Business continuity of healthcare companies is being significantly challenged and there are serious risks of supply chain disruption due to the global Covid-19 emergency. It is critical that companies assess, manage and control these risks to ensure continuity of supply.
HiTech Health has extensive experience and expertise to support our clients with:
- Business continuity assessments and processes for Pharmaceutical and Biopharmaceutical companies.
- Assessing current supply chains and helping to implement controls to ensure there is continuity of clinical and commercial supply.
- Mitigation strategies for short, medium and long-term risks.
COVID-19, which is caused by the coronavirus, has had a major global impact since its outbreak in China in December 2019. Immediate concerns are for the well-being of employees globally and a focus on business continuity planning.
The European Medicines Agency (EMA) have recently issued new guidelines surrounding the development of therapeutics and vaccines to treat COVID-19 (1). These measures are centred around preventing and mitigating supply issues of medicines used to treat COVID-19 patients. Whilst respecting regulatory requirements, the COVID-19 EMA Pandemic Task Force enables fast regulatory action on development, authorisation and safety monitoring of treatments and vaccines for COVID-19. EU regulators have implemented greater flexibility regarding submission deadlines, briefing information and dossiers and review times on applications have been reduced from up to 70 days down to 20 days. In addition, rolling reviews of data have been implemented for COVID-19 treatments in development. Marketing Authorisation (MA) applications for COVID-19 have also been granted expedited review.
The rapid spread of the virus has already had significant impact on global supply chains, including pharmaceutical, biotechnology and medical device organisations that have complex supply chains spanning multiple countries. For the last few months, much of the world’s population has been living and working in lockdown. Some countries such as France, UK and Ireland remain under some form of restrictions, while countries like Italy, Spain and the Asia Pacific countries have begun re-opening their economies in co-ordinated phased plans. Many companies have critical suppliers located within the lockdown regions and thus, the re-opening of these regions may hopefully reduce any disruptions on the manufacturing, supply and delivery of key medicinal products to patients.
The EU Executive Steering Group on Shortages of Medicines Caused by Major Events in response to the pandemic outbreak continues to investigate measures to relax regulations I order to ensure as little disruption as possible to Supply Chains globally. The EMA have also requested patients only receive their typical supply of medicines to prevent strain on drug supply chains. Globally regulators are working together to align policy approaches and regulatory flexibility during COVID-19 pandemic.
The FDA continues to release updated guidelines related to expedited approval of COVID-19 necessary treatments, mostly in relation to medical devices. In addition, actions to accelerate the development of novel preparations and treatment options for COVID-19 include more efficient submission and processing of applications to FDA and clear and concise recommendations on clinical trials (2).
Global air cargo revenues have increased in April 2020 by 36% in comparison to April 2019, despite the volume of air freight having decline by 32%. Global air freight capacity has decreased by 25% in comparison to the same month of the previous year. As a result, securing freight capacity has become challenging and increasingly costly, sometimes up to 5-times the price of the same freight rates only three months ago. It is critical to ensure your company has assessed your supply chain, forecasted your inventory supply and booked air capacity at least two weeks in advance of shipping. HiTech Health can work with you to identify, assess and mitigate the risks posed by the current global health crisis to your shipping lanes. Ultimately, our goal is to ensure that patients who rely on medicinal products continue to be supplied in an efficient and steady way.
Quality and Regulatory
The EU Commission, EMA and the European medicines regulatory network announced the development of a Q&A document providing guidance to key stakeholders on the current changes to the regulatory network during the COVID-19 pandemic. The document has a particular focus on medicines used to treat patients with COVID-19, in an attempt to address any potential drug shortage that may occur.
The guidance document covers many areas including market authorisation, manufacturing and importation of API and finished product and labelling requirements, in an attempt to address the regulatory flexibilities that can be used to facilitate pharmaceutical companies in bringing their products to market (3). Where possible, seek the advice of regulatory experts in order to help navigate your way through these updated guidelines.
Similarly, the Irish regulator, the HPRA, have announced that due to the extenuating circumstances, QP batch certification of medicinal product may take place remotely (i.e. at a site other than that registered on a company’s Manufacturing/Importation Authorisation) pending HPRA approval. HiTech Health has a team of Qualified Persons (QPs) who assist in obtaining HPRA approval for remote QP certification and who can perform batch certification thereby supporting you to continue to supply medicinal product to the clinical trial or marketplace.
Clinical Trials have also been affected worldwide. According to new EMA guidelines, new and on-going clinical trials should be risk assessed immediately to understand whether is feasible to initiate or continue clinical trials in this current climate (4). HiTech Health can assist you on risk assessment and mitigation’s plans so that your patients’ safety and the integrity of your clinical trial are not compromised.
Key Considerations for your company
Companies that source, manufacture or supply medicinal products that are currently not deemed essential COVID-19 treatment should consider the following:
- Have you assessed your supply chain for the short, medium- and long-term future? Is it time for you to move from a single source supply chain to dual sourcing model?
- If using contract organisations for the manufacture of your product, have you secured capacity for the next 2-3 years?
- Are all the materials for the manufacture of your product available for the remainder of 2020 and through to 2021?
- Expect potential cancellation or delays of shipments. How will you ensure your product remains safe and within the required storage conditions?
- Ensure sufficient inventory levels to avoid disruption to on-going clinical trials or commercial supply to patients in need. How will COVID-19 affect your forecasting and production scheduling for the rest of 2020 and years to come?
- The financial impact of increasing costs of manufacturing and supply costs in addition to the stock market decline. Has your organisation developed financial risk mitigation plans?
- Assess the impact that employees and partners working remotely will have. How will this affect your IT infrastructure, HR requirements and support for manufacturing and supplying products in a timely manner?
- Assessed short, medium- and long-term operational restrictions for the movement of goods?
- Redesigning shipment sizes due to availability of capacity in your shipping lanes?
- Assessed the impact of lockdown regions on shipping qualification/validation studies?
This list above is not exhaustive, however, it provides examples of some key consideration to be reflected upon to avoid serious disruption. What is critical is that Companies plan and manage through such times of uncertainty in order to provide the best possible outcomes for their business.
Contact HiTech Health here for more information.