Giuliana Miglierini

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EuropaBio’s data on international biomanufacturing

Politics & Business

14 March 2024

EuropaBio’s data on international biomanufacturing

Data presented by EuropaBio highlight the status of the biotech and biomanufacturing sector in relevant competitor countries (i.e. the US, China, India and Japan). The US has a higher number of biotech companies compared to Europe (8,000 vs 4,500), and a much greater access to funding (3,557 vs 1,558 companies receiving funding between 2015 and 2021). Targets to five years include the expansion of biomanufacturing capabilities to produce at least the 25% of APIs for small molecule drugs needed in the US. The improved economic prosperity and health consciousness of the Indian population is among the main factors driving the growth of the biotech and biomanufacturing sector in the country. India’s biotechnology industry estimated value was $63 billion in 2019, comprising more than 3500 biotech start-ups (approx. 5% of the global market).

Japan’s commitment with the bioeconomy is supported by the growing concern over environmental challenges, security of food supply, increases in lifestyle-related diseases and rising demand for pharmaceuticals. As for China, the increasing quality of scientific publications in the biotech field and a similar number of health-biotech patents as Europe in the period 2014-2020 are among signs of the strong commitment of the country to become a global powerhouse of high-tech, strategic industries.

Source: EuropaBio

UK, how the pharmaceutical industry can help HPs with complex prescribing decisions

Politics & Business

Giuliana Miglierini

29 February 2024

UK, how the pharmaceutical industry can help HPs with complex prescribing decisions

The new guide launched by the Association of the British Pharmaceutical Industry (ABPI) highlights the role the pharmaceutical industry plays in setting out the information aimed to provide high-quality healthcare and supporting clinicians dealing with challenging prescribing decisions.
According to the guide, resources from the pharmaceutical industry available to help guide appropriate prescribing include the Summary of Product Characteristics (SmPC), medical information and pharmacovigilance expertise, and medical advisers who can provide information and data as needed, including when it might be appropriate not to prescribe.
The report includes examples of the Medical Information Service (MIS) and the type of information provided to assist clinicians with their decisions in specific cases. MIS are provided in the UK by many pharma companies for healthcare professionals, patients and the public via telephone or email. MIS personnel are trained to provide balanced information and advice on all clinical aspects of medicines. The report also highlights the responsibilities of industry under the ABPI Code of Practice when interacting with healthcare professionals and organisations.

EMA’s recommendations on continuity of supply chains

European Union

Giuliana Miglierini

6 July 2023

EMA’s recommendations on continuity of supply chains

A new guidance has been published by the European Medicines Agency as part of its effort to prevent and mitigate medicines shortages. The document addresses the best practices the industry should follow in order to ensure continuity in the supply of human medicines. The ten recommendations are targeted to marketing authorisation holders, wholesalers, distributors and manufacturers.

Stakeholders are called to inform national competent authorities of potential or actual shortages as early as possible. Greater transparency as for the provided shortage information and the accuracy of notification detail is also requested to MAHs and other relevant stakeholders. Furthermore, each of them (in particular, MAHs, distributors and wholesalers) should establish a robust shortage prevention and management plan reflecting their respective roles. Optimisation of the pharmaceutical quality systems should represent another target for the industry, which should also take into due consideration known vulnerabilities in order to improve the resilience of complex, multinational supply chains.

A timely communication along the entire medicine supply chain, the respect of a fair and equitable distribution of medicines to meet the needs of patients, and the minimisation of the risk of parallel trade or export exacerbating shortages are other recommendations.