The Outlook for a Year of Change

Felicity Thomas;

Over the past 12 months, the bio/pharma industry has faced unprecedented challenges head on, working in unique and remote ways, and forming new and unlikely partnerships to help in the fight against the COVID-19 pandemic. Although a hugely impactful aspect of 2020, COVID-19 has not been the only trial of the year; bio/pharma companies have also had to keep a watchful eye on Brexit—the departure of the United Kingdom from the European Union—which is expected to cause broad-level disruptions to companies throughout the region. (See Sidebar.)

Editor’s Note: This article was published in Pharmaceutical Technology Europe’s January 2021 print issue.

The year ahead has the potential to provide a platform for change, as work and everyday life transforms in reaction to the pandemic situation and other important happenings of 2020, leading the bio/pharma industry to face a variety of new challenges and take advantage of various opportunities as well. “There are several challenges facing the bio/pharma industry in 2021,” reveals Kate Coleman, director quality and compliance, PharmaLex. “One of the challenges being faced is the realization that the working environment has changed irrevocably as a result of the COVID-19 pandemic. As with any major change, a new working environment brings about its own set of difficulties, such as GMP [good manufacturing practice] oversight and collaboration in a virtual world, as well as opportunities, such as a chance to challenge the status quo and demonstrate that even when things change it is still possible to be successful.”

A new five-year EU strategy

Towards the end of 2020, the Pharmaceutical Strategy for Europe was published (1); the aim of which is ensuring equitable access to medicines throughout the region and to support the industry’s competitiveness and innovation on the global pharmaceutical stage. “The coronavirus pandemic has highlighted the vital need to strengthen our health systems,” said Ursula von der Leyen, president of the European Commission (EC) in a press release on the strategy’s publication (1). “This [need] includes access to safe, effective, and high-quality medicines at an affordable price. In the challenging economic and social times, the EU is currently facing, the strategy adopted today will ensure that Europe and Europeans will continue to benefit from such medicines.”

The strategy has laid out various legislative and non-legislative actions to be launched over the coming five years (until 2025), covering the whole ecosystem of pharmaceuticals in addition to specific aspects of medical devices. Four main work strands have been highlighted: addressing unmet needs and ensuring medicine accessibility and affordability, supporting a competitive and innovative pharmaceutical industry in Europe, enhancing resilience of the industry, and ensuring EU pharma has a strong voice globally (2).

SIDEBAR: A brief overview of big-ticket European news in 2020

In January 2020, the European bio/pharma industry was celebrating a milestone anniversary—25 years of operations for its regulatory authority, the European Medicines Agency (EMA) (1). The region was also starting the transition phase of Brexit, where preparations for the UK’s departure from the EU were underway and the respective governments started the first steps towards the negotiation table for a prospective EU–UK deal (2).

On 11 March 2020, with rapidly increasing cases of novel coronavirus being reported outside of China, the World Health Organization (WHO) made the assessment that COVID-19 could be characterized as a pandemic (3). A few days later, on 18 March 2020, EMA and the US Food and Drug Administration (FDA) co-chaired the first virtual global regulators meeting to discuss regulatory strategies to streamline vaccine development for COVID-19 under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) (4).

EMA established a task force to ensure a coordinated response to the pandemic and to review available scientific data on medicinal candidates early in April 2020 (5). Additionally, in April, global scientists, funders, and manufacturers signed a declaration for the collaboration of efforts to develop a COVID-19 vaccine (6).

By the end of April, news had broken of the collaboration between AstraZeneca and the University of Oxford on a COVID-19 vaccine (7). In other news, EMA also recommended the suspension of all ranitidine medicines within the EU as a result of the presence of low levels of N-nitrosodimethylamine (8). EMA’s final opinion on nitrosamines was published in July 2020 (9), which set out measures for companies to take in order to limit the presence of nitrosamines in human medicines. Additionally, the agency started its review of dexamethasone as a treatment for COVID-19 (10).

