Bayer — Rules as Code proof of concept

Overview

Bayer’s challenge

Bayer wanted to explore how the pesticide approval process could be streamlined without compromising the quality of decisions. Bayer was particularly interested in a simple use case like the regulatory application to add or change a manufacturer of a product. While these assessments are usually not complex, they often take a significant amount of time at the regulator level due to application backlog. As a result, approval processes can take up to 2 years or sometimes even longer. Currently, submissions are often handled via email, with producers sending completed forms and supporting attachments directly to the regulator.

The transformation

Salsa Digital built a Rules as Code proof of concept (PoC) that combines an online submission process with automated compliance review. The Rules as Code element establishes equivalence between both manufacturers based on the regulation. The digitisation component lets pesticide producers submit their application online. The regulators can review the submissions, sorted into two categories (Tier 1: equivalence is deterministically shown and; Tier 2: expert judgement is required to determine equivalence).

The outcomes

• A modern, digital interface pesticide producers can use to submit their application for review and approval online

• Instant feedback for pesticide producers on whether their submission meets the criteria for Tier 1 equivalence

• A demonstrator for Bayer to show European and United Kingdom regulators

• Automated compliance review using Rules as Code (OpenFisca)

• A backend submission interface so regulators can see submissions sorted into ‘Tier 1 equivalent’ or ‘Tier 2 review’

“We had the pleasure of working with Salsa on this project, and I can confidently say that the experience was great. From the beginning, they took the time to listen to our needs and fully understand our vision. Their ability to adapt to our requirements was impressive, ensuring that every request was addressed with care. Thanks to Salsa, the project went smoothly with a great result.”

Dr Tom Ruts
Regulatory Innovation Lead

Detailed case study

Below is detailed information on the challenge, transformation and final outcomes/benefits.

Bayer’s challenge — a lengthy submission and approval process

Bayer was keen to investigate how the pesticide regulatory approval process could be streamlined. The current systems for both European and UK operations involve the producers downloading complex Word document templates from the regulator website, compiling all the required information, and submitting the completed forms and supporting documentation to the regulator for review.

Even simple scenarios, including changes in the manufacturer or transitioning from pilot production to large-scale production, may be subject to regulatory delays of 18 months or more due to resource constraints.

This backlog of submissions made it difficult for Bayer and other developers to innovate and grow their businesses.

To test opportunities for streamlining regulatory processes, Bayer decided to investigate a Rules as Code prototype. Bayer wanted to focus on a guidance that sorted applications into Tier 1 and Tier 2 based on certain criteria. The rules are from the Guidance Document on the Assessment of the Equivalence of Technical Materials of Substances Regulated Under Regulation (EC) No 1107/2009, and the relevant legislation found in Annex IIA of Directive 91/414/EEC.

The transformation — digital submissions with automated compliance review

Salsa Digital started this Rules as Code engagement with a series of discovery sessions. These sessions focused on our standard RaC deliverables:

• Rules statements
• Visual diagram of the logic
• Spreadsheet with test cases, ready for our development team

The logic involved three ‘branches’ that reflected slightly different situations:

1. Technical material is coming from a new/different manufacturer
2. Change in the manufacturing process, and/or manufacturing location, and/or the addition of one or more alternative manufacturing locations
3. Moving from pilot production to large-scale production

Below is a screenshot of the visual logic diagram in Miro.

Scope review to include broader digitisation

As we progressed through our discovery sessions, the initial scope expanded. Instead of simply letting the producer know if their submission would be classified as Tier 1 and Tier 2, Bayer was keen to include a digital submission process. This addition was intended to serve as a demonstrator for regulators, illustrating how a (RaC) system could streamline regulatory workflows.

The digitisation submission element was scoped and designed, so that regulators can login to the backend of the website, see submissions sorted as Tier 1 or Tier 2, and then review the submissions. The idea is that Tier 1 submissions could be reviewed and approved by the administrative regulatory staff, while the in-demand experts (e.g. chemists) only need to review the more scientific, complex Tier 2 cases.

From the backend, regulators see all the submissions (as per below). They can see the company name, active substance name, submission type, registration number, and if the submission was marked as Tier 1 equivalent or for Tier 2 review.

Regulators can then review the full submission.

In a production situation (or expanded prototype) a workflow would be included so submissions could be assigned to different regulator staff members and eventually approved or declined all through the one backend system.

Another next step would be to build a database of active substances and impurities, so some of the chemical information could be auto-populated.

OpenFisca and Drupal

This engagement combined OpenFisca* with a Drupal** content management system to showcase a modern approach to regulatory compliance.

The rules are programmed into OpenFisca for a deterministic Tier 1 equivalence=True or False (where False = Tier 2 review required).

In this prototype, Drupal is actually doing some of the calculation logic, while also drawing on its content management and workflow system to provide a digitised version of the regulatory process.

*OpenFisca is an open-source Rules-as-Code engine designed to translate legislation, regulations, and policy rules into executable code.

**Drupal is an open-source platform for building and managing websites and digital experiences.

A custom presentation

Salsa Digital also worked with Bayer to create a presentation for pesticide regulators and other potential stakeholders. The presentation outlines what Rules as Code is, the benefits of RaC, who’s using RaC, RaC in agriculture (where to start, making the switch and the prototype demo), and next steps.

The outcomes — a Rules as Code prototype

• A demonstrator for Bayer to show European and United Kingdom regulators, which was also shared with regulators in North and South America
• A modernised, digital interface so pesticide producers can submit their substances for review and approval online
• Instant feedback for pesticide producers, confirming at submission whether their material meets the criteria for Tier 1 equivalence
• Automated compliance review using Rules as Code (OpenFisca) to see if the substance meets Tier 1 requirements (saving significant time and resources for regulators) without compromising the quality of decisions
• A backend submission interface so regulators can see submissions sorted into ‘Tier 1 equivalent’ or ‘Tier 2 review’
• A presentation to show regulators and other pesticide producers how Rules as Code would transform pesticide regulation

Bayer was so satisfied with the outcomes of the prototype, that they asked Salsa to deliver a similar proof of concept based on the Canadian regulations.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of healthcare and agriculture. Bayer's mission is straightforward: “Health for all, Hunger for none”. As a global leader in health and nutrition, Bayer is committed to tackling the pressing challenges of our time, including a growing and ageing population and the strain on our planet's ecosystems.