Blog series: Maintaining Regulatory Momentum in the Covid-19 era:

It’s been a difficult year for many biopharma companies and perhaps even more so for clinical research organisations, with Covid-19 forcing the postponement or even cancellation of many if not most clinical trials.  It is however important to keep a finger on the pulse of the other imminent regulatory changes that will impact work programmes in this industry. In my last blog in this series (Orphan Unknowns: What the MHRA Guidance Will Mean After Brexit )  I highlighted things to watch out for in the Orphan Drug sphere in light of current Brexit transitions.

This year, with clinical trials expected to get under way again – thanks to the speed with which vaccines are being developed and approved — attention is again turning to the EU’s new Clinical Trial Regulation. The regulation has been delayed several times due to technical issues with the new EU Clinical Trials Portal and Database, but has recently been confirmed for implementation in December 2021, so it needs to be back on the radar of the Clinical Trials industry.

While there will be a transition period, and trials already under way can continue through the Clinical Trials Directive (CTD), there is a lot of work for companies to do to meet the CTR. Biopharma companies should be conducting impact assessments by now, because there could be months of remediation work that will have to be carried out to get up to speed with the regulation.

Sponsors outside of the EU will face more scrutiny with regards to their quality management systems. It’s important, therefore, to ensure staff have been properly trained on quality requirements and to instill a culture of compliance. That must come from senior quality people, and it will require well-structured processes and systems that take into account the regulations in all areas where the company is operating or plans to operate. Being inspection ready at all times will become imperative under the CTR, since EMA has made clear that their audits will be more vigorous.

There are a lot of nuances to a well-structured quality management system, so it’s important to have someone in-house – or work with a consultant — with a good understanding of the requirements. This person will need to bring that knowledge into the company and educate everyone on how their role impacts change control systems, corrective and preventive actions (CAPAs), and overall compliance. Sponsors will need to ensure your staff know the processes for reporting CAPAs and that your processes are properly designed and followed. Is their team members know the standard operating procedures? Do they know how to report anything that happens outside the CAPA systems? And are those properly managed?

Sponsors will also need to demonstrate clear decision-making processes when it comes to vendor selection. Are they auditing your vendors and CROs? Are they conducting proper feasibility studies? Are they asking the right questions? And how often are they independently monitoring CROs and research associates?

While the CTR affects all companies conducting trials in Europe, it creates more complexities for companies based outside of the EU that may not be used to working within the remit of EU regulations. Having a strong European partner on the ground in the EU who really understands these issues, can help you get up to speed and can enable you to build compliance into your organisation, will be even more important in future.

To help you stay abreast of such regulatory changes our Regulatory On-Call service provides personalised responses to your ad hoc regulatory enquiries by way of a monthly retainer, get in touch for more information. Also look out for the subsequent blogs in this series relating to Medical Device and General Data Protection Regulations; work programmes that have not gone away but may have drifted from focus in the current environment.

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Blog series: Maintaining Regulatory Momentum in the Covid-19 era:

In early December, the EMA announced that it had been hit by a cyber-attack and that documents related to the Pfizer-BioNTech Covid-19 vaccines had been accessed. The agency issued a brief announcement after the attack to say a full investigation had been launched but provided no further details.

The incident is a reminder to both regulators and companies of the importance of data security and adherence to the General Data Protection Regulation (GDPR), especially for companies transferring data outside of the EU that must adapt their data security systems.

Over the past year, the focus has largely been on bringing vaccines and treatments to market to address the Covid-19 pandemic. However, as we start to adjust to a post-Covid world, companies – especially those transferring data out of the EU – will need to ensure they understand and adhere to GDPR requirements for clinical trials within the EU.

Questions companies will need to ask include: Do they have the proper change control and access control processes in place? Do they have the appropriate software to detect whether they have been hacked? And for those countries operating in the UK, will data protection requirements stay within the GDPR or will new UK rules be introduced, and what new measures must they put in place to remain in compliance?

With so many complexities to consider, it is incumbent on companies to select an experienced data protection officer (DPO) to ensure compliance with the GDPR, for example that a suitable GDPR statement is included in all informed consent protocols for clinical trial subjects, that it is adhered to when including information about clinical trial investigators, and that all data management plans are adhered to.

There are other complexities that companies must consider when it comes to the GDPR and data protection. Although it is an EU-wide regulation, it is implemented differently in each country within the EU. For example, Germany has regional supervisory authorities in addition to a federal authority, meaning a study in one part of the country may have a different way of interpreting parts of the GDPR than one elsewhere in Germany.

