Citizens’ access to pharmaceutical innovations

By Dolors MONTSERRAT, Spanish Minister for Health, Social Services and Equality

Providing healthcare and essential medicines to citizens is a priority for the healthcare systems of the European Union. For years, the only barrier to access to medication was obtaining a marketing authorization. However, different factors—such as globalization of the pharmaceutical industry, unrelenting scientific progress, citizens’ right to the best possible health results when they are ill, ageing, the challenges of rare diseases, and personalized or precision treatments— have made the sustainability of healthcare systems a new consideration that must be taken into account when addressing access to medication. To talk of innovation and of access to medication simultaneously is by no means contradictory. We must maintain our conviction and our drive to make innovation, access and sustainability compatible within healthcare systems, in the interests of our citizens.

Innovation in the pharmaceutical industry requires a suitable environment. The European Union must therefore offer the right conditions for innovation to take root and flourish in the region. For the purpose of this article, we will provide three examples of current mechanisms that help innovation to materialize and prosper in the EU. The first is the Innovative Medicines Initiative (IMI), a public-private initiative to foster development of improved, safer medication for our citizens. The second is Regulation No 536/2014 of the European Parliament and of the Council of 16 April 2014, on clinical trials on medicinal products for human use, which will be fully applicable in the second half of 2018. This regulation will make it possible for the EU to increase the number of clinical trials of medication that has been developed in Europe. This will benefit us all, by promoting a vibrant and active health science industry, but also by undertaking clinical trials in Member States, thus providing patients who have run out of options with a means of
access. The third instrument is the framework of aid that the network of European medicine agencies and the EMA itself offer to small and medium-sized enterprises, to maximize successful development of innovative products that can have a significant impact on the health of our citizens. The network’s Innovation Task Force, and EMA initiatives such as PRIME (Priority Medicines) aim to foster development of high-impact medication and attract capital from investors, to prevent a lack of experience or of investment from delaying the launch of a product or perhaps even keep it from ever reaching the market—something which can be prevented in the initial stages of development by proper regulatory support.

Once innovation has been achieved, attention must then turn to the instruments that enable access to medication, whilst
keeping in mind that this is not a case of all or nothing. Insight into medication grows as its development advances, allowing marketing authorizations to be issued. We must therefore make it possible for medication to reach the market as soon as possible, but with sufficient experience and knowledge to allow authorizations to be issued and subsequent decisions to be made. However, this does not mean that access should be delayed, rather that it should be appropriate to the level of insight into the medication. For this purpose, we have access mechanisms that can be bolstered, thus increasing Europe’s competitiveness as a hub for clinical trials, but also opening the door for initiatives such as compassionate use of medication that is being researched or authorization through managed entry schemes, including results-based payments and extensive use of records.


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