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1 Headline Verdana Bold Proposal for a study report on Belgium as clinical trial location in Europe Belgium as clinical trial location in Europe Presentation of results for May 2018

2 Methodology of the study Objective of the study: to benchmark Belgium as a clinical trial location against other EU countries Ten EU Countries were included in the study: Belgium, Estonia, Denmark, France, Germany, the Netherlands, Poland, Spain, Sweden and the United Kingdom Sweden Data sources: Denmark Data on clinical trial authorisations in Belgium for the year 2016, provided by the Federal Agency for Medicines and Health Products (FAMHP) Data from the EU Clinical Trials Register for clinical trial authorisations between 31/12/2014 and 1/8/2017 Annual reports of the national medicines agencies Data on R&D expenditure and population data obtained from Eurostat Web survey conducted amongst the members of pharma.be In-depth interviews with industry experts, academics, and the FAMHP Data validation: the results of the study were validated against annual reports of national authorities and data of the FAMHP. The results of the study were regularly discussed with the pharma.be project team and were also presented to the pharma.be clinical trial task force and clinical trial work group in order to obtain additional insights. Netherlands United Kingdom France Estonia Poland Limitations of the study: Comparison was based on data from the EU Clinical Trials Register: Country-specific reporting may vary considerably, impacting comparison of national medicines agency data across countries Spain Belgium Germany 2018 Monitor Deloitte Draft report Belgium as clinical trial location in Europe v2.0 2

3 Descriptive statistics trial characteristics 2018 Monitor Deloitte Draft report Belgium as clinical trial location in Europe v2.0 3

4 Clinical trials in Belgium Strong expertise in Phase I studies thanks to a favourable regulatory framework of the FAMHP 122 mononational clinical trials authorised by the FAMHP 360 multinational clinical trials authorised by the FAMHP Phase I Phase II Phase III Phase IV Phase I Phase II Phase III Phase IV 98 single site 24 multiple sites Source: FAMHP 2018 Monitor Deloitte Draft report Belgium as clinical trial location in Europe v2.0 4

5 Clinical trials in Belgium A wide variety of therapeutic areas, with strong expertise in cancer research Top 5 therapeutic areas in Belgium Cancer 28,1% (n=142) Other 46,2% (n=234) Nervous system diseases 8,9% (n=45) Digestive system diseases 5,7% (n=29) Respiratory tract diseases 5,5% (n=28) Immune system diseases 5,5% (n=28) Source: FAMHP. The therapeutic areas are mutually exclusive. Cancer [C04]; Nervous system [C10]; Digestive system [C06]; Immune system [C20]; Respiratory tract [C08] Monitor Deloitte Draft report Belgium as clinical trial location in Europe v2.0 5

6 Clinical trials in Belgium More than two out of five clinical trial authorisations include biological products Clinical trial authorisations by type of investigational medical product, as proportion of total Chemical origin Biological origin ATIMP Combination product including device Radiopharmaceutical gene therapy medical product 4 somatic cell therapy medical product 1 tissue engineered Immunological 32 Plasma derived 1 Extractive MP 3 Recombinant 142 GMO 6 Herbal + Homeopatic 3 Extractive MP = a medicinal product derived from human tissue such as blood or plasma. Source: FAMHP. Categories are not mutually exclusive Monitor Deloitte Draft report Belgium as clinical trial location in Europe v2.0 6

7 Clinical trials in Belgium Belgium demonstrates continued leadership in the number of clinical trials per capita in the EU Evolution of clinical trial applications per 1 million capita between in cohort countries Estonia Denmark Belgium Sweden Netherlands Spain UK Germany France Poland Belgium, together with Estonia and Denmark, is consistently part of the top 3 countries in terms of number of clinical trial applications per 1 million capita. Although it has the lowest absolute number of clinical trial applications, Estonia has the highest number of clinical trial applications per capita due to its very small population of 1.3 million people. Based on this chart, 3 main groups can be distinguished: Countries with a high number of clinical trial applications per capita: Estonia, Denmark, Belgium Countries with a medium number of clinical trial applications per capita: Sweden, Netherlands Countries with a low number of clinical trial applications per capita: Spain, the United Kingdom, France, and Poland In 2017, clinical trial applications per 1 million capita in Belgium was 47,63 Source: Eurostat (2017); Annual report NMAs; FAMHP 2018 Monitor Deloitte Draft report Belgium as clinical trial location in Europe v2.0 7

