Sustainability a focus of new strategy for Irish generic medicines sector

Sustainability has been highlighted as one of the three core strategic ‘pillars’ of MFI’s 2024-2029 vision (17-page PDF/6.1MB) alongside drug affordability, and accessibility and supply chain resilience. The Irish body has called for the country’s generics, biosimilars and value-added medicines industry to embed sustainability in its operations, but do so through a “balanced approach” that doesn’t overshadow public health benefits, such as availability of medicines. 

According to MFI, it supports the Irish Health Services Executive’s (HSE) Climate Action Strategy that aims to provide healthcare that is environmentally and socially sustainable, but acknowledges that sustainability decisions and exercises “can have ramifications for the supply of medicines to patients,” which especially affects generics and biosimilar developers as they operate on low-cost models and face increasing supply chain costs.

“While we acknowledge there is an environmental impact of our industry, we strongly advise against altering the risk-benefit principle for pharmaceuticals and emphasise the need for careful consideration to maintain the balance between environmental protection and patient care,” MFI said in its strategy.

The industry association identified digital communications as an important area where pharma manufacturers can reduce financial and environmental costs. MFI has said it will work with relevant stakeholders to find ways to increase the use of digital communications to fulfil certain manufacturer requirements, including providing direct healthcare professional communications (DHPCs) and ‘caution in use’ (CIU) notifications, as an alternative to hard copy. Accelerated adoption of electronic patient information leaflets is another way to help strike the balance of reducing environmental impact and efficiently distributing products.

Pinsent Masons life sciences expert Karen Gallagher said that it was no surprise to see sustainability featuring in 2 of the 3 key pillars highlighted by MFI in its vision strategy, given that one of the aims of the European Commission in its proposed pharmaceutical reforms is to make medicines more environmentally sustainable.

“There is no doubt that an initiative such as increased use of digital communications to healthcare professionals would have an effect not only on environmental impact, but the speed with which generics and biosimilars products can get to market – feeding into the patient access pillar of the vision strategy,” she said.  

In addition to embedding sustainability within the industry, MFI has also emphasised the importance of fostering a market ecosystem that promotes fair competition and availability of medicines, which is “pivotal” in achieving the two other strategic goals - enhancing patient access and affordability and securing a sustainable supply chain. The industry body said that several factors – including reduced price entry point, downward-only pricing structures, and lengthy timelines for price uplifts for unviable products – are affecting generic medicine market penetration in Ireland, as well as market attractiveness. Although the usage of generic medicines has increased significantly in Ireland, up from 32% of all prescribed medicines in 2011 to 58% in 2023, Ireland still lags behind its European counterparts, including the UK, Germany and the Netherlands.

Gallagher said: “In recent years, the HSE has been grappling with how best to make use of resources available to fund the national medicines bill. Professor Michael Barry, Clinical Director of the National Centre for Pharmacoeconomics (NCPE), has previously called for an increase in use of and investment in generics and biosimilars in Ireland. The argument is that increased use of generics leaves more budget available to fund investment in new drugs. The MFI vision strategy document acknowledges this issue and sets out specific proposals for pricing reform to try to address it.”

The industry association plans to deliver a supply and pricing framework agreement that “introduces resilient and forward-thinking strategies that counteract escalating inflation and effectively address the evolving challenges within the market landscape,” such as tiered pricing, de-linkage from originator price models, and automatic indexation models.

For biosimilars, given that these medicines face low uptake, lack of incentives, and regulatory uncertainty, MFI suggests that incentives should be introduced to use multiple biologic medicines in a best-value biologic process to help avoid monopoly supply.

To advance the role of ‘value-added’, repurposed medicines, MFI proposes to introduce a specific reimbursement process for these medicines, and to influence policies that promote fair competition, value for the country, and streamlined approval processes.

Under MFI’s vision, pharma manufacturers could expect some changes in Ireland’s pharmaceutical supply chain regime to help address the challenges they face operating in a global market.   

The organisation said it would encourage the HSE “to adopt a more flexible and responsive approach to the pricing and procurement of medicines”, and that it would “foster constructive dialogue and collaboration between the HSE and manufacturers to ensure that Ireland remains an attractive and viable market for them”.

While the European Commission is in the process of amending the Pharmaceutical Directive and Regulation, MFI has suggested several changes to ensure “consistent outcomes and provide legal clarity to harness the benefits of off-patent medicines fully”. They include providing legal certainty for generic and biosimilar medicines modulating incentives based on public health objectives; removing barriers to entry for off-patent medicines by clarifying the ‘Bolar’ exemption defence in patent infringement and facilitating administrative processes; and adopting solidarity-based market models to reward innovation and ensure a secure supply of reserve antibiotics.

The full impact of this strategy plan will be reviewed in October 2029, but MFI said it will maintain a “flexible and agile approach” that will allow it to “adapt quickly to changing circumstances and seize opportunities as they arise”.