Everyone believes that patients in need of care should be able to access the best treatments as quickly as possible. But market access – the system that delivers this care all over the world – faced significant challenges even before COVID-19. The pandemic is now exerting even greater pressures on the global healthcare system.

Pharmaceutical and life sciences companies are dealing with slower trials, less authoritative data on outcomes, and issues around the safety of trial participants. Companies are under pressure to reallocate bandwidth and funding to coronavirus-related drug development, potentially harming innovation in oncology, heart disease and other critical health conditions.

In our last article, we covered some key current challenges for life sciences firms around intellectual property (IP) and patents. In this article we are looking at market access itself. We will examine new vulnerabilities in the long and difficult process of getting a drug or treatment to market. We will also investigate ways in which life sciences companies can respond to these challenges and create new, innovative solutions that work for patients and other stakeholders.

It is worth quickly defining what we mean by ‘market access’. Some characterise market access as starting once a drug is developed, covering later stages like regulatory approvals, pricing, launching the product and marketing. Others take a broader view, describing market access as the whole process including research and development (R&D) and trials, in addition to the stages described above. We are aligned with this view. For the purpose of this piece, we will use ‘market access’ to mean the entire journey of a drug or treatment, from early R&D efforts through to treating patients.

Generally speaking, market access comprises four broad stages:

• R&D and trials
• Regulatory approvals
• Pricing
• Product launch and marketing

Each of these stages is incredibly complex. Each has its own specific challenges, which are being exacerbated by COVID-19. But each also brings opportunities for innovation that can be leveraged.
 

R&D

In a world of limited resources, carrying out cutting-edge R&D is trickier than ever. As everyone in life sciences knows, R&D is by no means a quick process. The lead time from initial discovery to rolling out in the market can be up to ten years. By far the longest part of this process is the clinical trial stage, which can take as long as seven years to go from start to finish.

The amazing work done by scientists to respond to the COVID-19 pandemic is genuinely unprecedented, but in some ways it has created further difficulty. At short notice, pharmaceutical and life sciences companies began devoting significant time and energy to coronavirus research at the expense of other research projects. GlaxoSmithKline (GSK), for example, has decided to prioritise tackling COVID-19. With promising partnerships already struck with Sanofi and Medicargo to develop a COVID-19 vaccine, this may pay dividends for GSK. But it will no doubt constrain the firm’s wider R&D pipeline. Eli Lilly, Bristol Myers-Squibb and Pfizer are just a few other notable companies to have paused or delayed non-COVID-19 R&D efforts in recent months.

Clinical trials for non-COVID-19 treatments have also been severely disrupted. Laboratories have had to operate at reduced capacity with employees working from home. More than 2,500 trials were paused or delayed between January and May, with over half the postponements being attributed to COVID-19. Much of this is necessary, of course. Trial participants, especially in fields like oncology, may be seriously ill: these individuals are likely to be among the groups at highest risk from COVID-19. Changes to the trial process are essential in this context.

Even so, the disruption has flown under the radar because of the urgency of the COVID-19 research taking place. With less qualitative and quantitative data available due to cancelled and paused trials, companies may have to plot routes to market despite having less robust data, potentially increasing the risk of unfavourable regulatory outcomes. Disrupted trials do not mean disaster for patients tomorrow. This development has not yet been priced into valuations in the sector, but delays in 2020 risk serious upheaval in the years to come.

One positive is that companies, such as AstraZeneca, are collaborating with technology providers to improve the experience of remote trials. Better integration of technology into trials – and through the whole market access process – stands to benefit the sector through the pandemic and over the long term, showing that there is still room for innovation even in difficult circumstances.

Regulatory approvals

There is tremendous pressure on regulators to maintain the global pipeline of new treatments while operating in very unusual conditions. There is also likely to be a flood of COVID-19 and coronavirus treatment approvals, from generics and biosimilars through to vaccines, coming to market in the near future. Establishing a framework for rolling out these treatments safely and quickly demands creative thinking and robust adherence to existing standards.

