Over the past few years, the health policy landscape in Brussels has been characterised by the member states’ intense request for greater access to medicines. The primary focus has been on how prices could be reduced to increase access. However, drug shortages have equally remained on the radar.
In June 2016, the Dutch Council Conclusions on strengthening checks and balances on the pharmaceutical industry have stirred political developments that have led to the ongoing intellectual property incentives review, the health technology assessment legislation and the creation of further member-state initiatives aimed at achieving enhanced cooperation in pricing and reimbursement negotiations, such as the Valletta Group. In the meantime, the European Commission warns that drug shortages can have negative consequences for the health of patients.
Drug shortages: a global problem with no clear solutions
Drug shortages, a global phenomenon, have existed for a significant amount of time. From the US to Asia, there have been many cases of shortages of life-saving medicines. A decade ago, the US was concerned over drug shortages of cancer as well as cardiovascular medicines amongst others. On a global level, many markets and government policies have been failing to ensure adequate numbers of HIV/AIDS and Tuberculosis treatments.
The complexity of the phenomenon and multitude of causes have made the identification of the reasons for shortages extremely difficult. Some argue that the increased global demand and the constant need for an upgrade in facility standards have led to shortages. Another theory suggests that the expansion in the volume of products manufactured by the pharmaceutical industry has led to issues of having massive amounts of Active Pharmaceutical Ingredients and an expanding manufacturing capacity.
Additional factors to be considered include the existence of disrupting practices such as parallel trade. Parallel trade of drugs within the European Union is legal according to the rules governing the Internal Market. However, cross-border trade has been heavily criticised as a cause of drug shortages since it often re-directs the supply of life-saving drugs from lower income EU member states, where governments tend to set drug prices at a lower level, to higher income member states, such as Germany. As a result, poorer member states may be faced with shortages of high-quality life-saving drugs, whilst richer member states may enjoy larger healthcare savings where the margins of intermediaries so permit.
The importance of innovation for more access to medicines
Access to life-saving medicines is, and will continue to be, a priority given the significant unmet medical needs. The Commission and policy makers would therefore be well advised to consider the multitude and interdependency of causes that drive access to medicines. It will be key not to reduce the ongoing debate on access to a review of IP incentives, which is currently being driven by the pricing and access discussions taking place in member states. Too much is at stake: a simplistic debate and seemingly simple solution can easily threaten the appetite for the development of medicinal innovation in Europe and jeopardise Europe’s competitiveness and ambition to stay at the innovative medical forefront.
Ensuring both financial and intellectual property incentives for the industry remain a key driver for ever bolder innovations of life-saving drugs. For example, most recently, a cutting-edge innovation regarding CAR-T cell therapies has been hailed as a possible option to effectively treat a range of types of cancer.
New Commission to solve drug shortages?
Regardless of any rumours about the fate of DG SANTE and the potential dispersion of health competencies, the future Commission is expected to continue to play a coordinating role in member states` request for improving access to medicines. Accordingly, it would be no surprise if the incoming Commission were to reinvigorate the Public Service Obligation (PSO) principle laid down in article 81 of Directive 2001/83/EC for the maintenance of medicinal products across the supply chain.
Even though health is a competence shared between the European Commission and the member states, it is well conceivable that, by way of a revision of the Directive, more stringent enforcement measures to secure continuous supply of medicines could be enacted.
The EU Year of Change promises to bring a new wave of policy-making in healthcare with the sustainability of the healthcare systems and access to medicines being at the core of the health-related debates.
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December 19, 2018
November 28, 2018