Pharmaceutical Market Europe • September 2022 • 38-39
PHARMA'S UKRAINE CRISIS RESPONSE
How pharma can build on past experiences and the innovative processes developed during the COVID-19 pandemic to mitigate the devastating effects of war on patients
By Thomas Dobmeyer
After months of war, life for patients in Ukraine continues to get harder. The World Health Organization (WHO) has reported that people’s health has been imperilled by difficulty in accessing emergency care and essential medicines.
Hans Henri Kluge, WHO regional director for Europe, noted that there had been more than 260 verified attacks on healthcare facilities in Ukraine by early June, resulting in some being destroyed and others struggling to cope with people who are seeking care for trauma and injuries.
The war has also made it extremely difficult for patients with chronic conditions, such as diabetes, to access the medicines they require. While pharmaceutical companies remain committed to ensuring patients everywhere receive life-saving medications, some have suspended operations in Russia for non-essential medications, which has the potential to further exacerbate supply chain bottlenecks.
Manufacturing and the supply of finished medicines, as well as raw materials in the region, has also been severely affected. Many insurance companies have implemented tougher requirements to cover Ukraine supply contracts, which has restricted cooperation with international suppliers. Fortunately, local manufacturers been able to use their expertise to step in and negotiate new terms to ensure the supply of active pharmaceutical ingredients, excipients, packaging materials and other raw materials. However, managing the supply routes of medicines and raw materials in Ukraine has been challenging due to ongoing attacks and the closure of airports and seaports. In response, suppliers have had to respond quickly and make adjustments to routes.
The war has stopped many clinical trials in the region, with GlobalData’s Clinical Trials Database saying that by April 2022, eight phase 2 and phase 3 trials had been disrupted and another eight trials were in jeopardy as sponsors were forced to suspend enrolment in Russia and Ukraine. The impact is likely to be more extensive, with the US Food and Drug Administration noting that around 250 drugs and devices were undergoing clinical trials in Ukraine. Trials in Russia have also been impacted, with Moscow State Medical University noting that international pharmaceutical companies have halted recruitment of new patients to its 120 ongoing trials.
There are steps that sponsors and clinical research organisations can take to ease the crisis with clinical trials and, wherever possible, ensure patients keep participating. A priority should be to ensure ongoing follow-up with patients and doctors involved in the trial, do what they can to track where patients are located and, where possible, enable them to continue to participate in other parts of the world.
Clinical trial data should also be accessible via online channels, from when treatment starts to when it is completed, while also doing whatever is needed to prevent unblinding of participants. To achieve that objective, companies should put in place processes to safeguard that data, such as implementing data provenance, data privacy, traceability and auditability. Another important step will be to provide emergency contact details to patients who have been displaced by the war so they can get the care they need.
Experiences from previous wars do offer examples of mitigation steps that can help to ensure patients get the care they need. However, the most valuable lessons may be from the COVID-19 pandemic, which required companies to quickly pivot in order to ensure business continuity. In particular, technology and digital enablement came to the fore during the pandemic. Clinical trials increasingly became decentralised and healthcare providers turned to telehealth or digital health to connect with patients.
These innovative processes are now being used to provide virtual care to patients in need. As an example, the non-profit organisation Health Tech Without Borders (HTWB) was founded in 2022 in response to the war in Ukraine and acts as a hub to connect digital innovation with medical care. HTWB’s Ukraine Telehealth Relief aims to help hospitals cope with the rapid increase in patients, provide psychological help to those affected by the conflict and support Ukrainian refugees across Europe.
As providers and consultants in the healthcare industry, we are committed to using our expertise to help pharmaceutical clients, for example through the establishment of a network, or advisory alliance, across the industry, non-government organisations and healthcare providers to identify unmet needs, urgent priorities and solutions and recommendations to support patients in impacted regions.
For all of us in healthcare and the life sciences, mitigating the suffering of patients has to remain our primary concern.
