
The supplies are regulated internationally by the UN Single Convention on Narcotic Drugs and the Convention on Psychotropic Substances, and are subject to the laws of individual countries.
This makes the supply process cumbersome, requiring strong co-ordination across multiple government agencies. Any laxity in the process could disrupt the supply.
The challenge is to develop a balanced approach that plugs inappropriate use of morphine and ensures access to its medical use.
“We have been able to strike such a balance successfully in the Indian state of Kerala since 1998 when the narcotics rules were amended. Since then, the law has been amended at national level; palliative care has been included in the primary care system as well as in medical and nursing curricula. But there is still a huge implementation gap,” said MR Rajagopal (Pallium India).
In Uganda, multiple steps, like local manufacturing of liquid oral morphine, allowing specially trained nurses to prescribe morphine, providing government subsidies for morphine, and close monitoring of supply chains by prescribers, narcotics police, and health ministry officials, have helped prevent stock-outs and diversion of morphine, added Pettus.
Access to affordable oral morphine is also improving in Rwanda, Nepal, El Salvador and Vietnam. Innovative mechanisms such as pooled purchasing could help to overcome the hurdles to morphine access.
“The idea is that any country that can demonstrate a secure supply chain (to minimise the risk of diversion of morphine to non-medical uses) should be eligible to participate in pooled purchasing. This way, buyers would have leverage to negotiate down the price,” noted Krakauer.
Another approach, suggests Stephen Connor (Worldwide Hospice Palliative Care Alliance, London), is to start expanding access to morphine just for patients in palliative care, since “most of the problems we have seen are linked to too much use for chronic pain patients”. The larger issue, however, is ethical.
“As per The Morphine Manifesto, no country should allow sales of expensive opioid products unless cheap, oral immediate-release and injectable morphine are widely accessible. Individual governments could implement such a policy. Even better would be a global agreement.
“The pharmaceutical industry would dissent that its business is being unfairly impeded. So, the big question is, ‘should pain relief be primarily a profitable business or a medical and moral responsibility as well as a human right?’” asks Krakauer.
THE-MORPHINE-MANIFESTO-2023
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