david brennan istanbul speech[1]

8/4/2019 David Brennan Istanbul Speech[1]

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David BrennanFifth International Pharmaceutical Regulatory

And Compliance Congress, Istanbul

04 May 2011

Good morning. I am delighted to be here delivering this mornings

keynote address.

We meet at a time of turbulence and uncertainty across the world

and that is presenting challenges to virtually all business sectors. So,

while we hope that the worst of the economic crisis is over, we areseeing major social and political changes in many countries. We are

also dealing with rapid and far reaching technological developments

that are transforming both our personal and our business lives.

The pharmaceutical industry can and does play a positive role in

meeting those challenges. It is a force for good.

But if we are honest with ourselves, that is not how we are perceived.

Were often seen as the bad guys. People dont trust us to do the

right thing.

In a Harris poll conducted in the US last year only 11 per cent of

people said they thought the pharmaceutical industry was generally

honest and trustworthy. Perhaps more worrying still was the fact that

20 per cent said they thought banks were honest and trustworthy. So

even three years on from one of the worlds most far reaching

financial crises, the banks are still seen as more honest than our own

sector.


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Theres even more bad news, in that this low level of trust has not

changed much since the survey first started eight years ago.1

Of course, these are just one set of results and I am sure that they

will vary in different markets. But whatever the precise figures, it is

clear is that our reputation is not as good as it should be.

It is easy to dismiss this as something we cannot control. That these

are perceptions and not reality. But I firmly believe we can and

should do something. That we can change the way we do things so

that we set the highest standards so that we never do anything that

can be misinterpreted. And that we recognise that how we do things

is just as important as what we do.

We do have very effective national and international codes of

practice in place and responsible companies make strenuous effortsto ensure they comply with those codes. But we have to do more.

We are already seeing the real costs of failing to act according to the

highest standards. It has been reported that in the last five years

pharmaceutical companies have paid $14.8 billion in penalties to the

US Government for alleged violations of a variety of laws and

regulations. The biggest proportion of these fines related to allegedoff-label promotion but there were other alleged violations as well.

Clearly, all these cases are different and it would be inappropriate for

me to comment on the detail. But we can draw some conclusions.

1http://www.harrisinteractive.com/NewsRoom/HarrisPolls/tabid/447/ctl/ReadCusto

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The first is that the numbers of violations and the size of the penalties

are increasing. The second is that this is in no ones interests, it

diverts time and money away from improving healthcare. And the

final point is that it is clear that this means there is little trust in the

system.

I know that there will be those who think that this is just the way

business is done these days. And that disputes with regulators are

inevitable. There will also be those that argue that there is a conflict

between being competitive and ethical. I disagree. I believe the

reverse is true. Acting with integrity gives us our licence to operate, it

means we regain public trust, it means we can put more of our effort

into developing the products that patients need.

We all accept that regulation is necessary, that compliance has to be

at the heart of everything we do, but excessive regulation can reduceeffectiveness. It can slow the approval of new drugs, it can divert

resources, it can stifle innovation. Thats not good for the industry but

more important its not good for patients.

But industries that are not trusted are more heavily regulated. The

Harris poll I mentioned earlier also showed that the sectors the public

trusted least were the ones where they wanted government toimpose more regulation. And governments respond to that pressure.

And, as a result, we tend to end up with a box ticking culture which

believes simple compliance with the external rules is enough. But

good governance and good corporate behaviour are much more than

compliance. It is about having values and principles and always


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doing the right thing. It is about setting the highest standards of

behaviour and never doing anything that could be misinterpreted.

And it is about thinking about how we do things and how we can do

them better to maximise the benefits of what we do.

So at AstraZeneca we have embarked on programme that puts a

renewed and reinvigorated focus on acting with integrity at the centre

of what we do and how we do it. We start from the position that our

products stand on their own merits. We believe in them. So

healthcare providers should know about their benefits but we should

not do anything that could be seen as an inducement to use that

product.

These are easy words to say but we mean them. And we are

changing the way we operate to reflect them.

Now, in our Global Policy on External Interactions, we have an

explicit ban on providing any gifts, other than low monetary value

cultural items and educational items to healthcare professionals. We

are still committed to providing accurate information about our

products to healthcare professionals in a variety of forums. And we

will continue to provide opportunities for healthcare professionals to

learn about our products both by our own employees and by otherhealthcare professionals whom we train as speakers. However, we

have decided that we will no longer pay for doctors to attend

international scientific and medical congresses but will instead focus

our educational efforts on local educational opportunities for

healthcare professionals.


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Our main focus in all of our educational and promotional activities

with healthcare professionals will be to provide quality educational

programs, and to avoid anything that could be perceived as an

inappropriate inducement to a healthcare professional.

We believe that by making these very clear commitments about how

we promote our products, we can gain an advantage from doing the

right thing.

I know that this is not easy. Its especially difficult for our sales force.

I know from my own experience as a sales representative, you will

encounter people who will ask for gifts, or other inducements. And

they will threaten to take their business elsewhere, if you dont

acquiesce.

