How does a world-leading pharma company make sure it is delivering the drugs its patients really need, when they need them? For Roche, part of the answer to that question lies in its commitment to an open dialogue with regulators.
“The regulators are in a position where they see a lot of things we don’t, because they have the benefit of seeing what’s coming in from everywhere,” says Jerry Cacia, head of global technical development at the Swiss conglomerate. “We learn as we interact with them.”
Governments often clash with the private sector on policy, but the pharma and biopharma industry has fostered a healthy relationship with regulators in its bid to ensure the supply of safe, life-saving medicines to people the world over.
The rapid rollout of Covid-19 vaccines is a case in point. Vaccines often take close to a decade to reach the market after years of clinical trials, safety checks and approval processes, but this time certain regulatory mechanisms have allowed much faster authorization.
Making regulation work for biopharma
In Singapore, for example, the Health Sciences Authority approved interim authorization of the mRNA vaccine developed by US pharma giant Moderna under what is known as the Pandemic Special Access Route, which allows for an adaptable, rapid response to an emergency.1 China’s medical products regulator, meanwhile, has approved vaccines for public use in a similar way, allowing the likes of Beijing-based Sinovac Life Sciences to race towards its goal of producing more than one billion doses annually.2
“I give nothing but praise and credit to the regulators of our industry, because they have been very flexible with companies that are doing the right thing,” says Cacia. “We see this happening globally, and it is really important that it continues.”
Cacia’s sentiment resonates with many. Research from Cytiva’s Global Biopharma Resilience Index has shown us how different parts of the pharma and biopharma industry are performing, but none have fared quite as well as government policy.
Chart 1. Policymakers have worked in tandem with the private sector to make pharma and biopharma regulation a strong point
Roche is a key producer of biologics, and it has taken the lead in manufacturing these specialized drugs through an information-sharing process with regulatory bodies globally that has made sure there are no blind spots in its understanding of everything from safety to demand.
Resilience at home is a priority
That support is not just limited to work that is dictated by demand in a globalized system: 65% of executives in the research say that their country is pursuing policies that actively encourage domestic research and development (R&D) and manufacturing. Domestic resilience is a priority for governments.
Policymakers recognize the value of R&D and manufacturing carried out locally. About two-thirds of executives say that laws in their own country related to intellectual property rights and protection are effective in helping them develop and produce new drugs. When drugs are produced locally, regulators seem to understand firms’ commercial imperatives: 63% of the respondents say that their country’s trade and tax policies are not an impediment to the export of drugs.
But there are areas where policy could do more. Among these is funding for start-ups and other pioneers. Less than 20% of respondents say that public funding, as well as private funding, is ‘very supportive’ of start-ups. And 21% say that state funding of research at public institutions fails to translate to improved drug production outcomes.
How to make regulation work for everyone
Regulation strengths are not limited to countries with a high GNI per capita (see chart 2). China, Russia and India, which are countries with a lower GNI per capita than other countries surveyed, managed to stay level on their index score with the likes of France, Japan and Singapore.
Chart 2. Regulators in lower GNI per capita countries are managing to keep pace with higher income counterparts
According to Dr Chris Chen, chief executive at Chinese firm WuXi Biologics, there was once a “disconnect” between China and other regulatory bodies that was difficult for companies to navigate. That has almost vanished, he says.
“Regulatory reform means that right now, China is very close to the global regulatory system, but five to 10 years ago it was very different,” says Chen. “You almost had to do two sets of work: you did all your research for China, and you did additional research for US and Europe. That disconnect is pretty much gone.”
For Kiran Mazumdar-Shaw, executive chairperson at Biocon, the pandemic showcased activity that indicated how versatile regulators and companies can be when they work together. But she believes that more could be done to ensure this applies to the industry as a whole — particularly for smaller companies that may be deterred from going to market because, she suggests, “It is just too expensive to take an idea from lab to market”.
“We should go beyond Covid-19 to apply these various models that evolved during the pandemic, to bring drug development or vaccine development or diagnostic development from lab to market very, very rapidly,” says Mazumdar-Shaw. “If you were to compress regulatory timelines, then that lab-to-market journey becomes much easier and less expensive.”
In Mazumdar-Shaw’s view, regulation needs a “common sense” approach. She points to harmonization of regulatory systems as one obvious improvement. Chen agrees, and says he hopes there will one day be a “global, uniform regulatory system”. Recent years have seen an increase in harmony, with organizations able to follow technical guidelines from a more commonly shared set of rules, but there continue to be differences in approvals from country to country.
In conversation with
Professor of Pharmacology at King’s College London
We sat down with Clive Page, a leading professor of pharmacology in London, to find out what Mazumdar-Shaw’s “common sense” approach to policy might look like in the UK, and what practical steps would help to ensure that policy works for all.
How do you set up policy to encourage companies to scale up in the domestic market?
There has been plenty of encouragement to get innovation off the ground. There are grants and lots of schemes if you are an academic or a small company.
But once it gets to a certain point, then you have to partner with a big organization. And there are very few of them left in the UK that are really UK companies. You are inevitably going to have to scour the globe for the best deal for your shareholders or your institution.
What should the UK do to ensure that companies can scale up over the long term?
We should be making sure we have sufficient capacity to help companies build locally in the UK. And then we have to help them become global distributors of medicines when they have found something that works.
At the moment, we are really good at the first bit, but then we sell it off too cheaply. So I think the scale-up agenda that people are talking about — getting manufacturing and the right expertise to take innovations forward in the UK — actually makes sure that we retain better control over companies. Looking at the next 10 years, I think this is important.