< PreviousSECURITY 20 Pharma Business International www.pbiforum.net 20-23.qxp_Layout 1 08/04/2020 11:16 Page 1Pharma Business International 21 www.pbiforum.net SECURITY W ith the outbreak of COVID- 19, there were – and remain – many real and justified fears over the supply of crucial medicines, medical devices and healthcare equipment. Thus far there has been some disruption and delays and the ongoing pandemic continues to expose weaknesses in the global pharmaceutical system and supply chain insecurity – especially where prescription drugs are concerned. However, major pharma companies such as insulin maker Novo Nordisk say they do not expect supply shortages. No doubt a comfort for the 100 million people worldwide who depend on insulin injections, though the drug-maker has said that pharmacies could temporarily run out of medicines amid demand spikes. There’s no denying the impact the pandemic has already had on production, supply and distribution. China, the original source of the outbreak – and, for months, the epicentre – experienced a dip in drug production. As the nation brought its domestic outbreak under control, factories are now getting back to work. India, another major drug supplier, has announced that it will keep some of the medications it makes on reserve in anticipation of supply shortages. In the US, the Food and Drug Administration (FDA) has announced one drug shortage caused by the coronavirus but, tellingly, it would not disclose either what the drug is or where it is made, leading to rampant speculation. Supply issues are, understandably, impacting deliveries both to pharmacies and to vulnerable people by medicine delivery companies. These companies already supplied medicines and repeat prescriptions to individuals who cannot 22 Á Securing the supply chain Pharma Business International explores how coronavirus is disrupting medicine supply, and the safety and security measures being utilised in delivery. 20-23.qxp_Layout 1 08/04/2020 11:16 Page 2SECURITY 22 Pharma Business International www.pbiforum.net easily leave their homes to access a pharmacy – or for those who cannot drive and live too far from a pharmacy. Since social distancing measures were made law and lockdown measures have been introduced, there has been a greater demand on these delivery providers to serve those individuals self- isolating who have underlying health conditions that still require medicines. In order to cope with demand and ensure safety and security for all parties, technology has been utilised. Apps loaded onto drivers’ smartphones can provide information about their delivery routes, highlighting those people that are self-isolating and where to leave medicines to safely avoid contact with that person. Drivers, in general, are having to change the way in which they approach deliveries amid the crisis – for example, instead of having a person sign for their medicine or goods to prove it has been securely delivered, they’re instead taking pictures of the delivered goods by the door (or in the safe place), thus minimising the need for people to interact and reducing the risk of infection. Although there’s been an increase in demand for those logistics and distribution service providers that already serve patients, pharmacies and healthcare providers, logistics companies across the board are taking on new contracts such as suppling PPE (read more about PPE on page 32) to the NHS, for example, and helping to deliver medicines. With its growing healthcare division and its monopoly over the ecommerce marketplace, it’s no surprise that amazon is getting involved. Government agency, Public Health England, has announced that millions of fifteen-minute home coronavirus tests will be made available on the high street or for delivery via Amazon to people self-isolating. Of course, the question arises over the safety of receiving any kind of delivery – medicine or otherwise – which could potentially be contaminated by coronavirus. According to a study published in the New England Journal of Medicine, the virus that caused Pharma Business International 23 www.pbiforum.net SECURITY COVID-19 remains for several hours to days on surfaces an in aerosols. However, the World Health Organisation (WHO) has said that “the likelihood of an infected person contaminating commercial goods is low”. The WHO added that “the risk of catching the virus that causes COVID-19 from a package that has been moved, travelled, and exposed to different conditions and temperature is also low”. As demonstrated by the increase in distribution and safety measures involved, ensuring supply chain security is crucial to responding to and mitigating disruptions and combatting the spread of COVID-19. © Shutterstock /noppawan09 © Shutterstock /felipe caparrosMANUFACTURING 24 Pharma Business International www.pbiforum.net Manufacturing a solution 24-27.qxp_Layout 1 08/04/2020 11:18 Page 1Pharma Business International 25 www.pbiforum.net MANUFACTURING © Shutterstock /Dmitry Kalinovsky P harmaceutical manufacturing remains one of the most automated and refined of industries in the world, more be necessity than anything else. With stringent hygiene requirements, the human element has been removed from the production line at key points, and this has led to efficiency that other industries have been slow to pick up. Even the food and drink industry, which runs similar hygiene and sanitation protocols as pharmaceutical, still boasts human involvement in manufacturing, with the UK in particular falling behind European and global rivals to embrace robots and automated production lines. Costs in investment and keeping up with this production have made maintaining lines difficult, however. There is always new technology, and with old machines becoming outdates or inefficient by comparison, there is often a need to push further, lest the competition do so in your place. Contract manufacturing has become a popular alternative as a result, essentially allowing pharma giants to outsource their manufacturing needs. Outsourcing production used to be a risky prospect, something that was only considered as a last-minute resource in a situation where an influx of demand, or a problem with your own production line had taken place. Nowadays however, with the increased technological development – and as a result the more affordable access to technology – outsourcing pharma production is not as risky a prospect as it once was. Keeping up with changes in manufacturing can be difficult, which is why so many outsource such concerns to others. 