Dataset Information

Off-Patent Biologicals and Biosimilars Tendering in Europe-A Proposal towards More Sustainable Practices.

ABSTRACT:

Background

In Europe, off-patent biologicals and biosimilars are largely procured by means of tender procedures. The organization and design of tenders may play a key role in the evolving biosimilar market, and currently, it is not fully elucidated how tenders for off-patent biologicals and biosimilars are designed and if approaches are aligned with sustaining market competition and societal savings for healthcare systems over the long term. This study aims to (i) explore the design and implementation of tender procedures for off-patent biologicals and biosimilars in Europe, (ii) identify learnings for sustainable tender approaches from purchasers and suppliers, and (iii) formulate recommendations in support of competitive and sustainable tender practices in the off-patent biologicals market.

Methods

A mixed methods design was applied. A quantitative web-survey was conducted with hospital pharmacists and purchasers (N = 60, of which 47 completed the survey in full), and qualitative expert-interviews with purchasers and suppliers (N = 28) were carried out.

Results

The web survey results showed that the organization and design of tenders for off-patent biologicals and biosimilars, and the experience of hospital pharmacists and purchasers with this, considerably varies on several elements across European countries. From the qualitative interviews, signals emerged across the board that some of the current tender approaches might negatively affect market dynamics for off-patent biologicals and biosimilars. The focus on generating short-term savings and existence of originator favouring tender practices were identified as elements that may limit timely competition from and market opportunity for biosimilar suppliers. The need to optimize tender processes, considering a more long-term strategic and sustainable view, was expressed. In addition, challenges appear to exist with differentiating between products beyond price, showing the need and opportunity to guide stakeholders with the (appropriate) inclusion of award criteria beyond price. Due to the variety in tender organization in Europe, a 'one size fits all' tendering framework is not possible. However, on an overarching level, it was argued that tender procedures must aim to (i) ensure market plurality and (ii) include award criteria beyond price (warranted that criteria are objectively and transparently defined, scored and competitively rewarded). Depending on the market (maturity), additional actions may be needed.

Conclusions

Findings suggest the need to adjust tender procedures for off-patent biologicals and biosimilars, considering a more long-term strategic and market sustainable view. Five main avenues for optimization were identified: (i) safeguarding a transparent, equal opportunity setting for all suppliers with an appropriate use of award criteria; (ii) fostering a timely opening of tender procedures, ensuring on-set competition; (iii) ensuring and stimulating adherence to laws on public procurement; (iv) securing an efficient process, improving plannability and ensuring timely product supply and (v) safeguarding long-term sustainable competition by stimulating market plurality.

SUBMITTER: Barbier L

PROVIDER: S-EPMC8225063 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundClimate change is impacting the health of individuals worldwide. At the same time, the healthcare sector contributes to carbon emissions. In Australia, healthcare contributes 7% of the country's carbon footprint. Research into the environmental impact and mitigation of carbon emissions in primary care is an emerging area.ObjectiveTo explore staff perspectives on facilitators and barriers to environmental sustainability in 3 Australian general practices seeking to reduce their environmental impact.MethodsWe used a qualitative, case-study approach, conducting 23 semistructured interviews with staff across the 3 practices including nurses, administrative staff, and doctors. Observation of systems and staff behaviour relating to environmental sustainability was undertaken at 1 practice. Thematic analysis was conducted to determine themes relating to factors influencing the implementation of environmentally sustainable initiatives within practice settings.ResultsClimate mitigation efforts raised by participants were largely focussed on energy and waste reduction, rather than prescribing pharmaceuticals and staff and patient transport. Three main factors influencing change towards sustainable practice were identified: "Leadership," "Staff Engagement and Workplace Culture," and "Concomitant Benefits." A leadership team and workplace culture that valued environmental sustainability were found to be important facilitators, as were concomitant benefits, in particular financial savings. Barriers included what interviewees described as a lack of knowledge about initiatives with the highest impact, lack of understanding described by staff of the evidence behind particular initiatives, waning staff engagement and infection control concerns.ConclusionsOur research highlights several important factors that contribute to the implementation of intended environmentally sustainable initiatives in these 3 practices. Further education, research and high-level policy guidance on the potential environmental impact of prescribing pharmaceuticals, staff and patient transport and unnecessary tests and treatments are recommended to further promote environmental sustainability in primary care.