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Driving forward medicines regulation

07/05/2017

The Health Products Regulatory Authority (HPRA) is at the centre of Ireland’s bid to provide a new home for the European Medicines Agency (EMA). David Lynch spoke to HPRA Chief Executive Ms Lorraine Nolan about the Authority’s overall programme of work

In early 2015, Ms Lorraine Nolan succeeded Mr Pat O’Mahony as Chief Executive of the Health Products Regulatory Authority (HPRA). The coming months will surely be among her most hectic in the role to date. The Authority is heavily involved in an inter-departmental bid that the Government has made for Dublin to become the new site for the European Medicines Agency (EMA), which is currently located in London. Speaking to the Medical Independent (MI), Ms Nolan sounded confident about Dublin’s chances, although the decision will ultimately be a political one made at European Council level.

However, part of Ms Nolan’s confidence comes from what she regards as the “very big footprint within the European system for medicines regulation” that the HPRA has made. The Authority is well represented on important committees within the EMA and “we have played a very strong leadership role” within the European agency, says Ms Nolan.

“In terms of supporting the EMA into the future, I really believe that the HPRA is very well equipped to actually perform that role as a host agency.” Ms Nolan is a chemist by training, having completed her PhD and post-doctoral research in transdermal drug delivery at Trinity College Dublin. She worked for a number of years in private industry and joined the HPRA in 2001. Since that time, she has held a number of roles at senior level within the organisation, while she is also a member of the management board of the EMA.

The remit of the organisation that Ms Nolan leads has become wider in recent years. The HPRA regulates medicines, medical devices and other health products. The ‘products’ under its remit include human and veterinary medicines, medical devices, blood and blood components, tissues and cells, and organs for transplantation.

Vigilant

One of the Authority’s central functions remains the seizure of illegal medicine. A total of 673,906 dosage units of falsified and other illegal medicines were detained by the HPRA’s enforcement section last year, compared to 1.1 million units in 2015. The illegal products included sedatives (40 per cent), anabolic steroids (16 per cent) and erectile dysfunction medicines (14 per cent). In these figures, there was a significant increase in the number of anabolic steroids detained (109,006) compared to 2015 (38,049). Six prosecution cases were initiated and 13 voluntary formal cautions were issued during the year.

However, the HPRA welcomed the decrease year-on-year in the total number of products detained. “In general, I think we would never relax about the area of illegal sales of medicine or illegal supply of medicines coming into Ireland and it is an area that we will always continue to be vigilant on,” Ms Nolan tells MI. She says it is an area where partnerships have contributed to success. “So we don’t work alone; we work in partnership with An Garda Síochána and the Revenue and Customs Service. “That being said, if you look at the statistics for the 2016 dosage units in total, I think that we are seizing 1,800 dosage units of illegal medicines a day; by anyone’s consideration, that is worrying. I think continuing our work in this area is going to be a very important focus of ours.”

Cannabis

The HPRA was also in the news with the publication of its report Cannabis for Medical Use — A Scientific Review earlier this year. The review concluded that a cannabis access programme should be established to include access to cannabis-based therapies for the treatment of patients with spasticity associated with multiple sclerosis, intractable nausea and vomiting associated with chemotherapy and severe, refractory epilepsy.

However, the limited nature of this recommendation was criticised by some politicians and campaigners who sought a wider availability of cannabis for medicinal purposes. Following the publication of the report, questions were raised in the Dáil in March by Deputy Richard Boyd Barrett (Solidarity — People Before Profit) regarding the measures taken by the Department of Health “to prevent undue influence by the pharmaceutical industry on HPRA decisions on drug policy”.

In response, the Minister for Health Simon Harris said the HPRA fully complies with the Ethics in Public Office Acts, 1995 and 2011. He added that in 2016, 77 per cent of the Authority’s total income was obtained via regulatory fees charged to the pharmaceutical industry. “Competent authorities in other European countries and in other countries such as the USA, Canada and Australia also charge fees to pharmaceutical companies to reflect the costs associated with the regulation of medicines,” said Minister Harris in response. “Similarly, other Irish regulatory authorities also charge fees to the industries that they regulate.”