During August, several deals were struck between companies developing promising COVID-19 vaccines and the UK government and the European Commission (EC) for the supply of doses as the vaccine candidates started entering later stages of development. Moreover, it was announced in August that 172 economies were engaged in discussions to participate in COVAX, the vaccines pillar of the Access to COVID-19 Tools Accelerator—a global initiative co-led by the Coalition for Epidemic Preparedness Innovations, Gavi, the Vaccine Alliance, and WHO aimed at ensuring equitable access to COVID-19 vaccines (11).

Emer Cooke was appointed as the executive director of EMA in November 2020 (12). Cooke was nominated in June 2020 and is the first woman to lead the European regulatory body. The EC also published the Pharmaceutical Strategy for Europe in November, setting out key objectives for industry over the next five years (13).

Early in December, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) was the first to grant temporary authorization for the emergency use of the BNT162b2 vaccine from Pfizer and BioNTech (14). EMA issued its recommendation a couple of weeks later with the European Commission quickly granting the authorization, making the vaccine available across the EU (15).

A trade deal was finally struck between the UK and EU on 24 December 2020, worth £660 billion (€731 billion), after months of Brexit negotiations (16). And, on the penultimate day of 2020, MHRA granted emergency use approval for AZD1222 COVID-19 vaccine from AstraZeneca and Oxford University (17).

References

1. EMA, “EMA Celebrates 25 Years Advancing Public and Animal Health,” ema.europa.eu, 27 Jan. 2020.
2. EC, “Future EU-UK Partnership: European Commission Takes First Step to Launch Negotiations with the United Kingdom,” ec.europa.eu, 3 Feb. 2020.
3. WHO, “WHO Director-General’s Opening Remarks at the Media Briefing on COVID-19—11 March 2020,” who.int, 11 March 2020.
4. EMA, “Global Regulators Map Out Data Requirements for Phase I COVID-19 Vaccine Trials,” ema.europa.eu, Press Release, 24 Mar. 2020.
5. EMA, “EMA Establishes Task Force to Take Quick and Coordinated Regulatory Action Related to COVID-19 Medicines,” ema.europa.eu, Press Release, 9 April 2020.
6. WHO, “Public Statement for Collaboration on COVID-19 Vaccine Development,” who.int, Press Statement, 13 April 2020.
7. AstraZeneca, “AstraZeneca and Oxford University Announce Landmark Agreement for COVID-19 Vaccine,” Press Release, 30 April 2020.
8. EMA, “Suspension of Ranitidine Medicines in the EU,” ema.europa.eu, Press Release, 30 April 2020.
9. EMA, “EMA Finalizes Opinion on Presence of Nitrosamines in Medicines,” Press Release, 9 July 2020.
10. EMA, “EMA Starts Review of Dexamethasone for Treating Adults with COVID-19 Requiring Respiratory Support,” Press Release, 24 July 2020.
11. GAVI “172 Countries and Multiple Candidate Vaccines Engaged in COVID-19 Vaccine Global Access Facility,” gavi.org, Press Release, 24 Aug. 2020 [Updated 4 Sept. 2020].
12. EMA, “Emer Cooke Takes Office as Head of EMA,” ema.europa.eu, Press Release, 16 Nov. 2020.
13. EC, Pharmaceutical Strategy for Europe (Brussels, 25 Nov. 2020).
14. Pfizer, “Pfizer and BioNTech Achieve First Authorization in the World for a Vaccine to Combat COVID-19,” Press Release, 2 Dec. 2020.
15. EMA, “EMA Recommends First COVID-19 Vaccine for Authorization in the EU,” ema.europa.eu, Press Release, 21 Dec. 2020.
16. UK Gov, “Prime Minister’s Statement on EU Negotiations: 24 December 2020,” gov.uk, Speech, 24 Dec. 2020.
17. MHRA, “Oxford University/AstraZeneca COVID-19 Vaccine Approved,” gov.uk, Press Release, 30 Dec. 2020.

Each work strand features its own flagship initiatives and actions for industry that will enable the delivery of tangible results. As a whole, the strategy will be synergistic with the European Industrial Strategy (3) and will complement the European Green Deal (4).

A key aspect of consideration in both the Pharmaceutical Strategy and the Industrial Strategy of Europe is digitalization, which is hoped to be useful in lowering carbon footprints across the region. For Coleman, a hot topic in the coming year will be the adoption of Industry 4.0, disruptive technologies, and the implementation of other cutting-edge technology. “There are also huge opportunities to look at how we operate, focus on the things that are important, streamline our processes, and build in quality compliance so that we leave room for people to innovate rather than managing cumbersome systems and processes that don’t add value,” she adds.

