Current Issues

The supply of medicines, medical devices, and other healthcare products such as PPE was placed under immense strain during the first wave of the COVID-19 pandemic. This was particularly the case during March and April 2020, when the volume of medicines passing through the supply chain rose substantially. The existing system was stressed to the extreme, with demand in both primary and secondary care increasing considerably. Many prescriptions in primary care were written for three months instead of 28 days, and critical care medicines experienced a significant uplift in demand...

In the run up to the end of the Transition Period on 31st December 2020, the HDA worked closely with the Department for Health and Social Care and other medicines supply chain representatives on assessing levels of preparedness to ensure the continued supply of medicines across the four countries of the United Kingdom. With the Transition Period having come to an end, the UK is now a third country in relation to the EU. The HDA welcomed the Brexit deal agreed to in December 2020, stressing that this was the...

The Falsified Medicines Directive (FMD) is a European Union regulation designed to protect Member States from the threat of falsified medicines. It requires individual medicines to be verified throughout the legitimate supply chain, protecting patients from potentially dangerous, illegal drugs, with individual packs of medicines being allocated unique 2D matrix codes that can be scanned to give details of authenticity. It came into force in UK national law in August 2013, with the associated Delegated Regulation of the Directive coming into force in February 2016. The HDA was fully engaged...

Following the PIP breast implant scandal in 2010, the European Commission signalled in September 2012 its intention to increase the regulation of medical devices in the EU to increase consumer and clinician confidence in the safety of medical devices. Measures included strengthening the supervision of the notified bodies that carry out the pre-market assessment of medical devices, expanding and increasing the transparency of the European database on medical devices, and the requirement for medical devices to carry a unique device identifier (UDI). The HDA worked closely with the European Healthcare...

The HDA intends to show leadership as a sector in reducing the carbon emissions of the medicines supply chain, both to minimise the impact of the sector on the environment and to meet the future targets required of NHS suppliers. The HDA has created a Net Zero Working Group, which coordinates the association's efforts. We are furthermore a participant in the NHS Sustainable Supplier Forum, collaborating with the NHS on their sustainability agenda. This agenda requires collaboration between the entire medicines supply chain to succeed. The following constitutes the HDA’s...

HDA members have concerns around what they observe as inconsistencies and inequalities in the regulatory environments governing the end-to-end supply of medicines, specifically in relation to the transportation of ambient medicines and expected temperature controls. The journey of this type of ambient medicine from manufacturer to patient involves the product being moved through a supply chain with differing standards. Medicines originate with manufacturers (regulated by the MHRA under GMP) and transferred to wholesalers (regulated by the MHRA under GDP). They are stocked at retail, distance, and other types of pharmacies...

The healthcare distribution sector is changing rapidly. Pharmaceutical wholesalers no longer operate in isolation. Patients, pharmacies, hospitals, doctors and the pharmaceutical industry are more closely integrated than ever before. There are numerous factors driving this change. The globalisation of medicines supply All parts of the medicines supply chain are not just consolidating at the national level, as pharmaceutical companies and healthcare distributors are combining into larger groups internationally. This consolidation increases buying power, brings efficiencies and means medicines are increasingly traded globally. Yet, the current market is also experiencing extremely...

Aside from distributing to all community pharmacies and dispensing doctor practices across the UK, HDA member wholesalers also manage and distribute to all NHS hospitals. This is an area of increased focus at the moment. The HDA is working with the NHS and the Department of Health as part of the wider Carter initiative, which is examining how to make NHS secondary care procurement of medicines more efficient and contribute to overall NHS performance. The ongoing HDA/NHS meetings are considering opportunities/hurdles in hospital IT systems, procurement rules and e-commerce. The...