Keep it clean: Drug testing in athletics
At the time of writing this, the IAAF (International Association of Athletics Federations) World Championships 2011 are in full swing in Daegu, South Korea. With thousands of athletes competing against each other to be the World Champion in their athletic specialties, they will have done all they can to ensure they perform at the top of their game.
Unfortunately, it has been known for the pressure and desire to add another medal to the shelf to become too much for some athletes, leading them to turn to performance enhancing drugs in their quest for glory.
It goes without saying that the taking of anything that can boost an athlete’s performance, not just in athletics but in any sport, is taken very seriously. Athletes are subjected to both random and scheduled blood testing and if an athlete tests positive for a banned substance, they face either a temporary or permanent ban from their sport or in some cases, a prison sentence.
This year’s World Championships were full of world firsts. Before the event began, the IAAF announced its zero-tolerance approach to drug cheats and for the first time in the history of the Championships samples from every accredited athlete were stringently collected and tested. In total the IAAF collected 1,848 blood samples, representing “a sample from each participating athlete at the World Championships.”
The move by the IAAF forms part of its efforts to introduce a ‘biological passport’ to athletics, similar to that used by cycling authorities around the world. The collection of such a large number of blood samples by the IAAF was in addition to the usual 500 urine tests carried out by the World Anti-Doping Agency (WADA) during the competition. The Federation said its focus on and intolerance against drug cheats forms “the core of the IAAF's development of an Athlete Biological Passport.”
Meanwhile, the President of the IAAF, Lamine Diack, said: “The IAAF is proud of its total commitment to the fight against doping in athletics and this initiative will stand us in very good stead as we re-double our efforts going forward.”
In another world’s first occurrence and perhaps, given the subject of this article, an ironic one, was ‘Blade Runner’ and South African Paralympian, Oscar Pistourius, competing against able-bodied athletes. After a landmark ruling in 2008 by the Court of Arbitration of Sport, Pistourius has been allowed run in the World Championships and Olympics, should he meet the qualification times. The decision permitting Pistourius’ involvement in the Championships is ironic because the decision has attracted huge amounts of criticism, with some saying his Össur Flex-Foot Cheetah blades gives him an unfair advantage against other athletes.
For now though, let’s go back to subject of drug testing. By the start of the World Championships on 27 August two athletes; Jamaican sprinter Steve Mullings and American sprinter Mike Rodgers were both disqualified from the competition after testing positive for masking agent Furosemide and banned stimulant methylhexaneamine respectively.
Although the WADA is on a mission to lead a “collaborative campaign for doping-free sport”, during this year’s championships some claimed that there are certain countries employing more stringent drug testing regulations than others.
According to British newspaper the Daily Mail, Travis Tygart, the Chief Executive of the US Anti-Doping Agency, voiced his opinion on the differing standards of drug testing procedures and programmes across the world. Tygart was quoted as saying: “There does currently exist a divide between a number of nations that are running the most effective programmes. You look at the UK, France, Norway and, hopefully, the US. They are in stark contrast to the quality of the programmes in Spain, Jamaica, Russia. That's troubling particularly because our athletes will be on the world stage competing against those athletes.
“Frankly, athletes from those countries [Jamaica, Spain and Russia] deserve to be able to say: ‘Hey, we're clean and not only are we clean but we're held to the highest standard.’ I feel bad for athletes from those countries, because they don't have the ability to say that.”
Meanwhile, commenting on the anti-doping policies used specifically in the UK athletics scene, British Olympic athlete Marilyn Okoro, told Healthcare Global: “We’ve got a very good system in place in the UK; you have to make yourself available for one hour every day where you can be randomly tested. They do have a system where they come out of hours, so it is completely random, they can come to your home or training venue. It is important to make sure that we are going to the Championships clean and we can hold out heads up high and say ‘we don’t cheat’. I think it’s a massive thing and I think a lot more countries could do with a system like ours.”
David Howman, WADA’s Director General on its network of accredited testing labs:
The WADA’s Doping Control Process for Athletes:
Medical device companies: how to prepare for Brexit
Over the last decade, medical device businesses have been no strangers to regulatory changes and new compliance requirements. Companies with devices in the EU market have been working hard to achieve conformity with the requirements of the EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR), but the UK’s exit from the EU, effective as of 1st January 2021, demands yet another change: to comply with the new UK regulatory regime.
The Medicines and Medical Devices Act passed into law on 11 February 2021 does just that; it enables the UK to build its own regulatory system, although when this new framework will be fully in place is not yet known.
The transition to the UK’s new regulatory regime officially began on the 1st of January 2021, and with it a series of deadlines and phases that medical device manufacturers exporting to GB and Northern Ireland would do well to take close notice of. During the transition period, the UK Medical Devices Regulations (UK MDR) 2002, not to be confused with the EU MDR, will continue to apply in England, Scotland and Wales, whilst CE marked medical devices will still be accepted up to 30th June 2023.
