Standards and Regulations for the Bio‐based Industry STAR4BBI

This report describes possible solution directions to overcome market entry barriers due to regulation and standardisation that companies that are active in the bio‐based economy experience. The market entry barriers were investigated and described in the deliverable D2.1. Five main hurdles were described in D2.1:‐ A number of issues around End‐of‐Life of bio‐based products‐ Certification and standards‐ Biofuel policy, and the fact that supporting policy for bio‐based products is missing‐ Missing long term policy that helps to promote bio‐based products‐ Communication and image.In order to define possible solution routes to the hurdles, for each hurdle the relevant stakeholders and their drivers towards the hurdle were investigated. Based on this investigation directions for solutions were defined and discussed with various stakeholders. Furthermore a workshop was held where the solutions were presented and discussed with a broad group of stakeholders.Solution directions defined for the first four identified hurdles are:‐ End‐of‐Life issues: There is no general agreement on which EOL option is most preferable for a several bio‐based products. This relates to present regulations, recycling targets, and industrial operation practices and business models of waste processors. All parties involved would benefit from clear LCA data for EOL options for (groups of) products. This would allow governments, municipalities, consumers and waste processors to decide which product best goes where. Clear icons indicating the preferable EOL, EU wide can help to minimise products going into the “wrong” bin. And in particular cases it may be useful to indicate what is not the desired EOL route, e.g. for products which look like a particularmaterial but in fact are not. Furthermore research on recycling of bio‐based plastics and composting of biodegradable plastics is proposed with both the bio‐based plastics suppliers and the waste processors being stakeholders in the project.‐ Certification and standards: Several possible solutions are proposed to overcome the hurdle related to certification and standards. In principle, it is important to involve as many stakeholders as possible in the standardization process, in order to achieve a widely supported middle ground that corresponds as well as possible with everyday practice. Besides this, to give new materials the possibility to enter the market, standards should focus on the functioning of materials instead of the material itself. In the field of certificates, solutions lie in mutual compatibility, alignment and transparency in tests. However, aligning all involved parties can be (politically) challenging due to competition (between schemes). Moreover, amending standards is time consuming, but in the endthese proposed solutions could open the door more easily to new bio‐based materials. ‐ Biofuel policy: The RED puts pressure on availability and price of biomass for bio‐based products. Different options are considered as potential solutions. One option is to reform the RED in order to integrate bio‐based chemicals and materials. Another option is without changing the RED to create a link of bio‐based materials to the RED through a “bio‐ticket” system. The third option considered is a new directive special for bio‐based materials. Furthermore a harmonized classification system of wastes and residues across EU isnecessary, which needs to be implemented under the EU Waste Framework Directive (WFD). Where the use of feedstocks by the bio‐based products industry is possible, such Elimination of hurdles in standards and regulation uses must be incentivized. The same classification system that will be needed to bedeveloped by the WFD will need to be adopted by the Biofuel policy for defining the feedstocks of “advanced biofuels”.‐ Missing long term policy: In order to level the playing field between fossil‐based and biobased products two possible solutions are proposed. In the first place, the producer should be responsible for paying for the negative externalities of the production processes (e.g. possible damage to the environment) and not the whole society. Furthermore, sustainablecertifications, currently often asked only for bio‐based products, should be requested for all products. The lack of clear, robust methodologies and criteria for assessing the sustainability of both bio‐based and fossil‐based products represents a major gap that is hampering the future development of the bio‐based industry. Development of the same sustainability criteria for all types of feedstock (bio‐based and fossil based) and all sectors (materials and fuels/energy) across the whole life‐cycle (material production, use and EOL)is proposed as a potential solution. And harmonization of LCA procedures is described to be important for this. During the investigation process it was found that the fifth hurdle, communication and image, was an integral part of the other four hurdles, it was therefore not investigated and presented separately, but integral with the other hurdles. The solution directions described in this report are focused specifically on the hurdles that were collected in D2.1 by interviewing a number of companies. During the investigation also more general aspects to stimulate the introduction of bio‐based products came up. An overview of these is presented in appendix A.The analysis laid down in this report has served as the basis for a deeper investigation and proposals to overcome specific market barriers, which are presented in D4.4, and proposals for supporting policy, presented in D3.3

