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Drug regulators from across the globe convene in Dublin: EU “fortunate” to have fully integrated regulation

Describing it as a “significant event,” Minister for Health Simon Harris led the opening ceremony at the recent International Conference of Drug Regulatory Authorities 2018 (ICDRA). Welcoming over 500 delegates from over 100 countries, Mr. Harris said he “look[ed] forward to hearing about and acting upon the wider outcomes of the recommendations arising from the 2018 conference.” Recommendations from ICDRA conferences provide regulators and the WHO with a roadmap for developing future policy decisions.

Hosted this year in Dublin by the HPRA in conjunction with the World Health Organisation (WHO), a wide range of policy areas were discussed under the theme: Smart Safety Surveillance. It was the largest single global gathering of medicines regulators and the biannual event is one of the most important dates in the drug regulatory calendar. “The role of the regulator in safeguarding public health has never been greater,” Mr. Harris said. “The effects of a poor or mishandled regulatory system for medicines can be dangerous, as we have all unfortunately seen in the past.”

The event re-emphasised the responsibility of regulators to maintain constant vigilance – from product development to end use – and the problem of substandard and falsified products, which are a worldwide problem, featured prominently. Attendees also heard how regulators play a vital role in combating antimicrobial resistance and in helping to bring public health emergencies under control, such as during the recent Ebola crisis in sub-Saharan Africa. Health authorities in the Democratic Republic of Congo are still declaring new cases. Speakers welcomed an emerging emphasis on the need to achieve greater regulation in the area of medical devices.  

Delegates heard how regulatory authorities in different parts of the world operate at various levels of expertise and ability, but that under the umbrella of ICDRA their purpose is universal: to strengthen global collaboration and increase patient safety and access to health products in every corner of the world. But inequality of access to quality assured, life-saving medicines is an intractable problem and regulators from low and middle-income countries were well-represented on the day. The conference heard that some 42% of medicines in sub-Saharan Africa are falsified or substandard. Delegates were strongly encouraged to prioritise collaboration across borders to help to approve and register new health products more rapidly, ensuring faster access for patients.  

“In Europe, we are fortunate in having a fully integrated regulatory system, which provides some level of certainty and predictability around the authorisation of medicines,” Mr. Harris said. He also spoke about medicine shortages arising from production issues and commercial decisions, and flagged “unexpected” causes, such as the UK’s decision to leave the European Union.  

Emer Cooke is the head of regulation of medicines and other health technologies at the WHO. Formerly a quality assessor at the original Irish National Drugs Advisory Board, an organisation which predated both the Irish Medicines Board and the HPRA, Cooke told delegates that seeing ICDRA hosted in her hometown had “special significance” for her and said she hoped ICDRA Ireland 2018 would be a “safe space for regulators to speak freely about the issues that matter to them”. Dr. Mariangela Simão, assistant director-general for access to medicines, vaccines and pharmaceuticals at WHO also attended the conference.  

Emer Cooke criticised health systems for taking too long to approve products, saying it is a sign of “weak regulation”. This comes at a time when the Irish media is reporting on the concerns of the Irish Pharmaceutical Healthcare Association (IPHA), who claim that Irish patients are among the last in Europe to get access to new medicines. IPN recently reported that the IPHA believes the approval process for new medicines in Ireland is “frustratingly slow” especially given that certain products manufactured here are exported for use in other European nations, yet are still not sanctioned for use here. The IPHA claim that Irish patients are missing out on access to new cancer, cardiovascular and musculoskeletal treatment. Cooke told delegates that “a good regulatory system gives people the confidence that the medical products they need and use are safe and will work as intended. Conversely, a weak regulatory system undermines patient safety and access, for example, by taking too long to approve products.”  

Lorraine Nolan is the CEO of the Irish medicine’s regulator, the HPRA. Nolan explained how the Irish drug regulatory system has evolved. “The patients and the public we serve are changing hugely and that’s not just from the perspective of life expectancy but also in terms of the range and profile of chronic diseases. Patients are much more knowledgeable now than ever before and more empowered to take control of their own healthcare. They quite rightly want to understand how we make regulatory decisions and that requires us to have structures in place to be better able to give them that information, and that is the cornerstone of transparent regulation.

“We are a small country but collaboration has had immensely positive benefits for us as an agency, but most important of all, for our patients. We actively participate in the European system for medicines and medical device regulation. We feed into it through information, data, and our people – who participate at the highest level. Our structure enables us to operate on a network basis with the EMA and that includes all of the agencies throughout the 28 EU member states and the EEA countries. We have developed strong bilateral relations with many of our regulatory partners across the globe and we are keen to develop further participation and contribute in capability building in low and middle-income countries. Put simply, we invest in collaboration and partnership to make the global system of regulation stronger. I also believe our own story as a regulatory agency is somewhat special, and particularly how it has grown to encompass a broader remit and a greater number of regulatory functions. We are responsible for regulating a wide range of health products and these include human and veterinary medicines, medical devices, blood components, human tissues and cells and organ transplantations and cosmetics. We regulate manufacturing, wholesale and distribution companies, medical device notified bodies, as well as other health product facilities. The scale of that expansion has been quite dramatic for us. In the past 10 years we have doubled our staffing, invested entirely in workflow and electronic processing technologies, expanded our expertise across all the scientific and clinical disciplines and developed our business support functions, including quality systems, legal, HR – all to support our growth.”

 

Guido Rasi is the Executive Director of the European Medicines Agency. He congratulated the WHO and the HPRA for delivering and putting together a programme of “this depth and this complexity.” Rasi lamented the European Medicines Agency’s plans to relocate from London to Amsterdam, due to the looming spectre of Brexit. “Despite this challenge, the EMA are committed to continuing where we can our engagement to support the WHO and to further our support to regulators and networks in resource-limited regions. The cornerstone of the success of the EU’s regulatory model is strength through reliance. We know that no one single agency can do it all, no matter the size of its resources. We know this from our own experience and by working together we also learn from each other, taking the opportunity to further strengthen our network. We all face similar challenges, and so the need for cooperation between health bodies has never been greater than today.”

The last biannual ICDRA event was held in South Africa in 2016 and the opening ceremony famously ended in a celebration of traditional African music and dance. The 2018 event in Dublin did not disappoint in this respect and rather untypically for formal events like these, delegates ended the morning with an impromptu ceilí, prompting one organiser to joke, “this happens at all the conferences!”

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