8 Clinical trials in Belgium A relatively high percentage of clinical trials in Europe are conducted in Belgium Percentage of clinical trials in Europe conducted in Belgium Total population of Belgium relative to the total population of the European Union in ,5% 15,8% 11 million Total population in Belgium Cancer 16,7% Nervous system 14,2% 510 million Total population in the European Union Source: FAMHP; Eurostat 2016 Immune system Paediatric studies 2018 Monitor Deloitte Draft report Belgium as clinical trial location in Europe v2.0 8

9 Belgium n=201 Denmark n=255 Estonia n=48 France n=180 Germany n=611 Netherlands n=398 Poland n=271 Spain n=626 Sweden n=179 UK n=514 Clinical trial characteristics The proportion of clinical trials for rare disease in Belgium is comparable to other countries in scope Percentage of clinical trial applications aggregated over all phases (I-IV) for rare diseases per country 30% 25% 20% 22% 20% 21% 23% 25% 20% 22% 18% 25% The United Kingdom and the Netherlands have the highest proportion of clinical trial applications for rare diseases. The number of clinical trial applications for rare diseases is stable across the cohort countries apart from Estonia, a country with a very small population. 15% The number of clinical trial applications for rare diseases is not higher in countries with a large population such as Germany, France or Spain. 10% 5% 4% 0% Source: Monitor Deloitte analyses based on EU Clinical Trials Register data 2018 Monitor Deloitte Draft report Belgium as clinical trial location in Europe v2.0 9

10 Belgium n=201 Denmark n=255 Estonia n=48 France n=180 Germany n=611 Netherlands n=398 Poland n=271 Spain n=626 Sweden n=179 UK n=514 Clinical trial characteristics Belgium, together with Estonia, are leaders in conducting paediatric clinical trials Percentage of clinical trial applications aggregated over all phases (I-IV) for clinical trials that are part of a paediatric investigation plan 14% 12% 13% Estonia and Belgium have a larger proportion of clinical trial applications that are part of a paediatric investigation plan compared to the other cohort countries. 10% 9% This may be linked to the fact that paediatric oncology is one of the strategic focus areas of the FAHMP. 8% 7% 6% 4% 5% 3% 4% 6% 6% 3% 5% 2% 0% Source: Monitor Deloitte analyses based on EU Clinical Trials Register data 2018 Monitor Deloitte Draft report Belgium as clinical trial location in Europe v2.0 10

11 Patient involvement 2018 Monitor Deloitte Draft report Belgium as clinical trial location in Europe v2.0 11

12 Patient involvement in Belgium A larger proportion of multiple sites facilitates patient access to clinical trials Clinical trial authorisations on single vs multiple sites Average planned number of patients and healthy volunteers recruited per phase (I-IV) across all sites 55 35,8% 59,5% Single site (n=181) Multiple sites (n=301) Phase I Phase II Phase III Phase IV Source: Monitor Deloitte analysis based on FAMHP data 2018 Monitor Deloitte Draft report Belgium as clinical trial location in Europe v2.0 12

13 Patient involvement in Belgium A large diversity in recruited patients and healthy volunteers Number of clinical trial authorisations in 2016 planning recruitment of specific population groups Under 18 years Adults (18-64 years) in utero 0 preterm new-born infants 2 newborns (0 27 days) 18 infants and toddlers (28 days 23 months) 46 children (2 11 years) 48 adolescents (12 17 years) Elderly (over 65 years) 312 Healthy volunteers 81 Patients 399 Source: Monitor Deloitte analysis based on FAMHP data 2018 Monitor Deloitte Draft report Belgium as clinical trial location in Europe v2.0 13