Therefore, the DPO that a company works with needs to be able to adapt the advice based on these differences, and that requires the support of an experienced team of lawyers and clinical research experts.

As data privacy becomes a growing priority globally – for example, with the introduction of new data protection laws in China, India and Australia – life sciences companies will need to ensure they have the processes and technologies in place to meet current and future requirements.

To help you stay abreast of regulatory changes our Regulatory On-Call service provides personalised responses to your ad hoc regulatory enquiries by way of a monthly retainer, get in touch for more information. Also look out for the other blogs in this series relating to Medical Devices, MHRA Guidance on Orphan Drugs and the Clinical Trial Regulation (CTR); work programmes that have not gone away but may have drifted from focus in the current environment.

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A recent perspective piece published in the New England Journal of Medicine highlights an issue that I have long felt reflects poorly on the industry, and that is public mistrust in ’Big Pharma’.

This issue has come to the fore with the race to bring a Covid-19 vaccine to market. While the authors talk about the highly politicised nature of the vaccine, with attempts by the US Federal Government to push forward a vaccine before the November presidential elections (even if the manufacturer has not requested approval), the issue of public trust is a very real concern. Indeed, distrust is only serving to further fuel the rising problem of anti-science rhetoric.

Public perception of the industry has grown more and more negative in recent years, with rising criticism over companies’ business practices and behaviours. There are very valid reasons for that distrust, which boil down to transparency. This lack of transparency is sadly apparent in how the industry reports and shares clinical trial data, particularly negative study results.

Companies are supposed to report the results of all their studies, but all too often companies won’t invest in developing reports that show the outcome of molecules that failed to meet clinical endpoints. As the legal representative for companies, IDEA Regulatory is supposed to help ensure that sponsors publish those results but we have had experiences where we have chased clients to report the data, in keeping with the regulations, to no avail. Until now, there has been nothing to force companies to follow through since, although the regulations require that they report clinical study outcomes, there is no onus or punishment if they don’t.

Recently, the FDA announced a change in policy with plans to introduce fines for companies that failed to report trial results. My hope is that EMA will follow suit.

There are so many reasons why clinical trial transparency is crucial. Aside from regaining public trust, such data can help to prevent other companies from spending time investigating the same or similar molecules, or can provide guidance on what manufacturing adaptations could be made to build a better product, based on the pharmacodynamic and pharmacokinetic data from the failed product.

Not repeating the same mistake is not only about helping other companies avoid similar mistakes; it’s also about patient safety. Every time you carry out first-in-man trials to determine safety and dosing you put your patient volunteers at risk. If data is available to demonstrate how, when and why a product failed, other companies could avoid initiating a programme that is doomed to fail.

As an industry, we learn from achievements, but we can learn even more from mistakes since if we know what went wrong, we won’t keep repeating the same error over and over. Clinical trial transparency is about improving science and information and ensuring we provide patients with safe, effective products.

As an industry, we must work together to overcome conspiracy theories and the troubling anti-science movement, and there is no better way to do that than to be ethical and open. When companies do anything that is unethical, underhand or secretive – whether it’s skipping some of the testing or hiding data – it will put those companies at greater risk when problems arise and harm the reputation of the industry as a whole.

Let’s work collectively to make sure we share data that can help to eliminate future unnecessary mistakes, and bring back trust to an industry that does vital and life-saving work.

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When regulations change there are always a few aspects where the careful reader finds themselves asking “did they really mean that?”. In that vein there is a somewhat ominous clause in the new Clinical Trial Regulation, at least from the point of view of the legal representative.

Article 74 of the regulation states: “Such legal representative shall be responsible for ensuring compliance with the sponsor’s obligations pursuant to this Regulation, …..”. What that means is the EU legal representative now takes on the role of overseeing the sponsor’s compliance and potentially the role of “whipping boy” if the sponsor fails to fully step up to the line.

When the regulation was first published many believed that the decision of whether to require an EU legal representative would be made on a country-by-country basis. However, when asked about the basis on which the decision would be made the European Medicines Agency recently replied  “…the decision to appoint or not a legal representative in the EU, should the sponsor not to be based in the EU, will apply on trial-by-trial basis and would be at the discretion of the Concerned member states (CMS) where the sponsor intends to conduct the clinical trials”. This raises the very real possibility that the member states will look at the sponsor, and, based on their evaluation of them, decide an EU legal representative might only be needed in cases where there are concerns about compliance.

