Mick Wallace (Wexford, Independent) | Oireachtas source

I would like to look at a couple of sections of the Bill. Section 8 refers to payments made under schemes for individuals disabled following the thalidomide tragedy that took place in the 1960s. The Health Products Regulatory Authority has a role in this context. Thalidomide was marketed as a sleeping pill and morning sickness cure in the late 1950s and early 1960s. It led to the deaths of tens of thousands of babies who were born with malformed limbs worldwide. Only 50% of affected babies survived. This horrible outcome led to an overhaul of the regulation of medication in the west and the aggressive marketing of the pharmaceutical industry was reined in. That was the plan, anyway. Three major steps were taken. First, new drug development was rewarded with product rather than process patents.

In other words, the idea was to ensure that the regulators could target the company responsible for making a given drug and hold it responsible if anything went wrong. Second, new drugs were made available on a prescription-only basis. The system had pluses but, as we know now, it created different problems and it has been a licence to print money for some. Third, proof was required that new drugs worked through controlled trials before they could be marketed.

This all sounds like a good idea but issues have been identified by a very knowledgeable individual called Dr. David Healy, who was born in Raheny in Dublin. He is currently professor of psychiatry at Bangor University in the United Kingdom. He is a psychiatrist, a psychopharmacologist - it is difficult to say that word - and a scientist. In any event, he is, by all accounts, a brilliant individual. Dr. Healy has documented in detail how the aims of these innovations have been circumvented by people in the pharmaceutical industry to advance their aims. His comments are worth putting on the record: "... increasing numbers of pregnant women who religiously steer clear of alcohol, tobacco, soft cheeses, or anything that might harm their unborn child, but who are nonetheless being urged by their doctors to take drugs like the antidepressants – now the most commonly prescribed drugs in pregnancy – even as the evidence accumulates that these drugs cause birth defects, double the rate of miscarriages, and cause mental handicap in children born to mothers who have been taking them".

The efforts to protect ourselves from a recurrence of the thalidomide disaster have been a disaster. Product patents give an incentive to pharmaceutical companies to produce drugs that are so valuable to them and their survival that the incentives to breach regulations and hide any safety data that might be inconvenient for the companies are extraordinary. Entire trials are hidden. Almost all trials are ghost-written to ensure the data looks right. No one, not even the US Food and Drug Administration, has access to the data.

Prescription-only status has made doctors the conduit for prescription drugs. Company marketing can concentrate on these few consumers and understand them better than they understand themselves. Doctors claim to be shielded from company marketing by guidelines and evidence-based medicine, seemingly unaware that pharmaceutical companies are now the most enthusiastic advocates of guidelines and evidence-based medicine.

Clinical trials were introduced as the eye of the needle through which the financial camel that is the pharmaceutical industry would have to squeeze if it wanted to get drugs on the market and make money. These trials would establish whether drugs worked and would lead to a clear recognition of their hazards. Despite this, we have been led badly astray. The most extraordinary example of how badly is the fact that the one drug that has been through a controlled trial before it was marketed and which had been shown to be safe and effective was thalidomide. This is the system on which we now depend to avoid future drug disasters. Once trials were put in place, industry took over the running of them. More than 90% of all clinical trials are now run by private companies. They organise ethical approval through other private companies and outsource the trials to parts of the world where oversight is at a minimum. The results, sometimes stemming from patients who do not exist, are fed back to the parent companies. They are coded in a manner that often causes problems to vanish. These trials and the results that suit company marketing agenda are then written up by ghost-writers and published in leading medical journals, even though the editors know what is happening and that they are putting lives at risk by publishing these articles. If something goes wrong with a drug, the industry claims that no one can link the drug to the problem unless a clinical trial has shown there is a statistically significant link. Everyone buys this such that even when serious problems arise with a drug, clear up when the drug is stopped and reappear if the drug is reintroduced, industry players can deny a link and can expect regulators and academics to line up behind them.