D4.4 Regulation action plan

The bioeconomy is a new market field that was not considered when most of the existing regula-tions were drafted in several areas, including, for example, regulations on the end-of-life (EOL) stage of plastics. Consequentially, even though an EU bioeconomy strategy exists, a coherent and coor-dinated policy framework is still missing1. In addition, the lack of necessary mechanisms (e.g. regu-lative carbon pricing) and the fact that existing policies and standards are mostly based only on fossil-based products (e.g. existing EOL schemes are focused on fossil-based products and do not consider bio-based counterparts) are hampering the development of the bioeconomy

Effectiveness, usability and acceptability of a smart inhaler programme in patients with asthma:protocol of the multicentre, pragmatic, open-label, cluster randomised controlled ACCEPTANCE trial

Introduction Suboptimal asthma control is associated with incorrect inhaler use and poor medication adherence, which could lead to unfavourable clinical and economic outcomes. Smart inhaler programmes using electronic monitoring devices (EMDs) could support self-management and increase medication adherence and asthma control. However, evidence on long-term benefits and acceptability is scarce. This study aims to investigate the effectiveness of a smart inhaler asthma self-management programme on medication adherence and clinical outcomes in adults with uncontrolled asthma, to evaluate its acceptability and to identify subgroups who would benefit most based on patient characteristics.Methods and analysis This open-label cluster randomised controlled trial of 12 months will be conducted in primary care in the Netherlands. General practices will be randomly assigned to either intervention or control group. We aim to include 242 patients. The intervention consists of (1) an EMD attached to the patient’s inhaler that measures medication use; (2) a smartphone application to set medication reminders, receive motivational messages and track asthma symptoms; and (3) a portal for healthcare professionals to view data on medication use. The control group is passively monitored by the EMD but cannot view their inhaler data or receive feedback. Eligible patients are adults with suboptimal controlled asthma (Asthma Control Questionnaire score ≥0.75) with evidence of non-adherence established by the EMD during a 6-week run-in period. Primary outcome is the difference in mean medication adherence between intervention and control group. Secondary outcomes include asthma control, asthma-related quality of life, exacerbations, acceptance, cost-effectiveness and whether the effect of the intervention on medication adherence and asthma control is modified by patient characteristics (eg, self-efficacy, medication beliefs and eHealth literacy).Trial registration numberNL7854

We provided patients with patients oriented diagnosis and treatment advice from their lung assessments using an algorithm. It was feasible and in general well appreciated by our patients

Aim: We examined the feasibility of automatically providing patients with their medical results from a lung function assessment . Method: 46 patients (20% male, mean age 61[20-86] years, 4 1 % asthma, 30% COPD) awere included. GPs were asked to discuss the results with their patients 3 weeks after assessment. An algorithm was developed to automatically generate the results according to 3 formats. Patients received these formats 3 weeks after assessment. We examined patients opinion's, preferences and disease severity with an evaluation questionnaire (rating scales 1(poor) to 10(excellent)), the Asthma Control Questionnaire(ACQ) and the Clinical COPD Questionnaire(CCQ) using non-parametric tests. Results: 33 patients returned the questionnaires. 97%(n=31) would like to view their results again. The information caused some patients to feel anxious (18% (n=6)) which might have been caused by the fact that 46%(n=15) of the patients were not informed about the results by their GP. Uncontrolled asthmatics (ACQ>1.5) were less likely to adhere to the provided advices (uncontrolled:n=5,mean 2.50, controlled:n=14,mean 3.00, MWU:p=0.02). Conclusion: Automatically providing results from lung function tests is feasible and well appreciated by patients. However, the results should first be discussed with the patient by a professional. (Figure presented)

