James Browne (Wexford, Fianna Fail) | Oireachtas source

Fianna Fáil will be supporting this Bill which makes necessary changes in a number of important areas of health provision. The Bill was originally published last January, and the delay in bringing it before the House is somewhat unfortunate. Nonetheless, the Bill is to be welcomed. While the Bill is described mostly as being technical in nature, it addresses a number of key issues affecting very vulnerable people in our society, and in that respect it is to be very much welcomed.

I will address a number of key aspects of the Bill. Part 4 amends the Health (Pricing and Supply of Medical Goods) Act 2013. I would point out that last May, Deputy Kelleher introduced a Bill to amend the Health (Pricing and Supply of Medical Goods) Act 2013 in a number of ways. The Minister recommended that it would allow prescribers, consultants and doctors to use biosimilar drugs or other biologics instead of existing medicines, with the aim of reducing the cost of drugs supply, which, as we all know, is a bone of contention.The second Part of the Bill would allow prescribers to prescribe newly diagnosed patients with generic, more affordable medicines instead of branded products. The House would welcome an update in terms of the Minister's view of that area.

I wish to raise the issue of Orkambi. The Minister will be aware that cystic fibrosis, CF, is a genetically inherited disease that primarily affects the lungs and digestive system. Ireland has the highest rate of CF in the world, with one in 19 of our people suspected of having the allele. Last January, CF patients were dismayed by a ruling by the National Centre for Pharmaeconomics, NCPE, which recommended that this groundbreaking drug, Orkambi, would not be made available or funded by the Government. I seek clarification on the stage the Government is at in its negotiations with the supplier, Vertex, to ensure the supply of this desperately needed drug. The NCPE gave it a positive health impact assessment and recognised that Orkambi would have substantial benefits for people who suffer from CF and alleviate their suffering. It seems to be solely a pricing issue. CF patients are particularly distressed by what they see as the current stonewalling by the Department of Health in giving them information on the stage of the negotiations, or even if they are ongoing. The lack of consultation both by the Department of Health and the HSE is unacceptable. In fairness, the Minister should not have to accept these outrageous prices. In terms of ethics, Vertex and other similar companies should address the issue of the prices they are seeking. Unfortunately, we have seen a trend develop throughout the world recently of companies buying drugs that are coming off patent and jacking up the prices. We have seen that happen with regard to the EpiPen and a number of other drugs. Orkambi is a new drug that has a real effect.

I ask the Minister to explain the steps the Department has taken to challenge the unjustified prices and outline whether he has raised this issue at EU Council, EPSCO, level because the pricing of Orkambi seems to be an issue in a number of countries across the EU. I believe Germany has licensed it but there is an issue with the update because of the costs. France, the United Kingdom and other countries have an issue with the pricing also. While these issues are ongoing, and the Minister has to get a fairer deal, it is a travesty that this drug is not available for CF sufferers. Any significant delay is affecting these people. I understand the Minister's difficulties, but he must show CF sufferers the steps he is taking to address these issues, get a fairer price and, importantly, make this drug available for them as soon as possible.

The second issue I want to address is tobacco. Tobacco companies invest huge sums of money in advertising and marketing their products to recruit new customers, who are nearly always children and young people. That is the reason the 2015 Act to introduce plain or standardised packaging was so crucial. Plain or standardised packaging limits the tobacco industry's ability to attract young people by using marketing techniques that are intentionally misleading. Making tobacco products less attractive to consumers, making health warnings more prominent and reducing the ability of the packs people to mislead people, especially children, about the harmful effects of smoking, are critical steps to reducing the attractiveness of tobacco products. The further amendments to the Act, which will help to enable that, are very welcome. However, sections 7 to 14, inclusive, of the Act have still not been commenced.

They must be commenced as soon as possible to address the issues and to take away the ability of these tobacco companies to continue to market tobacco products to young people and new customers. Fianna Fáil seeks the commencement of this absolutely critical step as soon as possible and I urge the Minister to do this. As the Minister noted earlier, Ireland has been a leading country in this area and we can take the lead once again. On commencing this legislation, Ireland once again will become a leader in the implementation of Articles 11 and 13 of the World Health Organization, WHO, Framework Convention on Tobacco Control. However, as we will not be in that position until the Act is commenced, I ask the Minister to so do as a matter of urgency.

I thank the Acting Chairman. I am sharing time with Deputies Jackie Cahill and Marc MacSharry.

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