Good morning and thank you for inviting me to speak to you today. Let me say at the outset that I acknowledge the challenges your industries face in relation to ethics and compliance. I also acknowledge the genius of the scientists and others you work with and the complexity involved in navigating your way through sensitive regulatory issues.

Medical technology and pharmaceutical industries are not just highly regulated but the ethical and compliance decisions that you make are self-evidently consequential for the health outcomes and life chances of billions of people across the globe.

Consequential too are the ways in which your industries attempt to influence the development of regulations that you may subsequently have to comply with and it is in that general space of EU lobbying that my Office frequently acts.

In 2020, as COVID hit, the pharmaceutical industry held the world in the palm of its hand. We hid in our homes with fingers crossed and prayed for the miracles of science and the manufacturing and distribution genius of your industries to get us through.

It was, ultimately, a masterclass in the capacity and power of the pharmaceutical industry.

But COVID vaccines are just a tiny part of the story of how and what your produce and how and why you interact with governments and with regulators in and not every story of those manufacturing decisions and interactions is as clearcut as the COVID one.

This event is taking place in Brussels precisely because of the EU’s regulatory role and precisely because your industries – naturally and legitimately – want to exert influence on that regulatory process.

As Ombudsman, I am responsible for ensuring the EU institutions live up to the highest standards of good administration.

The primary role of any administration, any government, is to keep its citizens safe and, in regulating, whether pharmaceuticals, chemicals, food or anything else, the EU is seeking to do just that.

The tension arises when the regulatory intentions of the EU are met by industry concerns about the impact of those regulations on – essentially – their bottom line. And then the dance begins.

The critical issue is trust. If citizens trust that that their government has their interests at heart, they will by and large accept what it does and – such as COVID lockdown - do what it asks.

For your industries, citizens have to trust that a legitimate desire for profit does not compromise safety or equity.

Most people do not know how a new drug is approved, nor realise how health care professionals and hospitals may have been influenced to prescribe one company’s products over another’s.

Most are largely unaware of the enormous role of marketing in the pharmaceutical industry, believing perhaps, that drugs and medical devices exist in a different moral universe to that of smartphones, cars and handbags.

This lack of familiarity is understandable. The average person cannot scrutinise complex pieces of legislation nor follow a new medical product from development to pharmacy shelves. 

This is not to say that your goals and the public’s interest in a healthier society do not overlap. Most western governments see the sector as a crucial partner in delivering public health outcomes. To that end, they provide the funding for basic medical research and legal protections in the form of intellectual property rights which ensure the basic business model can work.

But private companies must nonetheless balance these interests with those of their shareholders, their employees, and others who depend on their survival as a going concern. In the long run, we hope and expect that these interests align.

In the shorter term, it is the role of those in compliance and ethics functions actively to manage the inherent conflicts of interest inherent in this system of – essentially -public-private partnerships. That implies of course that they are given the tools and the autonomy to do so.

But too often, we have seen the public interest/private profit interests catastrophically diverge.

In the last decade, for example, people in the United States have experienced an unprecedented rise in mortality and a decline in life-expectancy unique in the developed world. A large part of this increase is due to so-called ‘deaths of despair’, such as from alcohol and drug poisoning.

Much of the focus has been on the bribery and fraud perpetrated by one company, Perdue Pharma, for which it was successfully prosecuted by the US Department of Justice in 2020, receiving a record fine of over 3.5 billion dollars for a pharmaceutical company. 

However, overseeing the opioid crisis was the US Food and Drug Administration. In the Purdue case, the two principal FDA reviewers who originally approved Purdue’s oxycodone application – a fatal decision for tens of thousands of people – subsequently took up positions at Purdue.

Over the past 20 years, several other FDA staff involved in opioid approvals also left the FDA to work for opioid makers.

According to the American Medical Association’s Journal of Ethics: “The FDA has never been held to account for its improper handling of the opioid crisis, but the FDA’s conduct is all the more troubling in light of the close relationship between the agency officials responsible for opioid oversight and opioid manufacturers.”

The revolving door between the FDA and the pharmaceutical industry is not limited to opioids. A 2018 study found that 11 out of 16 FDA medical reviewers involved in approving 28 products now work for the companies whose products they regulated.

But while the FDA should rightly be criticised, the ethical responsibilities of the pharmaceutical industry cannot be ignored either.

In preparing for this morning, I came across company websites openly publicising their acquisition of former regulatory personnel, including from the FDA. The greater the insider knowledge, the greater the capacity to influence.

The Purdue case is just one example of how lax regulation of the “revolving door” between regulators and private companies can lead to devastating social harms. Similar cases also featured in the finance and banking sectors in the lead up to the financial crisis in 2008.

And the financial crash did not impact on people’s jobs or income alone; in my country as in many others people took their own lives out of despair, their families and communities devastated.  I never consider therefore that the phenomenon of revolving doors is ‘just the way the world works’.

Over the years, I have launched a number of inquiries into individual moves from EU institutions and agencies to the private sector. I found that the European Banking Authority – set up precisely to restore public trust in banking regulation - should not have permitted its former executive director from becoming the CEO of a major financial lobby association.