Perhaps not surprisingly, several of the larger and more risk aware clinical trial outsourcing companies (CROs) are starting to set strict stipulations regarding the role of the EU legal representative. They are declining to take on the role of the legal representative unless all clinical trial activity is carried out by them.

This cautious approach is understandable, especially for large businesses which have a lot to lose. Companies seeking legal representative support in the EU typically are smaller companies and have no presence in Europe.. Add to that the possibility that EU legal representatives will only be required for “riskier” trials then should something go wrong – however unlikely that is – the CRO partner stands joint and severally responsible for the failings of the sponsor. And that could be extremely costly.

Given that the EU legal representative role is not by any manner or means the most lucrative aspect service delivery to trials, it does seem like an unbalanced risk/reward profile for all but the most specialist providers to take on this role.

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The long-awaited new Clinical Trials Regulation looks set to be introduced in 2020. Initially adopted in 2014 and due to go into force soon afterwards, it was held up by technical difficulties with the database, which is necessary to underpin the new environment. The latest testing suggests these problems have been resolved.

The new regulation will provide a far more streamlined process for sharing clinical trial information, create a more efficient assessment process, and facilitate trials being conducted across multi-member states.

There is, however, one subtle, and easily overlooked consequence of the regulation, which is with regards to the EU legal representative. At the moment, any trial where the sponsor is outside of Europe requires a formal legal representative in the EU. Once the regulation is implemented, this will change – either making life easier for the sponsor or potentially adding a layer of complication that many have not foreseen.

If, on one hand, all the regulators who are dealing with the trial agree to do so, they can waive the requirement to have a legal representative requiring only a contact person instead. However, if they don’t agree then the EU legal rep will become a more significant role than it has been previously.

Under the new regulation, the legal representative will be responsible for the sponsor’s compliance with the regulations. In practice, what that means is the EU legal representative will have to provide quality assurance oversight across the full extent of the trial, including not only aspects conducted in the EU, but also those potentially conducted outside the EU but linked to the trial.

If we look at many of the life sciences companies that will need a legal representative – the small biotech companies with no presence in the EU – the reason for this change becomes clearer. These companies can have immature systems in place and are typically led by someone relatively new to the industry, or at least to their level of responsibility. The likelihood of something major going wrong is low, but far higher than if the sponsor was a major multi-national. Making the legal representative responsible for the sponsor’s compliance is a way for EU regulators to ensure that there is someone to pursue in all circumstances

That said, those companies offering EU legal representative services will need to closely assess the potential risks involved as the regulation moves closer to implementation and the portal goes live…

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I’m a huge believer that even in the very worst of circumstances, there is always a silver lining (or two) to be found. We  have already seen some of these playing out during this pandemic in the many ways people are coming together to spread hope and goodwill between and across communities. One positive that the coronavirus might bring specifically to regulatory processes for medicine and medical devices, is a shortening of response times from the regulatory authorities and better ways to share information simultaneously between global authorities, leading to improved harmonisation. The COVID-19 pandemic has forced regulators to find new ways of communicating on global projects and to act urgently to deal with this unpredictable and critical situation.

To address the coronavirus effort, regulators have adopted new processes and are making use of interoperable databases and systems to share information. They are using these systems and processes to ensure studies and data from coronavirus research are widely and rapidly shared in order to speed up the process of bringing vaccines and treatments to patients.

I certainly hope – and expect — that there will be some trickle down from those learnings once this crisis is over. Allowing the life sciences industry and academia to push forward with efforts to improve global harmonisation when it comes to sharing data and study results. More rapid, harmonised approaches will ensure that everyone in the research community is aware of what is working and what is not in each disease category so that discovery efforts and clinical trials aren’t focused on areas that have been shown to be ineffective elsewhere.

These next few months will be crucial for achieving the breakthroughs needed to tackle the pandemic, and good regulatory processes will be key to advancing those objectives. Times of crisis are often the catalyst for positive change and there’s every reason to be optimistic that this current sense of urgency will help us improve the regulatory landscape and lead to better processes for all breakthrough therapies in the future.

The fact is that, as an industry, we’re good at recording what we do day-to-day. It is what researchers do, and it’s part of our Good Practices – we carefully record data because if we don’t write down what we did and what we observed, it didn’t happen (according to the audit trail at least). If we record the learnings we gain from this period and transfer those to regulatory processes more generally, we can at least say that some good has come out of a very dark period in our history.

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