Standards and Regulations for the Bio‐based Industry STAR4BBI

This report describes possible solution directions to overcome market entry barriers due to regulation and standardisation that companies that are active in the bio‐based economy experience. The market entry barriers were investigated and described in the deliverable D2.1. Five main hurdles were described in D2.1:‐ A number of issues around End‐of‐Life of bio‐based products‐ Certification and standards‐ Biofuel policy, and the fact that supporting policy for bio‐based products is missing‐ Missing long term policy that helps to promote bio‐based products‐ Communication and image.In order to define possible solution routes to the hurdles, for each hurdle the relevant stakeholders and their drivers towards the hurdle were investigated. Based on this investigation directions for solutions were defined and discussed with various stakeholders. Furthermore a workshop was held where the solutions were presented and discussed with a broad group of stakeholders.Solution directions defined for the first four identified hurdles are:‐ End‐of‐Life issues: There is no general agreement on which EOL option is most preferable for a several bio‐based products. This relates to present regulations, recycling targets, and industrial operation practices and business models of waste processors. All parties involved would benefit from clear LCA data for EOL options for (groups of) products. This would allow governments, municipalities, consumers and waste processors to decide which product best goes where. Clear icons indicating the preferable EOL, EU wide can help to minimise products going into the “wrong” bin. And in particular cases it may be useful to indicate what is not the desired EOL route, e.g. for products which look like a particularmaterial but in fact are not. Furthermore research on recycling of bio‐based plastics and composting of biodegradable plastics is proposed with both the bio‐based plastics suppliers and the waste processors being stakeholders in the project.‐ Certification and standards: Several possible solutions are proposed to overcome the hurdle related to certification and standards. In principle, it is important to involve as many stakeholders as possible in the standardization process, in order to achieve a widely supported middle ground that corresponds as well as possible with everyday practice. Besides this, to give new materials the possibility to enter the market, standards should focus on the functioning of materials instead of the material itself. In the field of certificates, solutions lie in mutual compatibility, alignment and transparency in tests. However, aligning all involved parties can be (politically) challenging due to competition (between schemes). Moreover, amending standards is time consuming, but in the endthese proposed solutions could open the door more easily to new bio‐based materials. ‐ Biofuel policy: The RED puts pressure on availability and price of biomass for bio‐based products. Different options are considered as potential solutions. One option is to reform the RED in order to integrate bio‐based chemicals and materials. Another option is without changing the RED to create a link of bio‐based materials to the RED through a “bio‐ticket” system. The third option considered is a new directive special for bio‐based materials. Furthermore a harmonized classification system of wastes and residues across EU isnecessary, which needs to be implemented under the EU Waste Framework Directive (WFD). Where the use of feedstocks by the bio‐based products industry is possible, such Elimination of hurdles in standards and regulation uses must be incentivized. The same classification system that will be needed to bedeveloped by the WFD will need to be adopted by the Biofuel policy for defining the feedstocks of “advanced biofuels”.‐ Missing long term policy: In order to level the playing field between fossil‐based and biobased products two possible solutions are proposed. In the first place, the producer should be responsible for paying for the negative externalities of the production processes (e.g. possible damage to the environment) and not the whole society. Furthermore, sustainablecertifications, currently often asked only for bio‐based products, should be requested for all products. The lack of clear, robust methodologies and criteria for assessing the sustainability of both bio‐based and fossil‐based products represents a major gap that is hampering the future development of the bio‐based industry. Development of the same sustainability criteria for all types of feedstock (bio‐based and fossil based) and all sectors (materials and fuels/energy) across the whole life‐cycle (material production, use and EOL)is proposed as a potential solution. And harmonization of LCA procedures is described to be important for this. During the investigation process it was found that the fifth hurdle, communication and image, was an integral part of the other four hurdles, it was therefore not investigated and presented separately, but integral with the other hurdles. The solution directions described in this report are focused specifically on the hurdles that were collected in D2.1 by interviewing a number of companies. During the investigation also more general aspects to stimulate the introduction of bio‐based products came up. An overview of these is presented in appendix A.The analysis laid down in this report has served as the basis for a deeper investigation and proposals to overcome specific market barriers, which are presented in D4.4, and proposals for supporting policy, presented in D3.3

