As a whole new approach in illness treatment, personalized medicines will necessarily create new challenges for the whole healthcare system.

From that perspective, personalized medicines are challenging our social security systems. The initial decisions of the competent national authorities regarding the reimbursement of one specific personalized medicine gives us a first insight into the hot topics our social security systems will be facing.

ChondroCelect®, an advanced tissue-engineered technology which is used for Characterised Chondrocyte Implantation (CCI) articular cartilage repair, has been developed by TiGenix. It was the first medicine fully licensed in EU countries as an Advanced Therapy Medicinal Product (“ATMP”), in October 2009. It took at least two years before the first decisions of the competent authorities of Member States on reimbursement were taken. At this stage, the product is reimbursed, under strict provisions, in Belgium, Germany, Spain, the Netherlands and the UK. The reimbursement was rejected in France in 2013.

Common to those decisions – even the French one – is the impact on the decision-making process that such new products have.

Reimbursement of personalized medicines challenges healthcare authorities to use their common standards on reimbursement which were developed for standardized mass production to evaluate ATMPs. Indeed, personalized medicines are still medicines and can only be reimbursed as such. They are industrially prepared or, at least, manufactured by a method involving an industrial process. At the same time, personalized medicines share some of the characteristics of the magistral formula: the product is tailored to the individual patient. Therefore, Member States rejected “standard” reimbursement and opted for, where applicable, a contractual scheme.

Given the cost and uncertainty of such treatments, their reimbursement is not in line with standard social security schemes. Indeed, budget estimates are not sufficiently predictive and most public authorities will apparently foresee a risk-sharing scheme. In Belgium, for instance, the reimbursement will be void in the case of treatment failure.

Apart from those technical responses, we welcome a more ethical debate raised by the risk-sharing scheme: how to balance “individual cost” against “social cost”? Social security raises the fundamental question of distributive justice (fair distribution of scarce resources). Considering the costs of personalized medicine, how will society handle those choices: is personalized medicine sustainable, given its cost? Can healthcare systems afford such costs for everyone? Do we have to create risk categories? This debate is yet to come...

Besides the reimbursement issue, personalized medicine will raise new questions regarding our public health systems.

The regulation of public health is characterized by the distinction between different medicinal products (drugs, medical devices, advanced therapies, investigational products, etc.) and by healthcare providers’ different roles (physician, industry pharmacist, hospital pharmacist, etc.).

Personalized medicine is likely to blur those borders.

Given the borderline nature of the classification of personalized medicines (between pharmaceutical products and the magistral formula), the respective roles of the industry pharmacist and the hospital pharmacist tend to merge. However, under the current standards, the (industrial) production of medicines is merely separated from any direct delivery.

Similarly, the distance between the research sector and direct care is reduced.

Personalized medicines raise fundamental issues about the role of industry in providing healthcare.

Introducing new standards in the production and delivery of those products is likely to resolve most of the questions raised above. It is likely that personalized medicines will only last if, and only to the extent that, the drafting of new standard schemes for healthcare provision is implemented.