Editorial | Open Access | Published ?
GUEST EDITORIAL - Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders
There has been comment in the press about the possibility of medical supplies being delivered via drones. With the COVID-19 pandemic currently causing queues at Pharmacies and an increase in the need to get supplies speedily to the point of use, is this a time to seriously consider whether the use of drones would be appropriate and meet the requirements of Good Distribution Practice (GDP) required by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK in all or specific parts of the supply chain.
Within the US, drone deliveries of Pharmaceuticals have become a reality with AmerisourceBergen signing a deal with UPS in 2019 to deliver drugs to hospitals and distribution hubs whilst the deal with CVS Pharmacy will allow delivery direct to patients. Although both deals were announced in the press it is unclear the range of products that will be despatched using drone. Will those products requiring specialist storage conditions, and those that require special licensing e.g. controlled drugs be out of scope? Is this likely to be the new way in which the distribution of medical supplies such as urgently needed pharmaceutical products, organs for transplant blood etc occur?
The UK government has announced that drones will be used to carry medical supplies from Hampshire to the Isle of Wight, due in part to the delays being experienced by the significant reduction in frequency of ferry services to the Island during the COVID-19 Pandemic (https://dronelife.com/2020/04/30/medical-delivery-drones-uk/). The proposed trial will use a drone capable of carrying up to 10kg for up to 621 miles and will initially provide supplies for the one Hospital Trust on the island.
The legislation regarding Pharmaceuticals is not the only legislation to be considered when discussing the use of such drones to deliver pharmaceuticals, the Civil Aviation Authority must also approve the route. Currently the Regulation that legislates drones is an EU regulation with the requirement that a small drone remote pilot must only fly the aircraft if reasonably satisfied that the flight can safely be made. For longer journeys will a requirement for a Flight Plan to be filed be made? In addition, SUA operators and remote pilots that collect personal data must comply with the Data Protection Act 2018 (DPA), unless a relevant exemption applies. To deliver a medicinal product directly to a patient then exemptions to GDPR (General Data Protection Regulations) will need to be made. The Air Navigation Amendment (2018) and a consultation on the use of drones ‘Taking Flight the future of Drones in the UK’, was concluded on the 17th September 2018 both are available for review on the government website. Any company using a drone for commercial purposes must receive permission from the Civil Aviation Authority. However, both the consultation and the amendment do not consider the impact of the use of drones on other industries. As such is the use of a drone compatible with the current legislation regarding the distribution of medicinal products.
The Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (Text with EEA relevance) (2013/C 343/01) states the following:
Where transportation is performed by a third party, the contract in place should encompass the requirements of Chapter 7. Transportation providers should be made aware by the wholesale distributor of the relevant transport conditions applicable to the consignment. Where the transportation route includes unloading and reloading or transit storage at a transportation hub, particular attention should be paid to temperature monitoring, cleanliness, and the security of any intermediate storage facilities.
As such the drone providers must ship in a manner to ensure that the product temperature is maintained throughout the shipment. The current requirement to hold a Wholesale Dealers Authorisation if cold chain products are held or if 15- 25°C , store below 30°C and ambient products are held for more than 72 hours may mean that drone providers do not want to transport these products in case delays in flights means that they have to hold the products. Delivery to hospitals and pharmacies will allow the downloading and verification of temperature data to ensure that the product is transported at the correct temperature, however, if delivered direct to patients this will be problematic. Returns of products would also need to be carefully reviewed and the current legislation updated to ensure that it reflected the new supply chain scenarios that may be used. Verification of the supply chain for controlled drugs and licensing by the Home Office may also be barriers to the entry of drones into the standard pharmaceutical supply chain. For new and innovative treatments such as ATMPs would the risk of a temperature excursion and the consequence of such an occurrence mean that the risk of using a drone outweighs any benefit
There are certainly advantages to innovations in the supply chain and the potential benefits that the use of drones could bring to the the pharmaceutical supply chain from the pharmaceutical industry itself through to pharmacies, hospitals, clinics and patients. There will also be impacts on the drone designers and operators as they move into this new field of operation. Any changes would require legislative changes to both the drone legislation and the pharmaceutical GDP legislation, whilst ensuring that there are sufficient controls regarding bona fides and storage temperatures of medicinal products within the supply chain are maintained. Currently although used in the US and other countries there are barriers that need to be overcome to allow this technology to be used on a routine basis within the UK. Pharmaceutical manufacturers and wholesale dealers need to explore the risks versus the benefits of using drones in their supply chains to determine if they are suitable for their products under routine or exceptional circumstances. If the answer to either or both is yes, then there will be a need to lobby governments directly or via trade organisations etc for urgent consideration of change to legislation.
The Pharma industry needs to innovate and keep up with technological opportunities within its supply chains as well as within manufacturing. The potential to use drones as an unmanned courier service with the potential to be used for delivery direct to patient or point of need, particularly in remote areas around the world could and perhaps should be taken up by both the pharma supply chain and regulatory bodies around the world
Pam Turner
Director and QP at PNR Pharma Services Ltd.
(PHSS Management Committee member)