The European Association for the Study of Obesity, the voice of 20000+ Obesity specialists across 36 WHO EURO Region Member States is calling for the European Medicines Agency and national regulatory authorities across EU27 to review their governance and practices which appear to be leading to breech of the rules pertaining to provision of suitable alternatives which are at least equally effective,
EASO is concerned that the European Medicines Agency and related national regulatory authorities’ (European medicines regulatory network) governance is having a negative impact directly on people already under pharmacological treatment for obesity. This is of particular concern, considering the ongoing medicines shortages crisis in EU27,
According to EMA rules, when there is a medicines shortage, triggered by market forces, safety or other consideration, measures to allow alternative medicines or suppliers to be used should be taken into account as well as to ensure that solutions encompass suitable alternatives which are at least equally effective.1
Although pharmacological therapies are highlighted here, it is clear that obesity treatments and long-term management ideally involve a number of interdisciplinary interventions including psychotherapy, therapeutic movement and therapeutic nutrition as well as bariatric surgery.
EASO has been concerned for some time about the highly limited availability of obesity-specific authorised pharmaceutical treatments, which are according to the international guidelines the recommended additional therapies when lifestyle interventions are not effective enough. In light of the latest development in the face of an Article 20 Procedure being instigated against the manufacturers of Naltrexone/bupropion (brand name Mysimba), the situation is reaching crisis point. Not only have the other pharmacological “suitable alternatives” been issued with major shortage warnings, but other non-pharmacological treatment pathways are routinely excluded from health systems across EU27.
In light of the potential breech of EMA Rules on provision of suitable alternatives which are at least equally effective, EASO calls on the EMA, National Medicines Agencies as well as pricing and reimbursement agencies to:
- Formally review EMA policies which are acting as a discriminatory barrier to the legal rights of people diagnosed with obesity to accessing effective treatments according to current guidelines
- Permit a temporary “on-label” status for those already prescribed naltrexone/bupropion or liraglutide 3 mg (brand name Saxenda) to be prescribed available GLP1 agonists already on the market to equivalent dosage efficacy under the principal of “compassionate grounds” or “medical need” as a legal basis.
Specifically in relation to the naltrexone/bupropion (Mysimba) Article 20 procedure and governance matters pertaining, EASO calls on the European Commission, the European Medicines Agency and National Medicines Agencies across EU27 to:
- Provide clarity on why the non-pharmacovigilance Article 20 has been initiated in the absence of evidence to suggest a change in the positive risk balance.
- Investigate to what extent the Article 20 procedure has been instigated in accordance with EMA trust procedures, competing interests and the appearance of conflict of interest
Contact:
Jacqueline Bowman-Busato
Head of Policy
EASO
Email: jbowman@easo.org | Tel: +32 468 222 386
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NOTES FOR MEDIA
About EASO – European Association for the Study of Obesity
Established in 1986, EASO is a federation of professional membership associations from 36 countries. It is in official relations with the WHO Regional Office for Europe and provides Expert Secretariats to the European Parliamentarian Interest group on Obesity & Resilient Health Systems as well as for the OPEN-EU (Obesity Policy Engagement Network – EU hub). EASO hosts the annual European Congress on Obesity (ECO).
EASO is the voice of European obesity professionals, representing a community of over 20,000 scientists, health care practitioners, physicians, public health experts, early career researchers and students.
EASO works across three priority areas: research, education and policy.
- International guidelines1,2 on obesity recommend to consider pharmacotherapy as part of a comprehensive strategy of obesity management, when lifestyle interventions are not effective enough for an individual patient.
- Naltrexone/bupropion (brand name Mysimba) is one of only five pharmacological therapies specifically authorised for the treatment and long-term management of different types of obesity along the life course within EU27.
- Other pharmacological therapies which are specifically authorised for obesity AND which could be considered as a “suitable alternative” under EMA Rules include Liraglutide 3 mg (brand name Saxenda) and semaglutide 2.4 mg (brand name Wegovy). Both of these have either been issued with a shortage warning and/ or have not been commercialised by the manufacturer despite being authorised by the EMA.
- Orlitstat (brand name Alli/Xenical), although authorised to treat obesity, is not considered as being as effective on average as naltrexone/bupropion (Mysimba). Setmelanotide (brand name Imcrivee) is only indicated for specific types of (rare) genetic obesity.
- Naltrexone/bupropion has de facto been in circulation servicing a patient population of in excess of 100 000 patients across the EU27 for 10 years without MACE occurrences. EASO is already starting to receive notifications of shortages of naltrexone/bupropion an anecdotally from countries directly affected by this development.
What is obesity?
Obesity is defined by the WHO as a chronic disease characterised by abnormal and/ or excessive fat accumulation that may impair health. (ICD11). The WHO classified obesity as a disease in 1948.i
In layman’s terms, obesity is the malfunctioning of the largest organ in our body; adipose tissue.
The European Commission has adopted the WHO definition of obesity and built upon it; defining pre-obesity (overweight) and obesity as:
“A medical condition marked by an abnormal and/or excessive accumulation of body fat that presents a risk to health. Obesity is a chronic relapsing disease, which in turn acts as a gateway to a range of other non-communicable diseases, such as diabetes, cardiovascular diseases, and cancer.”
Obesity prevention | Knowledge for policy (europa.eu)
References
1 European Guidelines for Obesity Management in Adults. Volkan Y. et al, Obesity Facts 2015
2 Obesity in adults: a clinical practice guideline. Wharton S. et al, CMAJ, 2020