D4.4 Regulation action plan

The bioeconomy is a new market field that was not considered when most of the existing regula-tions were drafted in several areas, including, for example, regulations on the end-of-life (EOL) stage of plastics. Consequentially, even though an EU bioeconomy strategy exists, a coherent and coor-dinated policy framework is still missing1. In addition, the lack of necessary mechanisms (e.g. regu-lative carbon pricing) and the fact that existing policies and standards are mostly based only on fossil-based products (e.g. existing EOL schemes are focused on fossil-based products and do not consider bio-based counterparts) are hampering the development of the bioeconomy

Effectiveness, usability and acceptability of a smart inhaler programme in patients with asthma: protocol of the multicentre, pragmatic, open-label, cluster randomised controlled ACCEPTANCE trial

Introduction Suboptimal asthma control is associated with incorrect inhaler use and poor medication adherence, which could lead to unfavourable clinical and economic outcomes. Smart inhaler programmes using electronic monitoring devices (EMDs) could support self-management and increase medication adherence and asthma control. However, evidence on long-term benefits and acceptability is scarce. This study aims to investigate the effectiveness of a smart inhaler asthma self-management programme on medication adherence and clinical outcomes in adults with uncontrolled asthma, to evaluate its acceptability and to identify subgroups who would benefit most based on patient characteristics. Methods and analysis This open-label cluster randomised controlled trial of 12 months will be conducted in primary care in the Netherlands. General practices will be randomly assigned to either intervention or control group. We aim to include 242 patients. The intervention consists of (1) an EMD attached to the patient's inhaler that measures medication use; (2) a smartphone application to set medication reminders, receive motivational messages and track asthma symptoms; and (3) a portal for healthcare professionals to view data on medication use. The control group is passively monitored by the EMD but cannot view their inhaler data or receive feedback. Eligible patients are adults with suboptimal controlled asthma (Asthma Control Questionnaire score ≥0.75) with evidence of non-adherence established by the EMD during a 6-week run-in period. Primary outcome is the difference in mean medication adherence between intervention and control group. Secondary outcomes include asthma control, asthma-related quality of life, exacerbations, acceptance, cost-effectiveness and whether the effect of the intervention on medication adherence and asthma control is modified by patient characteristics (eg, self-efficacy, medication beliefs and eHealth literacy). Trial registration number NL7854

Budesonide/formoterol maintenance and reliever therapy versus fluticasone/salmeterol fixed-dose treatment in patients with COPD

Background Maintenance and reliever therapy (MART) with inhaled corticosteroid (ICS)/formoterol effectively reduces exacerbations in asthma. We aimed to investigate its efficacy compared with fixed-dose fluticasone/salmeterol in chronic obstructive pulmonary disease (COPD). Methods Patients with COPD and ≥1 exacerbation in the previous 2 years were randomly assigned to open-label MART (Spiromax budesonide/formoterol 160/4.5 μg 2 inhalations twice daily+1 prn) or fixed-dose therapy (Diskus fluticasone propionate/salmeterol combination (FSC) 500/50 μg 1 inhalation twice daily+salbutamol 100 μg prn) for 1 year. The primary outcome was rate of moderate/severe exacerbations, defined by treatment with oral prednisolone and/or antibiotics. Results In total, 195 patients were randomised (MART Bud/Form n=103; fixed-dose FSC n=92). No significant difference was seen between MART and FSC therapy in exacerbation rates (1.32 vs 1.32 /year, respectively, rate ratio 1.05 (95% CI 0.79 to 1.39); p=0.741). No differences in lung function parameters or health status were observed. Total ICS dose was significantly lower with MART than FSC therapy (budesonide-equivalent 928 μg/day vs 1747 μg/day, respectively, p<0.05). Similar proportions of patients reported adverse events (MART Bud/Form: 73% vs fixed-dose FSC: 68%, p=0.408) and pneumonias (MART: 5% vs FSC: 1%, p=0.216). Conclusions This first study of MART in COPD found that budesonide/formoterol MART might be similarly effective to fluticasone/salmeterol fixed-dose therapy in moderate to severe patients with COPD, at a lower daily ICS dosage. Further evidence is needed about long-term safety