Similarly, I found that the European Defence Agency should not have allowed its former chief executive to become a strategic advisor at Airbus.

Revolving door hires are part of a broader strategy of shaping and influencing public policy, also known as lobbying. Lobbying is, of course, a fundamental part of a democratic society.

Nevertheless, there is a difference between lobbying as such and ethical lobbying, and this distinction goes beyond keeping one’s activities within the technical bounds of the law.

It includes a moral imperative to ask ourselves whether the short-term benefits to business associated with watered down regulations is worth the potentially long-term damage to society, to the environment, to public trust, and even to people’s belief in the ability of democratic decision making effectively to tackle big problems.

An industry lobbyist cannot look at the persistent rise in extreme climate-related events or the disturbing revelations of human rights abuses in various industries’ supply chains and morally conclude that their role consists of little more than acting as a disinterested industry representative in the marketplace.

Such considerations are highly pertinent in the health care sector. While the role of pharmaceutical companies in tackling the COVID crisis was highly positive in terms of the swift manufacture and distribution of the vaccines, ethical dilemmas for the industry were present nonetheless as it navigated the line between its private interests and public responsibilities.

One example concerned whether those companies that developed COVID-19 vaccines should waive protections for intellectual property and other technical know-how in the interests of more rapid vaccine distribution to poorer communities in the global south.

For critics of EU policy in this instance, the Union was seen to have abandoned its stated policy that vaccines were a ‘global public good’ in favour of an approach that appeared to favour the interests of the European pharmaceutical industry.

This contributed to the situation in late 2021 where only 6% of people in low-income countries had received at least one dose of a vaccine, compared to 73% of those in high-income countries.

The industry argued that without the guarantees provided by patents and intellectual property rights, the EU would undermine the kind of innovation, expertise, and risk-taking that produced novel mRNA vaccines in record time.

The dispute was partially resolved at the World Trade Organisation in the summer of 2022, with a waiver for COVID-19 vaccines finally agreed.

Whatever the merits of the arguments on either side, one thing was clear: when it came to resisting the waiver, the pharmaceutical industry in Europe was able to display its formidable lobbying powers and capacity to influence the EU administration and EU member states. Between January 2020 and September 2022, 13 pharmaceutical lobby groups and companies held nearly 100 meetings with senior Commission officials, spending at least €15 M in 2021.

This represents only a small slice of a much larger campaign conducted across the EU, but unfortunately we do not have reliable data for lobbying in national capitals.

At the very least, the strategy seems to have been to ensure the existing incentives and protections for the industry were preserved in the teeth of an unprecedented pandemic that called for a rethinking of multilateral responses to global health challenges.

The COVID-19 pandemic also saw tragic examples of what can happen when a portion of the population does not trust the scientific and regulatory process or health professionals. What happens is that some people die.

In a climate rife with misinformation and propaganda, it is crucial that governments and businesses avoid even the slightest hint of impropriety when it comes to their work, as every mistake may be weaponised upon by populist politicians and ideologues.

Throughout the pandemic, my Office received various complaints related to transparency around the public procurement of vaccines including the European Commission’s initial refusal to grant public access to advance purchase agreements for COVID-19 vaccines and to other documents related to negotiations with the pharmaceutical companies.

The Commission indicated that it was consulting with the companies concerned and subsequently did publish redacted copies of all the agreements.

Nevertheless, in my view, the time it took to release these documents was needlessly damaging to public trust. I therefore emphasised the need to ensure transparency requirements form part of all ongoing and future vaccine negotiations.

Similar damage to public trust was done when the Commission failed properly to consider a public access request for reported text messages between its President and the CEO of Pfizer regarding the purchase of vaccines.

The way the Commission dealt with this situation, including initially denying that texts fall under its internal criteria for document recording, provoked understandable disquiet among Europeans and much negative media coverage.

In another inquiry, I made suggestions to the European Medicines Agency about how it engages with medicine developers and ensures a separation between the staff who provide scientific advice to developers in the pre-submission phase, and those subsequently involved in evaluating the marketing authorisation application.

My office has also begun an investigation into proactive transparency of clinical trial data. The EMA suspended its policy in 2018 due to its move to Amsterdam and the COVID-19 pandemic. It has since resumed it for products containing new active substances, but it has not said how they plan to deal with clinical data related to evaluation procedures that were completed during the suspension period. As a first step, I have asked when it intends to publish this data, including whether it has plans to prioritise certain product areas.

My mandate however only extends so far. I have no role to in the design of ethics rules, lobbying regimes, or hiring practices in the private sector

Change has therefore to come from within—from ethics and compliance officers such as yourselves, from owners, managers, from shareholders, and from employees.

It is not just about establishing procedures and following best practice; it is about creating a culture of continuous reflection on the strength of its ethical muscle.

Successful industries support jobs and communities, they promote economic growth; in your case, they drive innovation that saves lives. But that does not mean that every single thing that is good for business is good for humanity, especially in the long term.

In the work that you do, it is crucial that to not compartmentalise your duty to your company or institution as separate from your duty to society and to our increasingly fragile planet. Rather, I encourage you to act as agents of change who can steer the role of business in the direction of the public good and of the protection of the environment.

Thank you.