June Shannon looks at the impact generic substation has had in Ireland over the past four years.
A 2008 study in the Irish Medical Journal revealed that in the previous year spending on medicines under the Community Drugs Schemes in Ireland exceeded €1.74 billion, a five-fold increase over the decade 1997-2007. It also found that the year-on-year increase in spending on medicines was amongst the highest in Europe. (Ir Med J. 2008 Nov-Dec; 101 (10):299-302).
In an effort to stem Ireland’s ever-increasing drugs bill, the Health (Pricing and Supply of Medical Goods) Act 2013 was enacted in May 2013, which allowed for the introduction of generic substitution and reference pricing for the first time.
The new legislation allowed pharmacists to substitute a prescribed branded medicine for a cheaper generic one that had been deemed interchangeable by the Health Products Regulatory Authority (HPRA). Prior to this, pharmacists could only dispense exactly what was on the prescription.
Under the Act, the HPRA is required to establish, publish and maintain a ‘list of interchangeable medicines’ (IC list). Medicines that are considered interchangeable are grouped together according to their active substance, strength (dose) and pharmaceutical form.
According to the HPRA: “[it] may of its own initiative or at the request of the Minister for Health or the HSE add a medicine or a group of medicines to the list of interchangeable medicines. As the purpose of the Act is to contain the costs of medicines, the Department of Health has requested the HPRA prioritise the review of the interchangeability of active substances contained in medicines that will achieve the greatest savings to the State and patients.”
The first list of inter-changeable medicines was published by the HPRA in August 2013 and included 96 atorvastatin products within four separate groups.
Since then the HPRA has been continually adding to and updating the list, and today it contains more than 70 active substances, from aledronic acid to zoplicone, and omeprazole and pantoprazole in between.
A 2014 study by researchers at the University of Limerick (UL) found that 31 per cent of patients had no knowledge of generic medicines and 39 per cent of those exhibited confusion between the words ‘generic’ and ‘genetic’.
The study, which was carried out to assess how generic medicines were perceived among patients in the time leading up to the enactment of the new legislation, was published in the journal The Patient — Patient-Centered Outcomes Research. (The Patient — Patient-Centered Outcomes Research, June 2014, Volume 7, Issue 2, pp 177–185). It found that 24 per cent of patients surveyed viewed generics as poorer quality than originators, and 18 per cent thought they didn’t work as well.
Lead researcher Dr Suzanne Dunne explained the significance of the research: “The study has shown that Irish patients’ understanding of what generic medicines [are] may have been overestimated in previous reports. Simple ‘Do you know what a generic medicine is’-type surveys do not capture the potential misunderstanding or confusion caused by the term. For instance, we determined that some patients confuse the work ‘generic’ with ‘genetic’. Such misinterpretation can only be detected by spending more time with patients than is usual in brief vox pop surveys.”
The study also revealed the high level of trust patients had in their GPs, with 90 per cent of patients stating that they would take a generic if prescribed by their GP.
Furthermore, a majority of patients (86%) were in favour of reference pricing and generic substitution. Of the patients interviewed, half stated that a leaflet, or similar, with appropriate, understandable, and accessible information regarding generic medicines would be of use to them.
So four years on from the introduction of generic substitution in Ireland, how are we doing?
The community pharmacist has a key role in educating patients about generic medicines, and they were central to reassuring patients that although the generic may have looked different, the brands were the exact same as their branded medications.
Caitriona O’Riordan is a community pharmacist in Enniskeane, Co Cork, and member of the Executive of the Irish Pharmacy Union (IPU).
She told IMT that despite some challenges at the initial phase of introduction, particularly with older patients, generic substitution was now going well.
“It was a big leap for everybody at the beginning, both from our point of view and definitely for patients,” O’Riordan said.
While the community pharmacist found that some younger patients were “early adopters” and actively requested generic substitution, it did pose some difficulty for older patients.
However, thanks to the effort of the HSE and the IPU, who provided excellent patient information leaflets, and committed pharmacists on the ground like O’Riordan who spent time with older patients to reassure them, four years on it seems generic substitution has been well accepted by patients and healthcare professionals alike.
“I think it is going well. It is positive that people have choice, and certainly I know the price of the branded drugs have come down, but the generics can still beat them on price,” O’Riordan stated.
The pharmaceutical industry in Ireland comprises a mix of international and local companies. Approximately 120 overseas firms have plants in Ireland, including nine of the 10 largest pharmaceutical companies in the world.
A number of the leading generic manufacturers are Irish companies, and, interestingly, O’Riordan said that this was seen by some patients as an added bonus, as buying generic medicines meant that you were also buying Irish and supporting the local economy.
A report from the OECD, which was published in January this year, found that the market penetration of generics ranged between 10 and 80 per cent across OECD countries.
The report ‘Tackling Wasteful Spending on Health,’ which reviews strategies put in place by countries to limit ineffective spending and waste, stated that “the use of generic drugs is a good opportunity to free up resources within health care systems”.
However, the report found that some countries did not fully exploit the potential savings offered by generic drugs and Ireland came 16th out of a list of 23 countries in terms of generic market share by volume.
The report also found that in parallel with generic drug competition, countries could realise “significant savings” by opening the market to biosimilar competition.
Speaking at an event last month on medicine spending, the Minister for Health Simon Harris said there was now “a real opportunity” for Ireland to make significant savings by adopting and increasing the usage of biosimilars. “The estimated spend in Ireland on six biologic drugs that are due to lose exclusivity over the next two-to-three years was approximately €170m in 2015.”
Minister Harris went on to say that biosimilar medicines could be significantly cheaper than biologic medicines.
“However, far greater discounts on certain products are achievable. As more and more biosimilars are launched they will have a significant impact on the sustainability of health systems across the world,” he added.
According to Minster Harris, the 2016 IPHA agreement on the pricing and supply of medicines provides for a 30 per cent reduction on the price of a biologic medicine when a biosimilar is launched in Ireland. The potential saving using this figure alone and based on 2015 spending is over €50 million per annum, he explained.
The Minister also said that he wished to see real price competition with existing biologics. “As a system we must be able to capitalise on this so that we can reduce the overall cost of medicines to the State and for patients. We have seen the positive impact that generics have had on the affordability of medicines.”
According to a 2015 report from the Joint Oireachtas Health Committee on the cost of prescription drugs in Ireland, generic penetration has “increased significantly in recent years, with the share of generics reaching nearly 70 per cent in some cases under the GMS scheme”.
Generic penetration of the market in Ireland started from a very low base of less than 10 per cent before the 2013 legislation to an estimated 55 per cent today.
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