Responsability and Compliance

Business Ethics

Simply said, Business Ethics is about learning what is right and what is wrong, and then doing the right thing. Now, Philosophers have been discussing ethics for the last 2500 years, and this is still going on. Ethics in the Business environment will not only mean abiding to laws and regulations,  but also developing  codes of conduct, business principles and policies and procedures that anticipate stakeholders and societal expectations.
An ethical conduct therefore is not the same as a legal conduct.
And the defining moments for behaving ethically is certainly when facing the situation of dealing with ethical dilemma in stressed situations.

The Complete Guide to Ethics Management (by Carter McNamara) provides more information and links to this topic. 

Aditionally, some warning signals, as described by the Markkula Center of Ethics should raise concerns about risks of crossing a line in ethical behavior, such as unrealistic target growth rates, on innovation drivers, on unexperience of core management, etc...

Responsible research and Innovation: The EU view

The ambition of the initiative of the European Commission on Responsible Research and Innovation (RRI) is to promote not only excellent but also socially desirable science and technology.

An overview of RRI is available in this document  archived on the RRI-Toolkit  webpage of the EU, that provides additional documents and Training Tools documents as well.While new and still work in progress, RRI is aiming at fostering 6 dimensions, that are:

- Ethics

- Gender Equality

- Governance

- Public Engagement

- Science Education

A thourough introduction to this topic of RRI  is provided by matterforall.org in this document

Responsable Investments

We have now evidence that companies that manage for the long term value cration perform substantially better than the others, because they have a better and broader management of risks, financial, environmental, societal and legal. They create sustainable value. More on this in this publication of the HBR!

The UN has sponsored the Principles for Responsable Investment (PRI), centered on environmental, social, and corporate governance (ESG), recognising that applying these Principles may better align investors with broader objectives of society. 

The implementation of PRI, and the ESG is gaining momentum but is still a work in progress. More has to be done on stadardisation of ESG reporting, transparency and making it part of the investment culture of large investors such as pension funds and governmental institutions. More on this in this McKinsey report

Investopedia is providing a review of principles of Responsable/Ethical  Investing: i.e. investments that make the world better, or at least not worse, for items such as environment and social responsability, human and workers rights, and corporate governance. And the taxonomy of Reposnible , Sustainable  or Impact Investment is clarified here.

Additionally, the UN Finance Initiative has published a Guideline summarizing the concepts of Responsible Investments.

Responsable Research?

Pressure is mounting to alter independency and quality of research. This may be due to the pressure to publish research that is not fully validated, or statistically clumsy, or to abide to pressure groups of all types. The Economist has described this pattern in an article: How Science goes wrong. And the EU has issued Guidelines on how research should be conducted with integrity.

Whatever the cause, there is a mounting danger that science and technology is getting perceived not as an objective and independant discipline that can be trusted, but reflecting pressures, and therefore more and more delivering questionable results. This is an issue that is raising concerns within the scientific community.
Various examples can be quoted here:
- from sheer dubious practices examplified by the research on health effect of sugar, as described by the New-York Times
- to the crisis of repeatability, especially in research in life scence, as elaborated in this article of the Economist: Trouble at the Lab.

This crisis of Reproducibility is developed by Nature in an article reflecting the concerns of a cohort of 1500 scientists.

In a time of accelerating changes, with challenges that can be only solved through innovative solutions, this may seriously endanger our ability to cope with necessary change, and therefore MUST be adressed (see also above, on RRI).

Social Responsibility

The UN Compact   is a framework that defines  ways of operating that, at a minimum, meet fundamental responsibilities in the areas of human rights, labour, environment and anti-corruption. This is the basis that many companies will use to define their corporate business principles.

A guideline for a stepwise implementation of the UN Compact is available here, providing a methodology to define acorporate specific strategy and action plan

Creating Shared Value

Creating Shared Value (CSV) was introduced by Michael Porter in his 2011 HBR article. It is summarized in this video . It is about connecting between societal and economic progress by developing corporate policies and practices that enhance the competitiveness of a company while simultaneously advancing social and economic conditions in which the company operates. In this view, it is not similar to Corporate Social Responsibility (CSR), which is more on complying to good practices at the workplace and for the environment, and at doing good through philanthropy. Both are important and relevant, but for Innovation, the CSV is better delineating what should be achieved. 

Implementing CSV means therefore:
- reconceiving products and markets
- redefining productivity in the value chain
- and enabling local cluster development

and is consequently business specific in the way it is done. Michael Porter, in this video, elaborates further on this, and how CSR differs from CSV. 

CSV is however still a debate, along the thinking of Milton Friedman, for who a company has a sole responsibility to maximize profit within a given framework of legislation, and without deception or fraud.

Information, desinformation, Myths, and Debunking them!

Misinformation can be seriously damaging, because at whatever level it is credited, people exposed to it will just stop believing in facts. Facts and "alternate facts" act as matter and anti-matter, and annihilate the truth. As remedy, or prevention, the concept of inoculation with disinformation was developed, but probably not without risks.  More on this in this article.

Controversies that are not based on authentic facts or science may generate a lot of friction losses, and hamper taking the proper decisions, at the corporate or society levels. 

When the science is not supporting your interests, there are well-known practices geared at generating doubts or confusion, in order to stop, or at least tangibly delay necessary actions to prevent harming societal interests. 

The "disinformation playbook" of the Society of Converned Scientists list a few of them, and the documentary "Merchants of Doubts" elaborates further on this, with several cases.

The Dekunking Myths Handbook is proposing a method to adress this situation: based on some results of cognitive science, the art of debunking is to focus on facts, and not the myths, at the risks of reinforcing beliefs, and not leave a cognitive vacuum in the mind of the persons to convince.

In the same spirit, and emulating immunology, faked information can be combated by 

Integrated Management systems

IMS = QMS + EMS + SMS + EnMS + FSMS + ISMS etc

AnIntegrated Management System (IMS) integrates all of an organization's systems and processes in to one complete framework, enabling an organization to work as a single unit with unified objectives. And it covers Management Systems (MS) such as:

- QMS: Quality (ISO-9001, ...)

- EMS: Environment (ISO 14001)

- SMS: Safety (OHSAS 18001)

- EnMS: Energy (ISO 50001)

- FSMS: Food Safety (ISO 22000)

- ISMS: Information Systems (ISO 27000)


Trends in Regulations for Life-Science and Medical Devices and Impact on Compliance

The foundational aim of any compliance program to regulations will always be simple: prevent, detect, respond to, and remediate risk. And as described here, the increasing complexity of regulation stemming from the accelerated use of such technologies as biomarkers, human genome mapping, mobile medical applications, cloud computing, and social media are having a profound effect not only on consumers but also on biopharmaceutical and medical device organizations and federal regulators. Waiting for certainty in the reguatory field is not an option anymore, and paying close attention to emerging regulatory developments and staying as flexible as possible is now a requirement for survival.

Some additional information and  guidance on regulations, are available at these links for  Food (example Europe), Environment, or Pharma

...

Innovation and Lean Regulation

The globalisation and complexification of the world poses new challenges to stability and shared prosperity. How will we come up with the new rules we need to make sure we continue to innovate and grow but also become a fairer, safer, and more inclusive global community? This is the topic of the book of Prof. G.K.Hadfield, reviewed here. Our regulation system is failing to address challenges such as poverty, instability, and oppression for the four billion living in poor and developing countries, largely outside of any formal legal framework. Our laws and regulations seem to be more and more inadequate for a fast changing world, but they also seem to get more and more an obstacle to innovation. A new paradigm is therefore needed., and the same type of innovative spirit we find in science and technology should be embraced in the legal disciplines.