Thomas Dobmeyer is CEO of PharmaLex
How pharma has responded to the urgent medical needs resulting from the conflict in Ukraine
By Emily Kimber
The World Health Organization (WHO) has published an interim report on its response to the Ukraine crisis, detailing the ‘unprecedented’ mobilisation and crisis response between February and June 2022 by WHO and the organisation’s partners.
The conflict has increased the need for healthcare while reducing the system’s ability to provide services, particularly in areas of active conflict.
With a clear focus on ‘sustaining life-saving services, no matter what’, WHO and its partners have sought to respond to urgent medical requests as a direct consequence of the conflict, while also maintaining the continuity of care for life-threatening and chronic conditions.
In response to the need for continued access to treatment, pharma companies have offered aid through direct financial support, as well as the supply of life-saving medicines. The Association of the British Pharmaceutical Industry (ABPI) has detailed the response of its member companies offering humanitarian support both in Ukraine and for the emerging refugee crisis in neighbouring countries.
In Sanofi’s May update on its response to the Ukraine crisis, the company announced that its philanthropy arm, ‘Foundation S – The Sanofi Collective’, had made over €21m worth of essential medicine and vaccine donations to the Red Cross. This included 30 million daily treatments for diabetes, cardiovascular disease, epilepsy and other life-threatening and chronic conditions. The company has also donated over 300,000 diphtheria and tetanus vaccines.
According to the International Diabetes Federation, there are over 2.3 million people with diabetes in the Ukraine, making up 7.1% of the population. Eli Lilly’s supply of medicines, including over two million doses of diabetes and cancer products have made their way to hospitals and patients in Ukraine via the company’s humanitarian partners. Its most significant supply of medicines includes insulin, with more than 117,000 vials and pens delivered to humanitarian aid organisations Direct Relief and Project HOPE. The company also said in an update that it had sent a supply of its COVID-19 therapies to Ukraine, along with two additional supplies of diabetes and cancer products to Direct Relief.
Pharma has also been responding to the need for HIV treatment. Ukraine has the second-highest number of HIV cases in Eastern Europe and Central Asia, according to Joint United Nations Programme on HIV/AIDS (UNAIDS). To meet the needs of this population, through ViiV Healthcare, GSK has been making significant donations of antiretroviral medicines available to WHO, national AIDS programmes and NGO partners to support children and adults living with HIV who have been impacted by the conflict. Gilead Sciences has also been working to address the needs of Ukrainian refugees with HIV.
The continued access to oncology treatments has also been an area of focus in order to avoid life-threatening disruptions to patients’ cancer care. Ukraine has a high cancer burden, with more than 160,000 new diagnoses in 2020 alone. Pharma companies have been delivering oncology treatments in an effort to meet this need. Novartis, for example, announced in June that it had delivered over $33m worth of medical aid, which included oncology treatments, as well as antibiotics, painkillers and cardiovascular treatments. In its initial statement, Pfizer also announced that it would donate medicines and vaccines from both its existing supply in Ukraine and from the US, including nearly 700,000 doses of oncology medicines, antibiotics and antifibrinolytics.
As well as maintaining the continuity of care, pharma has also responded to urgent medical requests caused by the conflict. With the help of WHO, Roche has shipped packs of antibiotics and batches of anaemia treatment to Poland and Ukraine. The company has also responded to the increased need for blood and blood products, sending thousands of reagents and consumables for automatic testing of blood samples to the Ukrainian Ministry of Health, which were distributed to 17 sites across the country to ensure patients do not receive contaminated transfusions.
Some companies have also taken a different approach to support Ukraine. Honouring the biopharma sector’s historical exemption from economic sanctions and an obligation to deliver life-saving medicines, regardless of circumstances, Pfizer announced that it would donate the equivalent of all profits from Russian sales to causes that provide direct humanitarian support to Ukraine, with the company announcing in June that it would ‘make good’ on this promise, with AbbVie announcing its intentions in April.
Emily Kimber is an assistant journalist at PMGroup Worldwide Ltd