14 Economic impact 2018 Monitor Deloitte Draft report Belgium as clinical trial location in Europe v2.0 14

15 Economic impact Business enterprises in Belgium invest most in pharmaceutical R&D per capita within the country cohort Business R&D expenditure for manufacture of basic pharmaceutical products and pharmaceutical preparations by country in 2013, expressed in purchasing power standard per inhabitant at constant 2005 prices Belgium has the highest business R&D expenditure expressed in purchasing power standard per inhabitant at constant 2005 prices, closely followed by Denmark. Other countries follow at a large distance The purchasing power standard is an artificial currency unit. One purchasing power standard can buy the same amount of goods and services in each country. However, price differences across borders mean that different amounts of national currency units are needed for the same goods and services depending on the country. Purchasing power standards are derived by dividing any economic aggregate of a country in national currency by its respective purchasing power parity. The purchasing power standard is the technical term used by Eurostat for the common currency in which national accounts aggregates are expressed when adjusted for price level differences using purchasing power parities. Thus, purchasing power parities can be interpreted as the exchange rate of the purchasing power parities against the euro. Source: Eurostat (2017). R&D expenditure: business R&D expenditure (BERD) by economic activity (NACE Rev. 2 Manufacture of basic pharmaceutical products and pharmaceutical preparations); Eurostat (2017). Statistics explained: glossary Monitor Deloitte Draft report Belgium as clinical trial location in Europe v2.0 15

16 Economic impact Belgium has the second highest R&D employment per capita in the pharmaceutical industry within the country cohort R&D employment in business enterprise: Manufacture of basic pharmaceutical products and pharmaceutical preparations in FTE per capita, per million, by country in Total R&D employment expressed in FTEs in Belgium in the biopharmaceutical industry is 4330, of which an estimated 60% is related to clinical trials. The Belgian R&D employment per 1M capita in the biopharmaceutical industry is Belgium has the second highest R&D employment when expressed as FTE per 1M capita and the 5 th highest R&D employment expressed in FTE of the cohort countries, ranked after Germany (18767 FTEs), Denmark (6071 FTEs), France (5261 FTEs) and Spain (4449 FTEs). At the FAMHP, 17.6 FTEs were directly employed in the area of clinical trials in Source: Eurostat (2017). Total R&D personnel and researchers, in business enterprise sector by economic activity and sex (NACE Rev. 2); web survey pharma.be members; FAMHP 2018 Monitor Deloitte Draft report Belgium as clinical trial location in Europe v2.0 16

17 Attractiveness of Belgium 2018 Monitor Deloitte Draft report Belgium as clinical trial location in Europe v2.0 17

18 SWOT analysis by Deloitte Overview of the strengths, weaknesses, opportunities and threats for Belgium as a clinical trial location in Europe Strengths Weaknesses Opportunities Threats Accessibility of clinical expertise Pragmatic and flexible medicines agency with pronounced expertise in strategic areas Research-minded environment Post-trial access through Early Temporary Authorisation (ETA) Patient recruitment and retention Policy making needs to keep pace with scientific developments and technological trends Healthcare reform and hospital networks Momentum of European Clinical Trial Regulation Recruitment of European Medicines Agency experts by the FAHMP after Brexit Digitalisation Competitors on the horizon Readiness for the new European regulation Uncertainty around potential impact of Brexit Source: Monitor Deloitte analysis based on primary research 2018 Monitor Deloitte Draft report Belgium as clinical trial location in Europe v2.0 18

19 The use of digital technology to support clinical trials Belgium has employed various technologies to increase the efficiency of clinical trial recruitment and management Biopharmaceutical companies that have used any type of digital technology to support clinical trials in Belgium Type of technologies used Medical-grade devices (67%) Objectives Increase accuracy of data collection 67% Mobile apps (33%) Social media (33%) Tablet for PRO questionnaire (33%) Wearables (33%) Increase speed of accessibility to source data Increase regulatory compliance (e.g. use of adequate informed consent forms Increase patient recruitment Bar code scanner (8%) Provide easily accessible information to investigators and site personnel Source: Monitor Deloitte analysis based on primary research Improve patient adherence and persistence 2018 Monitor Deloitte Draft report Belgium as clinical trial location in Europe v2.0 19

20 Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee ( DTTL ), its network of member firms, and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as Deloitte Global ) does not provide services to clients. Please see for a more detailed description of DTTL and its member firms. Deloitte provides audit, tax, consulting, and financial advisory services to public and private clients spanning multiple industries. With a globally connected network of member firms in more than 150 countries and territories, Deloitte brings world-class capabilities and high-quality service to clients, delivering the insights they need to address their most complex business challenges. Deloitte s more than 200,000 professionals are committed to becoming the standard of excellence. This communication contains general information only, and none of Deloitte Touche Tohmatsu Limited, its member firms, or their related entities (collectively, the Deloitte Network ) is, by means of this communication, rendering professional advice or services. No entity in the Deloitte network shall be responsible for any loss whatsoever sustained by any person who relies on this communication For information, contact Deloitte Belgium