Existing vulnerabilities

As discussed in the EU’s Pharmaceutical Strategy, COVID-19 has demonstrated vulnerabilities in the pharmaceutical industry supply chain and manufacturing capacity (2). With the majority of ingredients for treatments are sourced from offshore manufacturers, in China and India for example, disruptions to supply as a result of country lockdowns and factory closures were inevitable. More than half (51.3%) of the European respondents to the December 2020 Pharmaceutical Technology survey revealed that operations to their organization were affected as a result of disruptions to supply of materials or equipment (5).

“The disruption to the global pharmaceutical supply chain caused by the first wave of COVID-19 led to calls by a number of governments in Europe and elsewhere, such as the United States and India, for their nations’ pharmaceutical companies to onshore their API supply,” explains Tony O’Sullivan, chief commercial officer, ChargePoint Technology. As a result, O’Sullivan continues, many pharma companies have already started taking steps to localize supply chains, which is a trend he believes will become permanent.

Mark Quick, executive vice-president—Corporate Development, Recipharm, agrees that it is unsurprising that companies have started localizing and diversifying API partnerships to make supply chains more resilient in the event of any future shocks. “In 2021 and beyond, more companies will rethink their supply chains, favouring more local or regional partners,” he says. “It is also likely that ingredient suppliers and other contract organizations will look to expand their local presence in their target markets to cater to their customers onshoring their supply chains.”

Working remotely

The COVID-19 pandemic has proven the adaptability of the industry to work in ways that were not originally considered suitable. Two-thirds (66.7%) of European respondents to the Pharmaceutical Technology survey experienced changes to their work schedules to be able to socially distance while working, and nearly three-fifths (59%) worked remotely from home (5).

According to Coleman, industry has not only survived but has thrived in this aspect, demonstrating the ability to audit sites from different continents, collaborating effectively with partners from all over the world, and trusting the workforce to get the job done in a remote capacity. “One of the aspects that will permanently change for the industry is the knowledge that it is possible to keep things going despite any obstacles in the way,” she notes. “Within days, industry moved from being on site as standard to remote working if not required on the manufacturing floor. Expertise with the technologies that allowed us to work virtually was built up and even conferences and events moved online successfully.”

Virtual GMP inspections was a topic broached by Pharmaceutical Technology Europe’s regulatory columnist Sean Milmo in December 2020 (6), as calls have been made to make these a permanent alternative to on-site inspections for the future. However, Milmo cautioned that in order to make virtual inspections a permanent reality, it would be necessary to have unimpeded exchange of information between regulatory agencies and companies, which could be a lengthy process.

From a tablet manufacturer’s perspective, there has been an impact on the way employees are trained. Javier Raposo, sales and marketing director of I Holland, highlights that training is a vital aspect for tabletting companies as staff must be proficient in the process and understanding of the practices required to manufacture large quantities of tablets quickly and efficiently. “Training, which was once completed in a classroom setting or through one-to-one tutorials is becoming less desirable or deliverable because of COVID-19,” he says.

As a result, online learning tools have surged in popularity, Raposo continues. “This learning method is proving to be an effective answer to improving staff knowledge and understanding of tablet manufacturing without the need to leave their workplace, or indeed home,” he adds. “Online learning can also be easily adapted to changing regulations, requirements and operating procedures, and used for troubleshooting.”

The move to remote and online practices has both positive and negative connotations, Coleman emphasizes. “The positive aspect of working remotely is that the industry had to put the patient first, mobilize, and adapt to the new normal as quickly as possible, with support from regulators, to ensure supply kept going,” she says. “The negative side of this is that we have learned that we can do everything online without interacting in person and this brings its own challenges for networking and social collaboration.”

For regulators, it has been important to adapt the guidelines so that operations could continue while still ensuring minimal risk to the patient Coleman adds. “During the pandemic this has worked successfully and will encourage the industry to focus on the risk to the patient as the primary decision-making factor and to be pragmatic about everything else,” she says.

