Manufacturing resilience: what it is, and why it’s a priority.

You may have noticed me talk about security of supply for medicines and manufacturing resilience recently, in the context of the EU pharmaceutical strategy currently being developed. This is a very complex and challenging topic when you get into the details, however simply put it is an opportunity to ensure we (meaning everyone involved in medicines from manufacturers to patients) do all we can to ensure high quality medicines are available for patients when they need them. This is the first time in more than 10 years that such a strategy document will have been published.

When it comes to medicines and treatment, patients across Europe should not have to suffer from border closures or manufacturing shortcomings which lead to crucial medicines not being available. They should be able to have timely access to innovative medicines as soon as they are approved. It goes without saying that the need for a joined up and updated strategy was put under the spotlight by COVID19 and the ensuing concerns about availability of medicines for European patients. It has also illustrated that the journey of a medicine before it reaches our shelf is a complex one involving many steps.

What do we need to address on a European level?

There are different elements in the process to be considered that would allow our industry, R&D and manufacturing to keep generic and innovative medicines at the forefront of patient care and fighting disease. These are (amongst others):

·        A supportive and predictable IP regime

·        A modernized regulatory framework

·        Stimulating investment in research and development but also in manufacturing

·        New pricing strategies that make medicines affordable, focusing on a value-based system as opposed to “lowest cost”

·        Ensuring sustainable policies for all: industry and healthcare systems

 What does this mean in practice?

 Take APIs, the active component of the drug that produces its intended effects. At Teva for instance, we produce 40% of the APIs for our European Medicines and 93% of our finished medicines in Europe. But this is not the global tendency.

Over the past 20 years, we’ve seen the ratio between Europe and Asia be completely reversed. For 1 out of 6 APIs needed in Europe there are no European Certificate of Suitability (CEP)* holders at all, while Asia is known for large volume APIs resulting in an imbalance.

We must first seek to understand why this trend developed, if we want to bring about a better balance in Europe, which would include the whole value chain from API to finished medicines. This would ultimately help address concerns about security of supply.

This can be further supported by adopting European guidelines that ensure the Most Economically Advantageous Tender (MEAT) criteria for medicine tenders is respected in national procurement practices. This is a practice that ensures criteria other than price are taken into account in the tender process, such as accessibility, social or environmental characteristics, focusing on value rather than cost.  It can also be supported by improving our regulatory regime, notably by using the power of digitalisation to ensure fast transfer of information between regulatory authorities and industry, and monitor, mitigate and prevent shortages.  

In sum it’s about improving Europe‘s global position so we are not taken by surprise by any potential incidents, viewing pricing and tenders through the lens of security of supply, and using the power of digital processes to increase efficiency.               

Let me be clear, no one country or region can supply all of its medical needs and global supply chains are a strength not a weakness but but they should be diverse, balanced and sustainable. How can we find the best way to meet patients’ needs together, while taking all aspects of production into consideration? This is something of concern to us as players in the pharmaceutical industry, and it’s a fantastic opportunity to shape the future.

 * (Certificate of Suitability of Monographs of the European Pharmacopoeia; proof of active pharmaceutical ingredients quality, used for drug approvals )