27 Á26 Pharma Business International www.pbiforum.net © Shutterstock /Panatda SaengowPharma Business International 27 MANUFACTURING In fact, it’s now a booming industry. Mostly handled by CMOs (Contract Manufacturing Organisations), the healthcare CMO market is booming rapidly, and is anticipated to show a CAGR of 14.3 per cent leading up to 2019. This has led to many major pharmaceutical firms making the choice to utilise CMOs for one hundred per cent of their production capabilities, greatly reducing staff costs and other overheads. When it comes to the CMO industry, major plays are the US and Europe, who have a large number of healthcare CMOs within their territory. Germany, Italy and the UK are particularly active in the EU – with Germany having a clear lead in terms of the sheer number of CMOs that specialise in the pharmaceutical industry. This is expected to be a compound factor of pharma giants making increased use of CMOs. But the figure is also strengthened by the ending of a number of patents which will likely see a flurry of suppliers seeking to provide now un-patented drugs at much lower rates. The advantages of contract manufacturing, or outsourcing in general, extend beyond the variable costs of manufacturing and into overheads in staff, maintenance and even property. No manufacturing means no factory, saving space and rental costs. Of course, becoming fully reliant on outsourced manufacturing comes with its own issues, namely that of flexibility and dependency, but so long as a company does not put all their eggs in one basket, this risk is mitigated. With how fast the manufacturing industry moves, it is tempting to place the burden of keeping up on another. While it will never be as profitable in simple terms to outsource – the contract manufacturer has to make a profit somewhere, after all – pharma companies can invest the money they would have spent on capital, investment and maintaining a facility, into R&D instead, investing in the creation of new drugs that might keep them more profitable in the future. As such, while the approach is not inherently as profitable in itself, it can be more sustainable in the long run. 24-27.qxp_Layout 1 08/04/2020 11:18 Page 4© Shutterstock /JPC-PRODDIGITAL INNOVATIONS Pharma Business International 29 www.pbiforum.net I n the wake of COVID-19, technology is being well utilised to keep people safe. Digital health solutions are set to revolutionise how people across the globe gain higher standards of health and secure better access to health services. As increasing strain is placed on the healthcare sector, various technologies have been thrust centre stage to alleviate some of this pressure, with digital tools monitoring the spread of Coronavirus and facilitating improved treatment. China for instance moved half of its medical care online in response to the outbreak and GPs across the world have been asked to carry out remote appointments to minimise transmission risk, sending out texts to patients to ward them off going to surgeries. The model of patient interaction has changed in the face of Coronavirus. Demand for telehealth has spiked as the reach of healthcare professionals needs to be extended, and digital doctor platforms have seen a significant acceleration in consultations. Health tech suppliers are developing new products to assist health services, to make certain doctors have the tools required to support people in self- isolation or with symptoms, or indeed those with different cases who still need attention at this time, or perhaps need to order prescriptions. Video consultation platforms have been key in the COVID-19 outbreak, in reducing the number of patients visiting surgeries and managing those who potentially have Coronavirus, enabling them to be monitored remotely. With video, the public can gain safe access to medical professionals via apps on phones and computers, meanwhile healthcare staff remain protected, and in cases where they themselves may need to isolate, they can still provide care. Various screening and information tools have also been developed to help members of the public assess their symptoms and risk factors, allowing them to answer a few questions to be directed on the next steps they should take, to relieve the burden on the health sector. Wearables are also growing in importance, being utilised to catch possible cases of Coronavirus and other diseases early. Scripps Research Translational Institute has launched the app-based Digital Engagement & Tracking for Early Control & Treatment study (DETECT), wherein devices such as Fitbits and Apple Watches, which capture real-time data, are being used to track heart rate, sleep and activity levels, alongside participant submitted symptom reports, to alert abnormalities before COVID-19 symptoms and fever occur. At the end of March, The digital response to COVID-19 30 Á The COVID-19 pandemic has forced the historically hesitant healthcare industry to become more digital. 28-31.qxp_Layout 1 08/04/2020 11:19 Page 2Next >