Speaking during the Address to Seanad Éireann by Nessa Childers, MEP
I welcome Ms Childers, who has been a wonderful ambassador for our country in the European Parliament. I speak as a committed European and, in many ways, as an anti-nationalist with a small “n”. I have this theory that, in 50 or 100 years time, people will look on the concept of nationalism in a somewhat similar way to the way they look on the concept of racism now. I do not necessarily think it a great idea.
I would, however, like to say that from a practical and democratic point of view, harmonisation, laudable as it may be in many areas, should not be an end on its own. It should not be an absolute goal we aim for because harmonisation sometimes means winnowing things down to the lowest common denominator rather than striving to the highest plateau, where things are at their best. This has certainly been the case with some aspects of health and research. There have been a few areas in recent years where an attempt to enforce harmonisation has had potentially negative, and in the future could have potentially disastrous, consequences on areas that are very close to my heart, for example, clinical trials.
About seven years ago, Europe introduced the clinical trials directive, which attempted to address the kind of chaos many people who work in bureaucracies do not like when they see dissonant sets of criteria and goals, and different jurisdictions over which they have some kind of loose authority doing the same jobs. It just happened there were very different ways of approving clinical trials in Europe and an attempt was made to harmonise them. As part of the harmonisation process, a number of the measures which were introduced, which I will not bore my colleagues with today, are now generally recognised to have been very negative. However, because this passed the Commission and then passed the Parliament, there was not a mechanism in Europe to roll it back.
At the time that harmonisation was dawning, a few of us started an information campaign to try to get people to wake up to what they had actually signed up to. We were told politely that, because it had passed both entities, it is now written in granite, cannot be changed and we are stuck with it. Luckily, it was a directive and not a regulation, which basically meant we could ignore it, although people did not quite understand it at the time. There should be a big learning curve attached to that.
A regulation is now coming in and I believe it needs real and careful attention. The instinctive, visceral harmonisers, well-intentioned as they may be, as they are not familiar with the realities on the ground of how a lot of research works, may end up taking some of the worst jurisdictions from the point of view of research and enforcing their standards on the rest of us. Without in any sense being disrespectful to our near neighbours, clinical trails in the United Kingdom have been extremely difficult to conduct in recent years. The approvals process has become so long that many British patients, in particular British patients with breast cancer, have been denied early and expeditious access to drugs which could have been very beneficial for them. I greatly fear that, in pursuit of compliance with forthcoming European regulations, the same kind of regressive regime may be imposed here. In the next month or two, I hope we will be looking at this closely in a number of fora in our own jurisdiction, but I would like to mark Ms Childers’s card that there are problems with it.
Other collateral damage which arises from good intentions relates to the attempts to bring in data protection legislation. Those who wish to bring in such legislation have their hearts in the right place in that they are trying to protect private and personal data that people may have online and so on. However, they did not think it through to the extent that there is a real risk the kind of cancer and other research which involves collecting specimens in many cases from people who are deceased - this is the kind of research that enabled us to introduce a number of critical drugs like Trastuzumab, otherwise know as Herceptin – could not take place now under the new regime because dead people cannot give consent to have their anonymised materials used for research purposes. Again, not only is the baby going out with the bath water, there is potential for real disaster which needs to be addressed.
On the issue of drug pricing, there is a bigger picture. In Ireland, we have been misinformed about what we need to do. Obviously, we need to move in a large way to the use of generic drugs and the cheapest alternative drugs. As I said, I have voted with my own health on this. I now insist on taking a generic cholesterol lowering drug myself and I believe everybody should insist on getting the cheapest generic drug for whatever conditions they have.
However, there are some things we cannot do in this jurisdiction. I want to draw attention to something that is happening with cancer drugs. For many years, we had no new meaningful cancer drugs because science and technology had not yet caught up with the theoretical science to give us new drugs. There has been a revolution in this regard. In the last decade we have seen several drugs per annum and in the last few years we have seen several drugs per month coming out, with data which looked extremely promising. People have this idea that drugs have been priced by some kind of a mark-up principle on top of the development cost of the drug. That is changing. What is happening now is that highly technically proficient and skilled marketeers, using the principles, theory and practice of marketing, are trying to work out what is the highest price one can charge at which the inflection point for demand occurs – when it becomes elastic and people will basically say we will no longer pay for that drug because it is too expensive. They are pitching for the very highest point on that curve.
Coupled with the kind of emotional blackmail which is built into the availability of new drugs, we have the situation where a drug like Herceptin, with which I was very involved, cost about €30,000 per annum to provide. However, I know the trials that were used to licence Herceptin involved 15,000 patients, so there was an expense involved in developing the drug. There are drugs coming out now that are being priced at between €100,000 and €200,000, and I know in the case of one drug that the licensing trial which led to this drug being licensed involved fewer than 100 patients. There is an absolute, utter and complete mismatch occurring between the development costs of drugs and what companies are going to attempt to charge for them in the future. This is because of market forces. While I am broadly sympathetic to market forces when they are true markets, this is not the case with regard to monopoly markets, which is what drug companies with a new product for an emotionally draining cancer have.
What we need to do collectively in the Western world, including in Europe and with our colleagues in other parts of the Western community of similar democratically and economically constituted countries, is to have a concerted policy which will say to the companies “You make great products and you deserve to make a profit, but this is the limit and we are never paying more than this for any drug you come out with. Learn to live with it, make the drug viable and it can be done.” This is something we will be attempting to launch as an information campaign over the next while.
I heard Ms Childers’s comments on second-hand smoke exposure. I am the sponsor, together with Senators van Turnhout and Daly, of the legislation which we hope, perhaps in this session, will result in one of the successors to Ms Childers’s late, great father’s office signing legislation which will make it illegal to smoke in cars in which there are children. We are trying to go further. What we are trying to do is to create a debate in Europe around the idea that the tobacco trade, which is a part of the drug trade, is not just something we should be regulating and reining in, it is something we should be ending. People may have a right to smoke, and I do not dispute that, but no one has a civil right to addict children to cancer-causing chemicals. It is absurd to think there is a civil liberty to make a profit from selling cancer-causing addictive products whose very commercial continuation depends entirely on recruiting new underage smokers to the ranks of the abusers.
That is why we have started a campaign called SOS 2030, which has a website I hope Ms Childers will sign up to and ask all her European parliamentary colleagues – a minority of whom, I presume, do not smoke – to sign up to. This will commit us to the idea that we will start the wheels rolling so that by the year 2030, after we give the farmers time to grow something else, give the pension funds time to divest and give the factories a chance to re-tool the plants and to make food products rather than tobacco products in an increasingly food deprived and challenged world, it will just not be legal to engage in any commercial transactions with tobacco.
People might argue that this will encourage smuggling and the black market. Yes, it will but if the people in the boardrooms of British American Tobacco, R. J. Reynolds and all these other entities wish to sell tobacco by that date, they will be doing it with the same commercial plan and according to the same business model as the Medellin or Cali cartels or the Taliban in Afghanistan. If they wish to continue doing it, let them do it. It will suck the money out of the PR companies and lobbying agencies which have so polluted public policy in this area. It may sound a bit quixotic but it is something we should aim to do and I believe it is quite practical to get people to sign up and join it now. I thank Ms Childers for the opportunity to meet her again and look forward to working with her on a number of these health-related issues in the future.
