COVID-19 Pandemic in the EU: Fraudulent Medicines, Test Kit Shortage, & EMA Guidance Regarding Ongoing Clinical Trials
As of March 27, 2020
Each health authority within the EU has information regarding COVID-19 (coronavirus) on its website. In this blog we will try to guide you through some of these recommendations and measures. Please note that information changes rapidly. Always check the applicable websites (EMA, FDA, Health Authority in your country, Inspectorate, etc.) if you need more information.
Recent EMA-related COVID-19 (coronavirus) updates include:
Falsified, Fake, and Fraudulent COVID-19 Medicines on the Market
As the COVID-19 pandemic continues to unfold and grow increasingly severe across the globe, the number of people searching for a cure, treatment, and/or vaccine for the disease is extraordinary. It has recently been reported that a number of online vendors are trying to cash in on the crisis and the shortage of coronavirus test kits by selling fraudulent, falsified medicines claiming to treat or prevent COVID-19.
These fakers have managed to build unauthorized websites to exploit fears and concerns during this COVID-19 pandemic. It is important for everyone to know that there are currently no registered products for sale that are indicated for the treatment or prevention of COVID-19.
Shortage of Coronavirus Test Kits
Unfortunately, fake medicines are not the only bad news in the COVID-19 struggle. At the moment, some countries are experiencing a shortage of COVID-19 test kits used to diagnose the virus.
In the Netherlands, there is an acute undersupply. Although there are multiple producers, most of the Dutch laboratories are dependent on the test materials provided by the pharmaceutical group Roche. Part of the reason for this scarce availability of the tests is the fact that there is a so-called “vendor lock-in,” meaning that companies using the Roche machines must also use the accompanying Roche materials. However, Roche announced last Friday that it will release the recipe for its lysis buffer if Dutch laboratories ask for it. The Netherlands has appointed a special agent to work on the issue surrounding the supply of test kits. The best way to contain the virus is to follow the infections and take the appropriate measures, but that is not possible without an ample number of test kits.
The situation is similar in Spain and Portugal. Both countries are facing shortage of tests and reagents needed to perform them, but governments are managing to overcome the lack of test kits with international donations. In addition to low stock of tests, these countries are also facing a lack of healthcare professionals able to collect the samples and run the tests, which is the result of many healthcare professionals have tested positive for the virus, requiring them to isolate.
The UK encourages manufacturers/suppliers of CE marked professional use test kits, to contact the Medicines and Healthcare Products Regulatory Agency (MHRA), who will inform them whether or not their product can be placed on the market. They are developing specifications for SARS-CoV-2 tests and will make these available as soon as possible. The UK has published warnings on the use of products for the diagnosis of COVID-19 (SARS-CoV-2) infection in community settings, such as pharmacies. Public Health England (PHE) is not advising the use of these products. MHRA confirms that there are no CE marked tests approved for home use, and it is illegal to supply such products.
As the recipe for the novel lysis buffer is obtained, approvals will be needed before other companies can begin offering the test kits that they will be able to manufacture. At this point, time is of the essence and swift movement over these regulatory hurdles will be key. We have the experience and knowledge to help you obtain EMA approval as quickly and painlessly as possible. Contact us today to learn more about our services and how we can help you achieve successful interactions with the EMA.
In addition, as you move a majority of your resources to focus on recent demands brought on by the COVID-19 pandemic, we can help fill in the gaps, resuming work on your everyday projects so no time is lost and nothing is forgotten while you work to help during this extreme time of need.
Implications on the Methodological Aspects of Ongoing Clinical Trials
On March 25, 2020, the EMA published a draft guidance , entitled “Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials.” Due to the urgency associated with the COVID-19 pandemic, the document was published under a four-week public consultation. This guidance applies to Sponsors of ongoing clinical trials (CTs) affected by the COVID-19 pandemic and covers the actions that should be taken to ensure the integrity of their studies and interpretation of study results while safeguarding the safety of trial participants as a first priority. In addition, it complements Good Clinical Practice (GCP) guidance published on March 20, 2020, regarding “how Sponsors should adjust the management of CTs and participants during the COVID-19 pandemic.”
