The high cost of pharmaceuticals has been gaining increasing attention as a threat to both healthcare systems and patients’ access to care globally. This GaBI issue contains articles focusing on the fact that generics and follow-on biologicals have yet to achieve their potential to mitigate these costs in most if not all countries.

In an Original Research Godman et al. present pricing data from 25 European countries for oral cancer medications. While they found considerable price reductions for some generic drug products, the reductions were neither uniform for either individual products or between countries. Interestingly the savings did not seem to be related to population size or indications; suggesting that some price control approaches are more effective than others despite similar market forces. They also mention the fact that price increases were also seen for off-patent cancer medications after changes in manufacturer. This behaviour has been even more evident in the US where certain companies have greatly increased the price of off-patent generic medications. The chief executive of a company which increased the cost of a decades old (non-cancer) generic antiparasitic drug (pyrimethamine) from US$13.5 to US$750 per pill was recently convicted of federal fraud charges. While the conviction was not a direct result of these price increases, the case demonstrates the potential negative economic and patient access impact of single producer of generic drugs. Despite this conviction, governments and patients remain vulnerable to such behaviour. Godman et al. found some ‘change of manufacturer’ related price increases for off-patent cancer medications but state that such increases were ‘now stabilizing’ and that countries were ‘starting to address’ such increases. However, unless or until such predatory pricing behaviour is prevented, healthcare systems and patients will continue to be threatened by the potential for single manufacturer companies to unjustifiably raise prices. I suggest that all countries will need to pass legislation to control such behaviour and/or that individual countries or groups of countries should begin to produce their own essential but single manufacturer pharmaceuticals. Interested readers are directed to both the last article in this issue and an article published by the Guardian which is available at: https://www.theguardian.com/sustainable-business/patent-wars-india-takes-on-big-pharma. Local production of such drugs ensures patients access to reasonably priced, off-patent medications and is already being done in some countries, e.g. Iran and Cuba, where local laws and regulations allow it. India has taken a related but alternative route to providing access to affordable generic drugs. Finally, the non-profit biotech company recently established by Bill & Belinda Gates Foundation offers another potential approach to this problem, especially for tropical and neglected diseases.

Physician reluctance/lack of trust is another force opposing the use of off-patent drugs. The Review Article in this issue by Castañeda-Hernández et al. discusses the regulation, naming and use of follow-on biological treatments of an orphan, rare disease, i.e. Gaucher disease. These authors question both the naming, regulatory approval, and selection of a follow-on enzyme replacement therapy (imiglucerase) which, despite being approved in some other countries, does not meet some requirements, e.g. WHO – World Health Organization, to be considered a true ‘biosimilar’. The authors’ opinions represent a position statement of the Grupo de Especialistas Médicos en enfermedad de Gaucher (Group of Medical Specialists on Gaucher disease). The authors base their concerns on their opinion that, ‘comprehensive data on the quality, efficacy and clinical safety’ do not exist for the follow-on product, i.e. Asbroder, and that, ‘equivalent efficacy and safety following treatment switching to Asbroder have not been proven sufficiently’ to justify its identical naming or use. Such skepticism, justified or not, is common on the part of clinicians who are often reluctant to change practice, especially one which provided hope where none previously existed. However, lack of proof is not proof of lack. When data are limited but do not show a problem, some will conclude that nothing should change until more data are available. Parents and patients will make decisions based on what they feel is best for their child/themselves and economic reality. Clinicians should make difficult decisions based on what is best for all patients, not just their own patients who can afford a more expensive choice. Regulators must also make decisions based on prevailing legislation and economic considerations. Unfortunately, all must often make decisions based on limited data. Because of this, it is useful to have country or region specific ‘best practices’ to guide regulatory decisions. This is the motivation behind GaBI educational conferences as described in the following meeting report.

In this Meeting Report, Laslop et al. describe the 2nd MENA Stakeholder Meeting on Biosimilars in 2018. This was only one of many such meetings devoted to helping regulators identify best practice methods to regulate follow-on biosimilar products. This requires regulators to explain their approaches to evaluating biosimilar products to stakeholders, e.g. pharmacists, clinicians and patients, as well as to listen to clinical challenges and concerns faced by clinicians and patient groups. Any potential healthcare savings will only be realized when all stakeholders are involved in and understand the viewpoints of others. The report presents in detail the structure, content and conclusions reached at this meeting.

The Abstracted Scientific Content summarizes a manuscript published by Conti et al. (J Pharm Policy Pract. 2018; 11:29). The original article (research for which was funded by the Commonwealth Fund and the American Cancer Society) discusses the rapidly rising costs of generic drugs in the US and the many legislative initiatives begun to control these increases. The authors concluded that ‘rising drug prices indicate a need to revisit current policies for their potential to either control such costs or instead to have the unintended consequence of leading to even more widespread generic drug price increases’.

While I am hopeful that current efforts will be successful, I am skeptical that they will succeed given both market realities and the current administration’s actions to relax any and all regulations, no matter how important for public or patient health.

Professor Philip D Walson, MD
Editor-in-Chief, GaBI Journal

Disclosure of Conflict of Interest Statement is available upon request.

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