What COVID-19 means for generics companies

Generics companies have found themselves at the forefront of fighting COVID-19 – but it has required rapid change at all levels of the business. We spoke to Accord’s executive vice president EMENA, Dr James Burt, to get an on-the-ground view of how drug firms like his have had to adapt in these unpredictable times.

How has the COVID-19 pandemic affected generics companies like yourselves? 

Everyone has had to adapt, that much is clear – but more than adapt, we had to pre-empt how the situation would unfold, as far as we could.

We, and other manufacturers like us, have had to plan very carefully to ensure that our medicines continue to reach patients in a range of apocalyptic-like scenarios.

Take the UK for example; Accord currently supplies approximately one in five generic medicines to the NHS. That is a serious responsibility for us and security of supply is critical.

In early February, it was clear that we were about to experience a global pandemic. We had already developed our own forecasting model to predict which medicines would be in demand and when; which in turn has enabled us to ship active pharmaceutical ingredients (API) before export bans and, at the same time, step up our production to match the surge in requirements across the EU.

I recognise my bias here, but I have been completely bowled over by the dedication of our staff in the most challenging conditions continuing to manufacture and deliver supplies of vital medicines where they have been needed most. Production lines, batch sizes and delivery volumes have had to be rapidly changed to meet growing demand and ensure sufficient stocks of a range of medicines are available in the EU. We have likened it to war times within Accord; imagining future generations asking how we played our part in the efforts against COVID-19. I hope we are justified in saying that we are incredibly proud of our contribution.

How have you tried to ensure business continuity?

Continuity is king when it comes to medicine supply. Logistics turned out to be a key COVID-19 challenge. As passenger flights were cancelled it became immediately apparent that much of the world’s pharmaceutical supply is carried as ‘belly cargo’ in commercial flights and, overnight, available air cargo was reduced to almost zero. On top of this, with lockdown came extreme issues with border and customs controls.

We worked with a number of groups such as BGMA, Medicines for Europe and the Indian Pharmaceutical Association to lobby governments to introduce practical measures such as ‘green lane-ing’, classification of pharmaceutical staff as key workers exempted from quarantining and returning customs, logistics and other necessary staff to ensure the flow of medicines. We also worked hard with airlines and export companies to return access to freight.

Are there any specific drugs or initiatives you are focusing on at the moment?

Our scientific team scoured the medical literature looking for older medicines that could be repurposed. The anti-inflammatory, anti-malarial, hydroxychloroquine, was identified very early-on as a candidate for clinical research. We proactively shipped the active pharmaceutical ingredient from Asia before the export bans hit and within 22 days, we had successfully manufactured approved (within its existing MA) hydroxychloroquine here in the EU. We were proud to donate this initial supply of two million tablets to the world’s biggest interventional COVID-19 study, involving 40,000 frontline healthcare workers.

Last month the Department for Health and Social Care announced that the UK’s supplies of vital muscle relaxant medicines for patients using mechanical ventilators would be exhausted in just a few days. Given our focus on increasing our ICU medicines production, as soon as we understood the scale of the pandemic, we increased our supply in anticipation of this surge in demand.

It’s not just the lesser known medicines that the generics industry is relied on for – paracetamol has been in significantly greater demand during this pandemic. Anticipating this, we also increased production of paracetamol and have worked with governments and regulatory bodies to ensure patients have access to it when needed.

How can different stakeholders work together to tackle the crisis?

That’s the question that we were asking from the very beginning. No single company can – or should be trying to – provide the solution to this exceptional global emergency alone. Our industry is highly competitive, but there is simply no room for players trying to ‘out-do’ their competitors during this crisis.

We spent a lot of time lobbying for healthcare companies to work together as never before, to help identify and resolve gaps in essential medicines supply, in order to ensure the EU had access to vital COVID-19 medicines and to avoid over-ordering or stockpiling.

One great example was that we were approached by another pharmaceutical company that was looking to significantly expand its production to meet the surge demand from intensive care units. This company was able to make more of some vital pain relief products but didn’t have enough controlled drug storage space. We happen to operate the largest manufacturer-owned storage and distribution centre in the UK and so we were happy to offer that capacity to them to assist in increasing supplies to hospitals.

If an effective treatment is found, how can the industry ensure maximum possible patient access to it?

Again, collaboration is essential. If we return to the example of hydroxychloroquine, with the world running out of the raw ingredients to manufacture this COVID-19 investigational drug, Accord took the unprecedented step of partnering with another UK company, Sterling Pharma Services, to purchase and ship the raw materials required to produce hydroxychloroquine API in the UK. This means we have secured a domestic European supply that will help meet predicted European demand and ensure we are not reliant on imports, thereby helping ensure patient access.

Are there any other challenges in this environment that you foresee affecting you in the future?

One challenge will be to take the learnings from this pandemic and make sure that we are never in the same position again in terms of the drug shortages that healthcare systems have been facing across Europe.

Generic medicines have been viewed as a commodity like anything else; clothing, cars, computers, which is why so much of Europe’s supply chain is outsourced to Asia. Where purchase decisions are purely based on price, not value, the players in the market respond by driving efficiency savings via offshoring and gaining economies of scale. The corollary of this is massive aggregation of supply into a few very large, potentially fragile, supply chains. The situation reduces resilience, effectively putting all eggs in one basket.

From an industry-perspective, companies need to think about what their value proposition is at home and abroad. Governments will also need to look at this. We need to lobby to ensure procurement of medicine is not necessarily just focused on delivering the absolute lowest price, but also giving some weight to other attributes such as how diversified and resilient supply chains are, what the carbon footprint is like and safety or utility advantages. Within European public procurement, the concept of Most Economically Advantageous Tendering is already on the statute book, it just needs to be applied more wisely in the future.

About the interviewee

Dr James Burt has over 20 years plus experience in the pharmaceutical industry, predominantly in the generics and biosimilar sector. He joined Accord in 2010 and now leads the company’s operations in the EMENA territory, with particular responsibility for developing and delivering the company’s strategy to improve access to high quality affordable medicine within the region.