The function of Part 3 is to allow for expense fees to be paid to the board members of the Health Products Regulatory Authority because of an expansion in the functions of the organisation. There is "an onerous responsibility and significant time commitment placed on the members of the Authority". It sounds as if they may be overworked and understaffed - I do not know. The HPRA does valuable work but there is a limit to what the authority can do, as Dr. Healy has shown. There is an element of corporate capture in the regulation and approval of pharmaceutical products. Has the HPRA conducted independent trials into the eight most widely prescribed selective serotonin re-uptake inhibitors used to treat depression in Ireland or is the authority box-ticking the results of trials carried out by the private sector, the manufacturers or companies with business ties to the manufacturers? I am raising this because of growing concern around the links between antidepressants in the form of SSRIs and self-harm, depression, violence and suicide.

The former assistant state pathologist, Dr. Declan Gilsenan, and Dr. David Healy raised these issues with the former Minister of State with responsibility for mental health issues, Kathleen Lynch. Dr. Gilsenan argued that in his 30 years of experience carrying out post-mortems he had seen too many suicides after people had been taking SSRIs and called for a national survey of suicides to see how many people had begun taking SSRIs shortly before taking their lives. The former Minister for State commended Dr. Gilsenan for speaking out about the connection between SSRIs and suicide and stated, "When someone of this stature speaks out, we have to take notice". She continued:

GPs have found themselves in a position where there is nothing else to do but prescribe pills. There needs to be alternatives for people. It can’t just be medication, and we need a system where people are reviewed on a continuous basis.

This was a very good statement on the part of the then Minister of State. I agree that there needs to be more contact and monitoring of a patient's progress, especially when on these medications, but GPs and the drugs themselves have to be monitored as well. What if a GP is over-prescribing? Does the GP have the skills to help people come off the drugs? Does the GP give the proper warnings, furnished to her by the HPRA, to the people to which she has prescribed the drugs? Do the doctors respond properly to complaints about the drugs and unexpected side-effects or do they continue with the prescription? Do GPs refer these complaints to the HPRA? Does the HPRA add these side-effects to the information leaflet it provides to GPs and other professionals? Does the HPRA review the efficacy of these drugs in light of these complaints?

Part 4 allows for certain over-the-counter medicines to be made available free of charge for medical card holders, for example, the morning-after pill. While this is a welcome measure and should make this treatment more accessible financially, there is an issue with the fact that in order to obtain the morning-after pill on a medical card, it will now be necessary for the patient to get a prescription. In 2011, the Irish Medicines Board approved the morning-after pill as an over-the-counter medicine in response to growing demand. The earlier this pill is taken, the more effective it is. Given the time-sensitive nature of taking this medication, reintroducing a delay for those with medical cards is completely unfair.

Ireland takes a medieval stance on women's reproductive rights. There is already a two-tier system in place. There are those who can afford to travel abroad for abortions and those who cannot. Introducing an extra barrier in obtaining emergency contraception is simply another way in which the State can interfere with the reproductive rights of women.

Requiring people to go to their general practitioner to obtain a prescription for products that usually do not require prescriptions seems like a waste of time and resources. Will the State have to foot the bill for these additional GP consultations? Will GPs be required to spend their time in consultations for products that are already available over the counter? Considering the recent findings of the National Association of General Practitioners that the average waiting time for a GP appointment is 34 hours it would be counterintuitive to add unnecessary consultations into the mix. If there is a need to safeguard against people taking advantage of the new system, for example, by stocking up, the responsibility for assessing whether someone needs the morning after pill should remain with the pharmacist.