Correctly, regulators reacted quickly to address managing trials when the crisis was peaking in late March, but this approach has inevitably led to delayed decisions. For instance, the decision on Novartis’s multiple sclerosis treatment ofatumumab had originally been scheduled for June, but has now been postponed to September. Novartis is not the only company suffering from delayed decisions.

Being flexible on guidance may hold the key to enhancing market access. The European Medicines Agency, together with the European Commission and the Heads of Medicines Agencies, published guidance on managing clinical trials that advised sponsors to carefully examine the necessity of starting new trials or recruiting new participants. The EMA’s document was last updated in April. With cases presently declining around Europe, the time may now be right to push for updated guidance that relaxes restrictions on what R&D can safely be started or resumed.

Every market is different, though, and regulators will need to be agile in order to respond to new contexts and challenges. Looking further ahead, regulators should anticipate trial data that may have been impacted in different ways by COVID-19. To what extent will they accept gaps in data and adjust their normal protocols? Flexibility will be highly prized by industry but should not get in the way of public health.

Pricing

COVID-19 has already placed new strain on global supply chains, creating worries about excessive pricing for vital goods like sanitiser, face masks and certain ‘hyped’ treatments. Price gouging has already made news in We have seen some relaxation of competition rules helping foster cooperation between countries. However, regulators remain very vigilant on price gouging and violations of competition law, as can be seen in ongoing investigations in Brazil and Greece.

When the first regulated COVID-19 treatments make it to market, drugmakers will be under intense pressure from governments and the public to make products as widely accessible as possible. This may meet resistance from firms that have sabotaged their own R&D pipelines to produce important new treatments at speed. Having said that, if COVID-19 treatments come to market with very low prices, the drive for margin may also lead to higher prices for other medications. A cancer patient suffering as an indirect consequence of low-priced COVID-19 products is not a desirable situation for any party.

Product launches

With drugs taking longer to get to market, pharmaceutical and life sciences companies are likely to be even more motivated to roll out new treatments quickly. Earlier this year, we discussed the profound economic benefits to life sciences companies of being first to market with generics. The principle will hold true for new treatments too, and COVID-19 is likely to be the biggest launch market in healthcare history. This raises the likelihood of companies taking any shortcuts available to get products out to market, including illegitimate methods like falsifying data.

In addition, governments are already starting to exert their financial and trade power to benefit their citizens. When it comes to COVID-19, the US and EU are both in discussions with drugmaker Gilead to secure their share of Gilead’s high-potential treatment remdesivir. The question of whether companies have a duty to ensure all countries have equitable access to their treatments is very complex. Should more treatments be directed to countries with higher infection levels? How can international organisations like the World Health Organisation manage these market dynamics while also engaging constructively with drug developers? Striking the right balance here will not be easy.

Summary: how to innovate in such a high-pressure situation?

Drug developers are dealing with stresses on almost every level, from day-to-day operations to high-level strategic business model changes. Market access has totally changed in the last few months, from R&D right through to pricing and product launches.

Even if pharmaceutical and life sciences companies face significant challenges in developing new treatments, there are opportunities to change market access for the better. For one thing, governments and regulators are also out of their depth: no one has experienced a situation like this in their careers. A spirit of collaboration and community, where information is exchanged and ideas shared, could foster closer bonds between organisations, governments, regulators and the public.

In particular, COVID-19 has sped up key technological developments, from digital consultations to conducting remote trials. This trend represents an opportunity to change the way life sciences companies communicate with patients. Traditionally, these relationships have been mediated through doctors, pharmacists or hospitals. But healthcare is becoming more personalised all the time. Companies should ask themselves the question: “Do the patients using our products truly understand why we do what we do?” By focusing on building new and productive dialogues with patients, the complex and inefficient market access process could be transformed for the better.

How A&M can help

A&M has a dedicated Health Care & Life Science practice to help you address the whole market access lifecycle and adapt to a rapidly changing industry landscape. In addition, A&M’s Disputes and Investigations practice combines deep experience in life sciences with specialist litigation and disputes support. Areas of expertise include advisory and investigations in fields including clinical trials, excessive pricing and responsible data management.

If you have any questions about the content covered in this article, please contact Jerry Lay or Iliana Jaeger.