EMA’s Biostatistics Working Party (BSWP) encourages Sponsors to seek scientific advice on these matters in order to rest assured that these topics will be thoroughly reflected on during the assessment of affected clinical trial data submitted to EMA related to Marketing Authorization Applications (MAAs).
The BSWP raises the following major points for Sponsors whose ongoing clinical trials are or might be affected to consider:
- Pre-plan how systematic deviations resulting from the measures and individual decisions related to the COVID-19 pandemic are captured.
- The external validity of trial outcomes may be affected. Risk-assessment of the impact of:
- COVID-19 potentially affecting trial participants directly
- COVID-19 related measures affecting clinical trial conduct on trial integrity and interpretability is recommended.
An analysis is advised of the accumulating trial data in order to evaluate the implications on recruitment, loss of patients during the trial, ability to record data and ability to interpret the treatment effect in light of the pre-, during and post-pandemic measures phases. It is recommended that such an analysis of the trial data is conducted by an independent Data Monitoring Committee (DMC).
- Potential recommendations of this DMC include:
- How to re-start usual trial operations
- Additional measures when completing the trial after the pandemic
- The need to adjust the trial sample size
- Additional analyses
- Proposals to deal with any identified potential sources of bias such as missing values, newly identified intercurrent events or other unforeseeable required changes to trial elements.
Major changes in the conduct of a trial should follow the local regulations and be approved by Ethics Committees. Discussion with relevant competent authorities is encouraged and COVID-19 related guidance should be consulted.
Are you in the midst of a clinical trial? Although the COVID-19 pandemic certainly poses some challenges and there are some changes that must be made in order to adjust to the current regulatory landscape, it is not impossible and can be done as painlessly as possible. We are here to help ensure that this happens. To learn more about how we can help with your ongoing clinical trials, contact us today.
As of March 27th, the EU Clinical Trials Register lists 11 clinical trials that have been registered. Please keep in mind the urgent call of the EMA to combine as many trials as possible in order to compile a solid data set upon which to build registration opinions.
For those who want to keep track of COVID-19 publications, the World Health Organization (WHO) is gathering the latest scientific findings and knowledge on coronavirus disease and compiling it in a database. The database is updated daily from searches of bibliographic databases, hand searches of the table of contents of relevant journals, and the addition of other relevant scientific articles that come to our attention. The entries in the database may not be exhaustive and new research will be added regularly.
Our Experts are on Top of the Situation
Experts from The Weinberg Group, Southwood Research, and ProPharma Group are on top of this situation and can provide your company scientific advisory, specialized support on how to create/improve your Business Continuity Plan (BCP), handle investigational medication distribution, document deviations and propose actions to mitigate the risks. We are working remotely and totally able to provide this service during and post COVID-19 pandemic.
- If you are preparing solutions for the novel coronavirus, we are here to help. We have all the appropriate experience in house and can help prepare emergency petitions, expedite submissions for new indications, and apply for emergency use for drugs already in trials.
- If you are in the process of preparing for a meeting with EMA or FDA, we are here to help. Over the years, we have conducted a lot of successful EMA and FDA meetings, helping our clients achieve their goals. We are up-to-date with the accelerated procedures of the EMA and FDA in getting COVID-19 products to the market.
- If you are setting up COVID-19 related clinical trials, we are here to help. Our experts can guide you drafting clinical trial protocols and establish safety management plans for these studies. Our experts in (vaccine) pharmacovigilance are ready to help.
- If you are ongoing non-COVID-19 clinical studies, we are here to help. We our here to join you in managing the effects of the Corona crisis to keep your studies valid.
- If you run out of resources due to illnesses, we are here to help.