I have concerns in respect of Part 5 of the Bill that the looming provisional application of the Comprehensive Economic and Trade Agreement, CETA, between Europe and Canada and the impact it will have on this kind of legislation is being ignored. The investor-state dispute settlement, ISDS, mechanism that is built into CETA will shortly give corporations with bases in Canada the legal right to punish Ireland for this Bill which is designed to protect the wellbeing of Irish people. I and others have raised this issue numerous times, never to have it adequately addressed. There does not seem to be a very serious appetite in this institution for dealing with the Transatlantic Trade and Investment Partnership, TTIP, or CETA, which is very worrying. There are very serious concerns for the Irish people that are not being addressed and it would be a terrible shame if we did not address them properly and inform people about what is really involved because there is a serious lack of information around it, a lot of secrecy and there is a certain element of education to be engaged in on the part of the State. It is only fair that people should know what is going on, what is involved, what it means and what it will result in because the implications are enormous.

At the start of July Deputy Pringle asked the Minister for Jobs, Enterprise and Innovation 11 very specific questions about the ISDS mechanism that is contained in CETA. The Minister grouped the questions and made no reference to ISDS in her answer. Instead, she simply copied and pasted the official advertisement for CETA. That is not very good. Investor-state dispute settlements, dispute resolution mechanisms, the investor court system, regulatory cooperation and the text of the trade deals make clear that these elements of CETA and TTIP create a situation where corporations get privileged advance warning of upcoming legislation that will affect their profits so that they can start changing and influencing legislation before it is voted on. Failing that, if existing or newly implemented legislation impacts profits, real or potential, they can sue national governments for loss of profit. Most worrying is that CETA is about to become provisionally applied after a European Council vote on 18 October, which under the treaty on the functioning of the European Union means that it will come into full force and even if subsequently our national Parliament, the European Parliament or the Council of Ministers vote against it, it will remain in place for three years.

The decision to let European parliaments vote on the trade deal is meaningless if the Council of Ministers gives it a qualified majority vote. This point was raised by Deputy Maureen O’Sullivan with the Taoiseach and by me with the Minister for Jobs, Enterprise and Innovation on the last day of the Dáil term before the summer recess. In both cases the point was not addressed or appreciated but was glossed over with talk about TTIP and quotes from flawed research about projected future growth in gross domestic product, GDP, even though the questions were about CETA. The Government has repeatedly refused to engage with the real dangers of these trade agreements. It completely ignores them to the extent that it is almost certain that the Taoiseach will vote to apply CETA provisionally come 16 October.

In 2010, in just one of the thousands of ISDS cases that corporations have taken against states attempting to regulate in the public interest, Philip Morris, the tobacco company, sued Uruguay over its plain packaging laws for tobacco. The case went on for years but eventually collapsed on a technicality to do with the subsidiary Philip Morris used to bring the case. Philip Morris, Imperial Tobacco and Japan Tobacco Limited all sent letters to the Irish Government threatening to challenge legally the plain packaging legislation we introduced in 2015.

There is also opposition to the legislation put forward here today on the basis of infringements of property rights and free trade. The Taoiseach will go to Brussels in two weeks effectively to hand over to the tobacco giants the right to sue us successfully in respect of these objections. In essence, the Government is proposing legislation and the leader of that Government is acting against the spirit of the legislation. Most people who understand how the system works would be of the view that the influence and power of big business has probably never been greater in the history of the planet. The potential for states to hold it to account is diminishing because its influence is so great. The Nice and Lisbon treaties played a part in that. For example, a bypass is being built at New Ross in County Wexford. We are not allowed to borrow money at 1% which the Government could do because according to EU rules it would go on our books and break our 3% rule and we would be in different trouble. We have to go to a public private partnership, PPP, where at a minimum the money is costing in the region of 15%. We are paying 15 times more for the money to build the bypass at New Ross than we should be paying. That is only one example. We are building schools under PPPs. The money is costing 15 times more than it should. Where is the rationale behind that? How can the Commission say that it is legislating in the best interests of the people of Europe if it is driving the states and governments of Europe into the hands of the private sector to be used and abused because that sector has a licence to make crazy money off the European states because of the rules and regulations it has introduced. On our own little patch in Ireland if the full light of day ever shines on the workings of the National Asset Management Agency, NAMA, it will show how we do business and it is rotten to the core.

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