Dear President von der Leyen, Executive Vice President Dombrovskis, Commissioners McGuinness, Lenarčič and Kyriakides,
The pharmaceutical industry in Europe stands in solidarity with the people of Ukraine. We strongly condemn the invasion of their country and express our sorrow at the suffering it has caused. As an industry dedicated to saving and improving lives, we stand for peace. Over the coming days and weeks our priority will continue to be to ensure that patients in Ukraine, Russia, as well as refugees arriving in EU Member States and patients in other territories impacted by this war, have access to the medicines they need. Industry will also work hard to ensure that any potential impact of the current situation will not have a disruptive effect on access for patients in the rest of the EU.
Health-related associations are all working with their members to support the emerging humanitarian crisis as a result of the war. This includes in-kind donations of much needed medicines as well as financial support. We are liaising with our member companies and national associations to identify manufacturers of the medicines highlighted in the lists provided by the Ukrainian Ministry of Health and by your Colleagues in the HERA Task Force. And we are coordinating our response with humanitarian organisations to ultimately deliver this aid. As an example, EFPIA provides a detailed and continuously updated overview of our member’s efforts on our website here.
We continue to monitor and adapt our supply chains and clinical trial activities as they are being challenged by the ongoing war and would like to raise the following important points to your attention:
1. In order to ensure patients impacted by the conflict continue to receive the medicines they need, we must ensure that supply chains continue to operate. Truckloads of medicines are currently being held up at different points of the Ukrainian borders due to the conflict, transportation backlogs are starting to build up with a risk of a slowing down of regional production, some warehouses in Ukraine are closed or surrounded by hostilities, and vessels and trucks with medicines are unable to reach their destinations. One lesson learnt from COVID-19 lockdowns was that air cargo traffic was a crucial element to avoid land blockades. We would therefore like to ask all parties to allow passage and transit for medicines, treatments, vaccines and their ingredients so that supplies are not disrupted and can reach patients in need.
2. Clinical trials are a key means for patients in Ukraine, Russia and elsewhere to get access to innovative treatments and medicines. Because of the hostilities, we understand that clinical trials in Ukraine are facing increasingly difficult circumstances and that continuing them is also proving challenging in Russia. Some members have decided to put screening and recruitment of patients
on hold while trying to support enrolled patients in ongoing trials. It must be noted that because of the multi-regional nature of some the trials, there could be an impact on clinical trials in the EU in some instances if trials in Ukraine and/or Russia are halted.
3. Another lesson learned from COVID-19 allocation of medicines, is that patient-need data is key to ensure the right medicines reach the right patients at the right time. We recognise that the emerging refugee crisis in EU Member States neighbouring Ukraine is already creating significant demand on health services in those Member States. Understanding the demographics, locations, medicines- and vaccines-needs of refugees escaping the violence will be critical to help us plan and manage supply to ensure we can meet their needs. Exchanging any data to better understand this picture would be incredibly helpful as would be European Commission support to avoid measures like stockpiling from EU and non-EU Member States at a moment when maximum flexibility is needed to respond to changing demand patterns.
4. We also like to raise the challenge of significantly disrupted national routine immunisation programmes due to COVID-19. This means that individuals from infants to elderly both in welcoming EU Member States and among the refugees from Ukraine, can be at risk of vaccine preventable infections. It would be important to have a reliable picture of the vaccination uptake for most vaccine-preventable diseases in Member States, particularly those most affected by the refugee crisis.
5. While we fully respect and understand the sanctions as a tool in response to the invasion of Ukraine, from a humanitarian standpoint, as the providers of life-saving treatments and medicines to patients, we ask the EU to adopt clear and administrable humanitarian exceptions to sanctions for essential goods such as food and medicine, consistent with longstanding EU policy. More specifically, we ask for the exclusion of medicines, vaccines and their ingredients, as well as goods and services needed for the production and delivery of medicines and related items from the sanctions to help us in our humanitarian response. For this reason we also ask for support to allow clinical trials to continue, given that they are serving patients in dire need. We would appreciate if the European Commission and industry could work together to ensure that no unintended sanction-induced disruptions of pharmaceutical supply chains and clinical trials take place.
We want to help and support in any way we can to alleviate the situation for patients as a result of this war and look forward to engaging further with the European Commission as the situation continues to unfold.
Medicines for Europe