Brexit uncertainty continues

Despite the Brexit deal, which was agreed upon in the last few days of 2020 (7), there is still uncertainty over how the UK’s departure from the EU will ultimately impact the pharma industry and the wider economy. “There will be many impacts as a result of Brexit, several of which will be easily understood by everyone in Europe such as the need for EU-based legal entities for companies that previously operated out of the UK,” explains Coleman. “However, there will also be subtle impacts with more local effects and impacts that we may not have identified yet.”

A prime example of a subtle challenge for the industry is the packaging of medicinal products, Coleman continues. “Historically, UK and Ireland products were packaged together with English product information leaflets, but now, after Brexit, there are three territories, Ireland, Northern Ireland, and Great Britain with different requirements where historically there was one,” she says. “This [increase in requirements] brings challenges in terms of economy of scale and of managing supply into Northern Ireland which is part of the UK politically but is subject to EU regulations when its counterparts in Great Britain are not.”

Another factor is a potential divergence between the UK and EU, which although is not anticipated to be an immediate impact is expected to occur over time. “It is likely that industry will see a greater divergence between the regulatory regimes in the two markets,” asserts Marcelo Cruz, director business development and marketing, Tjoapack. “This [divergence] will have an enormous impact not just on the drug development stage, but also on the development of medical devices, drug delivery systems, and the packaging medicines are delivered in, as different formats may well be required in order to continue trading in the UK and EU.”

Over time, pharma companies will need to monitor any divergences to ensure compliance with the respective standards of both markets, confirms O’Sullivan. A certain level of divergence between the regions is already apparent with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) issuing its approval of the Pfizer and BioNTech COVID-19 vaccine prior to EMA (8).

“Furthermore, the UK will now be a smaller individual player in the industry as opposed to part of a larger collaboration when it was part of the EU and it will be interesting to see the impact of this for the UK, particularly when it comes to availability of medicinal products in the future or investment from pharmaceutical companies that may look at access to the EU market as one of their criteria for investment,” remarks Coleman.

Managing change

During 2020, the world became ‘smaller’ as working environments transformed to more online and remote locations and social interactions were limited. However, with the huge changes, new opportunities in supply chains, the establishment of new legal entities in the EU, and collaboration between global regulatory authorities have opened up, offering limitless prospects for the industry, Coleman observes.

Overall, the majority (72.5%) of European respondents to the Pharmaceutical Technology survey are positive that bio/pharma industry business prospects in 2021 will improve (5). More than half (57.5%) were similarly optimistic about their own company’s business prospects for the coming year (5).

“Managing all of the change brought about by the pandemic, in addition to the emergence of rapidly changing technologies, regulatory guidance changes, Brexit, Industry 4.0, and the journey towards personalized medicine, is the biggest challenge of all,” Coleman summarizes. “Now is the time for everyone in the industry to challenge their change management programmes and to ensure they have support structures in place to support resilience in the face of change.”

References

1. EC, “Affordable, Accessible, and Safe Medicines for All: The Commission Presents a Pharmaceutical Strategy for Europe,” ec.europa.eu, Press Release, 25 Nov. 2020.
2. EC, Pharmaceutical Strategy for Europe (Brussels, 25 Nov. 2020).
3. EC, A New Industrial Strategy for Europe (Brussels, 10 Mar. 2020).
4. EC, “A European Green Deal,” ec.europa.eu [Accessed 4 Jan. 2020].
5. Pharmaceutical Technology, 2021 Bio/Pharmaceutical Development and Manufacturing Employment Trends Survey (December 2020).
6. S. Milmo, “Inspecting GMP at a Distance,” Pharm. Tech. Eur., 32 (12) 6–8 (2020).
7. UK Gov, “Prime Minister’s Statement on EU Negotiations: 24 December 2020,” gov.uk, Speech, 24 Dec. 2020.
8. MHRA, “UK Medicines Regulator Gives Approval for First UK COVID-19 Vaccine,” gov.uk, Press Release, 2 Dec. 2020.

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When referring to this article, please cite it as F. Thomas, “The Outlook for a Year of Change,” Pharmaceutical Technology Europe 32 (12) 2020.