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Thanks to new scientific and technological developments and accelerated review by regulators, innovative medicines become available at a faster pace. Unfortunately, at the same time, the price of innovative medicines is rising at an unsustainable rate. The costs of new cancer drugs, for example, have doubled over the past ten years.1 Price setting is utterly lacking in transparency. The pharmaceutical industry, with profit margins of up to 40%2 and marketing expenses that far outweigh research and development budgets, often appears profit-driven rather than service-driven.
This situation has confronted policymakers with serious challenges, as they have to ensure the sustainability of healthcare systems while guaranteeing that patients can continue to benefit from innovative pharmaceutical care. The debate around affordability of innovative treatments is of special concern to haematologists. Haematology is a very research-intensive discipline, with a high success rate in delivering innovative medicines that can save or improve the lives of patients suffering from blood disorders. Many of these medicines, however, are marketed at a high price – increasingly to the point of becoming unaffordable.
While pricing and reimbursement of medicines in the European Union are competencies of the Member States, strengthened EU collaboration in this area is urgently needed. The European Hematology Association (EHA) is a strong proponent of coordinated action to: 1) curb drug prices; 2) increase the transparency and cross-EU harmonisation of pricing and reimbursement decisions; 3) engage in joint negotiations and joint procurement of essential medicines; and 4) strengthen EU co-operation in the field of Health Technology Assessment (which is increasingly used by Member States to guide reimbursement decisions).
While essential drugs are fast becoming unaffordable and most of basic and translational research continues to be taxpayer-funded, pharmaceutical companies continue to maximise their profits to sometimes unacceptable levels. In order to change this situation, a pan-European strategy is needed to reduce the prices of innovative medicines.
One key step would be to make a central EU authority responsible for negotiating fair, transparent and realistic maximum prices for newly approved, essential medicines. An option could be to assign this task to the European Medicines Agency which would then bear responsibility not only for approving new drugs for the European market, but subsequently also for setting price limits.
Equally important is support for publicly-funded trials, which will make the sale of approved drugs at cost price possible, speed up research (which will benefit from direct access to clinical trial results) and lower the price of post-patent biosimilars.
An initiative by the Benelux countries and Austria, aimed at joint negotiations of orphan drug prices with the industry, also deserves broad support. Because orphan drugs – medicines to treat rare diseases – are often considered too expensive to develop and produce by pharmaceutical companies, their collective procurement by a group of countries is potentially beneficial to patients who suffer from rare diseases, companies looking for substantial patient pools and public health systems with strained budgets.
Reducing the prices of new, essential medicines is a must for haematology as a highly innovative discipline and, most of all, for patients in need of access to the best and latest treatments.
1 WHO Europe. Access to medicines in Europe. March 2015:14
2 Amigobulls Inc. Key Financial Ratios 2015 per company. www.amigobulls.com/stocks. Retrieved September 2016