WTO Identifies Bottlenecks to COVID Products Ahead of Key Meeting with WHO COVID-19 20/07/2021 • Editorial team Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) The World Trade Organization (WTO) Secretariat has issued a list of bottlenecks and trade-facilitating measures on critical COVID-19 products, ahead of Wednesday’s High-Level Dialogue between itself and the World Health Organization (WHO) on how to expand COVID-19 vaccines manufacturing to ensure equitable access. “One common theme that emerges from the list is that essential goods and inputs need to flow efficiently and expeditiously to support the rapid scaling up of COVID-19 production capacity worldwide,” according to the WTO. “The delay of a single component may significantly slow down, or even halt, vaccine production given the globally integrated supply chains that underpin COVID-19 vaccine manufacturing.” The list is based on issues raised at two WTO meetings last month, ‘Regulatory Cooperation during the COVID-19 Pandemic’ (2 June) and ‘COVID-19 Vaccine Supply Chain and Regulatory Transparency’ (29 June). Below is a summary of the key points: BOTTLENECKS Vaccine manufacturing There are no expedited procedures for vaccines, which are subject to standard import and export procedures, including rigorous documentation and frequent renewal of licences and certificates. Vaccine manufacturers may find it difficult to send non-commercial samples to specialized laboratories located abroad for testing, as these samples are subject to the same import and export procedures as commercial shipments. Exports by vaccine manufacturers to foreign ‘fill and finish’ sites can be subject to export restrictions, both for sites owned by the manufacturer and the contract development and manufacturing organisations (CDMOs). Donations of supplies and vaccines (eg to COVAX) can be subject to stringent controls as well as tariffs and internal taxes. Some embassies and consulates are closed as a result of lockdowns, making it impossible to complete consular transactions or to submit documents needed for cross-border trade of vaccine inputs. Tariffs are high for certain inputs in some manufacturing countries. Complicated visa entry requirements and closed borders make it hard for highly qualified personnel to move across borders to support vaccine manufacturing. Vaccine regulatory approval Differences between countries in terms of regulatory frameworks, procedures and timelines adds complexity for manufacturers. Significant variation among registration requirements across different regions can make it onerous for manufacturers to apply for registration in multiple locations. Some national regulatory authorities (NRAs) require local retesting of vaccines or bridging clinical trials, which can lead to delays and spoilage. The rapid development of COVID-19 vaccines has led to additional challenges and burdens for vaccine manufacturers following the initial emergency use authorization (EUA), such as gathering data and optimizing processes. Some NRAs have not established accelerated pathways for post-approval changes to vaccines under EUA, which could hinder availability due to delays in approval. There can be uncertainty about when EUA will expire and the accompanying processes to move to regular approval and registration of vaccines (including against new coronavirus variants). A particular concern is that rules and accompanying data and legal requirements will differ between regulatory agencies. Vaccine distribution While few obstacles were identified for the distribution and border clearance of COVID-19 vaccines, border clearances for related products to administer vaccines (eg syringes, refrigerators) was flagged as a potential problem. Therapeutics and pharmaceuticals There can be different technical requirements for the same product between countries (e.g. 3.5 ml versus 3.51 ml, different sterilization requirements). This requires vaccine manufacturers to establish separate production lines, which increases costs and compromises speed of delivery. NRAs request different process changes to approved products in an uncoordinated manner, which requires manufacturers to carry multiple manufacturing processes. Some NRAs require local population-based studies for medicines with no evidence of ethnic pharmacokinetic differences Applied tariffs are high in many countries, making it costly to import essential therapeutics to treat COVID-19 patients. Diagnostics and other medical devices Divergent regulations and barriers to accessing viral samples that are needed to develop effective diagnostic tests. Some NRAs may still require a consularized apostille of the original paper document to confirm information already provided to the NRA and available online. Duplication of rigorous local testing can lead to delays and uncertainty for suppliers. An unclear process for regulatory approval of diagnostics can lead to diagnostics of varying quality. Inefficient and overly complex regulatory systems slow down activation of clinical trials and hamper the adoption of results. TRADE-FACILITATING MEASURES General import, export and transit procedures Implementation of the provisions in the Trade Facilitation Agreement (TFA), such as those concerning pre-arrival procedures, could help to expedite the movement of essential products to combat COVID-19. The digitalization and simplification of import, export and transit procedures (e.g. paperless trade) should be accelerated. Identification of Harmonized System (HS) codes for medical goods essential for the treatment of COVID-19 by the World Customs Organization (WCO) and the WHO helps to ensure expedited procedures for border clearance. Vaccine manufacturing Bilateral and regional agreements could ease import and export restrictions on key routes. A communication channel between vaccine manufacturers and other relevant stakeholders can raise awareness about bottlenecks at domestic and regional levels A national dialogue with manufacturers and other relevant stakeholders could be established to understand the current conditions for trade in critical vaccine inputs. Vaccine regulatory approval Measures can include the facilitation of Emergency Use Authorization (EUA) based on the prequalification procedure of the WHO EUL and regional networks WHO special procedures can be used to share regulatory dossiers under confidentiality agreements and to promote the use of reliance to allow low and middle-income countries to authorize emergency use of vaccines quickly and efficiently. Authorization of COVID-19 vaccines could be fast tracked. Rapid approval of clinical trials (phases undertaken in parallel in real time) could expedite approval of vaccines. The pharmaceutical industry could improve transparency and data integrity by providing better access to clinical data for all new medicines and vaccines Sharing data between regulators can facilitate multi-country approvals. Regulatory systems in developing countries can be strengthened for scaling up the local manufacture of vaccines. Therapeutics and pharmaceuticals Global harmonization with guidelines set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use would allow pharmaceuticals to be developed faster and to move more quickly between countries by overcoming conflicting or varying pharmacopeia requirements. Diagnostics and medical devices The Medical Device Single Audit Program of the International Medical Device Regulators Forum (IMDRF) could be used to overcome barriers to on-site inspection during a pandemic. The IMDRF could establish guidance for the regulatory flexibility needed during a pandemic. The WHO provides recommendations in Global Model Regulatory Frameworks and Regulatory Reliance for Medical Devices. • NRAs could implement a good regulatory practice (GRP) policy and related standard operating procedures. WHO guidance on recognition and reliance for pre- and post-market activities could be implemented. National standards and conformity assessment procedures (based on international standards) could be developed for local manufacturing of PPE. The streamlining of existing EUA pathways in the context of pandemics could result in diagnostics being registered and made accessible with less delay. Multiple-source supply chains can ensure that trade flows as freely as possible and with minimal export restrictions. A delay in the shipment of a single component could halt the entire production in a factory. General regulatory aspects Mutual recognition agreements could be promoted, as well as the recognition of marketing authorization procedures and the unilateral recognition of marketing authorizations. Inspection Co-operation Scheme could help to avoid duplication, and inspections could be further harmonized through enhanced cooperation between regulators. Global alignment of clinical trial requirements can increase the pace at which vaccines, therapeutics and diagnostics can be developed. Timelines for the evaluation and approval of medical products and clinical trials could be shortened if approval has already been granted by trusted regulatory authorities. • Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.