The conformity assessment processes defined in the UK MDR 2002 (as amended) will require that medical devices carry the UKCA mark for entry in the GB market or the UKNI mark for entry in Northern Ireland (where the devices are not CE marked for the EU). In Northern Ireland, where the rules for placing a device on the market differ, the EU MDR and IVDR will apply in 2021 and 2022 respectively, in line with the EU’s implementation timeline.
This easing-in period of transition is valuable time that should be used productively by manufacturers to ensure that they get up to speed, keep up with relevant updates and prepare strategies and product portfolio for the next phase. To do this, businesses should make sure they consider the following areas as they assess their strategy for UK market access:
Potential Overlap with EU MDR and IVDR
Medical device manufacturers have been working to implement measures to ensure they comply with EU MDR and IVDR for quite some time. The experience, processes and objective evidence that they have gathered in these efforts are certain to be of use when applying for UKCA marking.
Product portfolios and new product pipelines should be evaluated against both overall compliance risk and commercial and strategic value. By identifying the regulatory compliance status for each product for the UK market and the efforts required to maintain that compliance, manufacturers can plan to use the grace period up to June 2023 to complete their activities. These plans should also be evaluated in consideration of the commercial importance of the individual products to help prioritise the workload. This may well result in the decision to discontinue certain products in the UK or to introduce new products on the UK market ahead of other markets.
Engage with Approved Bodies
This activity cannot take place too soon; as of the 1st of January 2021, UK organisations that were acting as EU Notified Bodies have become Approved Bodies in the UK, while EU Notified Bodies are no longer able to provide conformity assessments under the UK regulations. As there are currently only three UK Approved Bodies offering this service, there is a very real risk that latecomers will struggle to find a UK Approved Body to carry out the conformity assessment required to attain their UKCA mark in time.
Just as EU Notified Bodies are no longer relevant to pursuing UK certifications, UK-based Authorised Representatives are no longer valid when CE marking against the MDR or IVDR. Manufacturers using UK-based EU Authorised Representatives must switch to an EU-based Authorised Representative.
For the UK market, the role of the EU Authorised Representative is also no longer applicable. Non-UK manufacturers must have a UK-based Responsible Person (UKRP), which is equivalent to the EU Authorised Representative in terms of roles and responsibilities. Only one UKRP may be appointed, unlike EU Authorised Representatives, and they must have a registered place of business in the UK in order to register with the MHRA. Approved Bodies may be able to provide details of organisations acting as UKRPs and once this role has been assigned it will be critical for manufacturers to determine exact procedures for managing documentation and that clear communication channels are established.
Labelling and Import/Export
New UK regulations require that medical devices bear a UKCA mark in addition to the name and address of the UKRP for non-UK based manufacturers. Manufacturers who use the same products/packs for the EU and UK markets will need to consider the impact of adding more content to their labels in terms of usability for the supply chain and end-users.
While CE marking and certificates will continue to be recognised by the UK until June 2023, import/export administration is likely to change and become more burdensome. Manufacturers using separate products for GB (UKCA) and the EU and Northern Ireland (CE marked) will need to plan for how to ensure that the CE marked product is not shipped to GB post June 2023. Ensuring that processes and resources are in place to deal with developing situations will help manufacturers hit the ground running.
Many businesses will find that clinical investigations are carried out across multiple sites, some of which are outside the UK. In these instances, manufacturers will do well to have a plan for implementation and management of investigations, in compliance with local requirements. It is likely that the MHRA will also continue to update their requirements for clinical trials in the UK.
Data Protection and Standards
New tensions are emerging between the EU and the UK concerning UK data protection rules and the EU’s General Data Protection Regulation (GDPR), suggesting that maintaining ‘equivalency’ may involve a number of different phases.
Compliance with applicable standards also requires close attention; the list of designated standards for medical devices issued by the UK’s Department for Health and Social Care is based on the list of harmonised standards published in the Official Journal of the EU, which in turn are harmonised to the MDD, AIMDD and IVDD. More recently published standards, however, have not been harmonised to the latter European directives and are thus not in the UK’s designated list, despite being considered state of the art. It would be prudent for manufacturers to monitor the state-of-the-art standards and apply where applicable, rather than rely on superseded and outdated standards.
As the UK moves into a new regulatory regime, medical device manufacturers who have already invested time and resources to comply with EU MDR and IVDR can use this to attain their UKCA mark. However, a dynamic compliance environment combined with the new onus relating to export policies means that close attention needs to be paid on numerous fronts. Keeping pace with this changing environment will ensure that manufacturers face the future with confidence and do not lose important space on their markets.