Ms Nolan underlines to MI that the report constituted an independent scientific review with no industry involvement. “We were asked by the Minister for Health in November last year to carry out a scientific review of cannabis and that was an entirely independent scientific review conducted without any involvement from the pharmaceutical industry at all,” Ms Nolan tells MI. “In conducting that review, we were assisted by a group of experts and those experts were scientists and clinicians who are working in the area of researching of cannabinoids. And we also included patient representation within that group, so there was absolutely no influence from industry in relation to that. The review focused on all the available published scientific evidence and literature in this area.”

Ms Nolan believes some of the discourse around medicinal cannabis does not reflect the reality. “The fact of the matter is, although it’s commonly said in media and other sources that there is very strong evidence to support the use of cannabis medically, when you actually come down and look at it, it’s not strong at all. In fact, it is often very conflicting,” says Ms Nolan. “The reality is, if we are talking about the medicinal use of cannabis, there is no reason why it should not be required to meet the same standards of safety and quality as every other medicine that is authorised and available in the marketplace.

“The medicines regulatory system exists to protect patients… we could not stand over a system of having a wide access to cannabis for medicinal use in Ireland based on where the evidence is currently at in relation to it.” Ms Nolan outlined the three areas in which the HPRA recommended some access and added “we also recommended this should be approached on the basis of a trial programme over a period of five years and that the information from that trial programme should be used and harnessed for further progress in medicinal use of cannabis, should it prove to have worked for those [areas]. Also, that the programme could be adjusted to take account of scientific progress in this area.

“But I absolutely reiterate that it was an entirely independent review that was carried out by the HPRA with no industry involvement, using clinical and scientific experts.”

Vaccines

The HPRA has also played a role in the recent public health push in defence of vaccines, in response to the fall in uptake of the HPV vaccine. The Authority has a unique position as both the regulator of vaccines and the organisation that monitors and registers any adverse effects reported from vaccine usage. “As an organisation, we absolutely support vaccination and we contribute in a number of ways to the development of vaccination policy and programmes to support vaccination,” says Ms Nolan.

“We obviously assess the safety, quality and efficacy of vaccines before their licence and use in Ireland. We also have a role in terms of monitoring the safety of vaccines once in use and promote the reporting of side-effects and contribute to the European and global safety monitoring in the collection of our data on the safety of vaccines. “We also approve the product information for both healthcare professionals and members of the public so they have the most up-to-date information possible.” Ms Nolan believes the HPRA will continue to play a role in supporting public confidence in the HPV vaccine. “I think particularly in relation to the issues around HPV, I think we really have stepped up. We publish a shortcut on the home page of our website which includes a list of all approved vaccines and their package leaflets and guidelines on the safety and appropriate use of the vaccine.

“We support Government vaccination policy and the work of the Department and the HSE and other national partners and we also sit as part of the National Immunisation Advisory Committee and contribute to its work in promoting effective evidence-based policies on vaccines and immunisation. “Clearly, if we authorise the use of a vaccine in Ireland, then we believe the product can make a positive contribution in terms of public health. We also know that vaccinations make a huge difference, not just nationally but globally in terms of reducing disease, disability and also death but it has [also] greatly reduced the burden of infectious diseases.”

Online

Ms Nolan says the Authority also undertakes an important public health and information task. “We are always really keen to point out to the public the danger of seeking medicines, particularly online,” says Ms Nolan, “because there is no guarantee of the quality and safety. Of course, I am talking about prescription-only medicine because new legislation did come in in 2015 which has a regulatory framework around supply of OTC medicines online.”

But does the HPRA have continued concerns over how the public interacts with medicine online? “Yes, it’s an area that we actively research; we carried out a number of cycles of market research in this area,” says Ms Nolan. “Our last cycle we carried out in November 2015. It is an area that we will go back and look at again. [The November 2015 research] indicates 2 per cent of the general public would have admitted to purchasing medicine online, which is 80,000 Irish adults. That figure, though, does remain pretty consistent with research we commissioned in 2012, which similarly indicated that figure at 2 per cent and also in 2010. “I do think, at least it’s staying consistent. It’s not rising. In terms of media campaigns that we are running in this area, they have been successful; they are certainly having an impact,” she concluded.


* Original Article published by the Medical Independent Ireland - medicalindependent.ie

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