But we have made it clear that our sales force have to say no. They

must do the right thing, not the easy thing. They must understandand abide by our principles, and our Code of Conduct. Let me read to

you one sentence from our Code, Our Promotional Activities and

Promotional Materials must be free from ambiguity and allow the

therapeutic value of our Products to be assessed by healthcare

professionals in the interest of optimal patient care.

Those words are clear but we also know that the principles are notenough on their own. We need to support every member of our sales

force when they face difficult situations so the Code provides a clear

guide to real life situations. And it underlines that anyone who takes

those tough decisions will have the support of their managers. And

anyone who doesnt will not.


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It is not surprising that there is some resistance to these changes.

Perhaps the most difficult argument for us as a global company is

that a universal approach is wrong, that one size does not fit all that

in different markets we need to tailor our approach to local culture. I

understand that, because in every other aspect of our work, we do

empower local managers and allow them to tailor their approach to

local needs. But this is different. In reputation, in gaining trust, you

are only as strong as the weakest link in your chain. Inconsistency

undermines trust because it creates room for ambiguity. And for all

the reasons I outlined at the beginning of my comments, we cannot

afford for there to be any ambiguity about the way we operate and

the standards we set.

We have to understand that in todays interconnected world there is

nowhere to hide. Allcompanies, not just the multinationals, arecoming under closer scrutiny than ever before and stakeholders and

the public will highlight any areas where a company is not living up to

its values. That is another reason why the focus of regulators needs

to be across the whole sector. It only takes one company to taint our

reputation, no matter what good work others are doing.

In that regard I should also mention my role as President of theInternational Federation of Pharmaceutical Manufacturers and

Associations. I am pleased to say the IFPMA is also working hard to

ensure universal standards of ethical promotion, promote greater

trust and improve reputation globally, particularly in the developing

world where trust in the industry is perhaps at its lowest ebb.


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Where national regulations do not exist or are lax, the IFPMA

marketing code plays a key role in providing assurance that the

industry will operate to minimum standards regardless of local law.

The IFPMA, like AstraZeneca, is looking to ways that its code can be

tightened in order to guarantee higher standards of behaviours in

changing operating environments. Through AstraZenecas own

global outreach programme, we aim to help the IFPMA in its goals for

the ethical promotion of medicines globally.

I think that is why it is important to recognise that this is not just about

an individual code or policy, it is about our mindset, our fundamental

values and they have to be at the centre of everything everyone

does, every day.

I see four key aspects to creating that mindset.

The first is to provide role models - and we have been focused on

ensuring that our senior leaders are developing and demonstrating

how we want everyone to behave.

The second is to make sure everyone understands what this

approach means. And we are providing extensive training and

guidance because we know there will be difficult situations whichpresent new problems and everyone needs to understand what

specifically is allowed and what is not and where to get advice and

support if that it not clear.

We also need to ensure everyone has the skills to deliver new ways

of working, within the framework of the Code, including novel ways of


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working with our customers to get them the information they need.

And we have now put in place comprehensive training plans for all

customer-facing employees to support them in this work.

Finally, we have formal global compliance framework which supports

this work. The framework includes our Code of Conduct, which

provides direction and guidance on how our core values are to be

translated into practice. The Code, in turn, is supported by global

policies and further underpinned by functional standards and

procedures. These include our disciplinary and appraisal procedures,

and our whistle blowing policy.

I recognise that this is not just a change for our employees. Our

customers too will see a difference in the way we work with them and

to some of the approaches we have taken in the past. So we are

making sure that we explain to them what we are doing and why weare doing it. We are taking the time to talk to health care

professionals, patients and policy makers so we can be clear about

their needs the kind of information they trust, the way they want to

receive that information and how we can demonstrate to them that

we are always acting with integrity.

I believe that we will get their support because it is in all our intereststo regain that public trust I outlined earlier.

We also have the challenge of applying this to the third parties with

whom we work. Many large organisations have found themselves

vulnerable because their partners have not upheld the same

standards that they themselves advocate. We cannot ignore this


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difficult problem. If we are in partnership with others, we will engage

with them about the new principles in our Global Code and help

them, where appropriate, to internalise these principles as their own.

So we are talking to our partners. We are supporting them to change

their approaches where necessary and we are updating our

agreements so that everybody is clear about what is acceptable and

what is not.


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Of course, this will mean different ways of doing things. And we see

this as an opportunity. Technology now offers huge opportunities to

present to large audiences through webcasts and other media. That

means that information can be provided cost effectively and

transparently, to the particular benefit of professionals in emerging

markets.

As I said at the beginning of my speech, we are living in testing

times. Our industry faces real challenges related to the costs of

healthcare, the drug pipeline, patent expiration and our reputation.

Many of the changes in the external environment are outside our

control. But there are some things we can do to make a difference.

And central to that is working to improve our reputation. A good

reputation has never been more important to business success than

it is today.

It is vital that our industry shows how it can ,and does, play a positive

role in meeting the healthcare challenges we face. And that we

remember we can, and should, be a force for good, and that we give

the highest priority to showing the public that they can trust us to do

the right thing.

That is why for me, and I hope for everyone across the industry,acting with the highest standards of integrity in everything we do

should be our most important priority.

david brennan istanbul speech[1]

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