I move:
That leave be granted to introduce a Bill entitled an Act to amend the Health (Pricing and Supply of Medical Goods) Act 2013 to allow interchangeability between biologic and biosimilar medical goods.
I am pleased to introduce this short Bill, which I hope can reduce the large bill of up to €2 billion that we face each year for medicines in our health services. The Department of Health and the HSE have failed to get value for money on behalf of the taxpayer. At a recent meeting of the Committee of Public Accounts, it was confirmed that the renegotiation of the deal between the Government and the Irish Pharmaceutical Healthcare Association, IPHA, which was due to expire at the end of October, had not proceeded because the Government side was putting together for the first time a full, centralised national database of all medicines being purchased on behalf of the taxpayer. The State purchases medicines for use in acute hospitals and community settings and for prescription by general practitioners, GPs. It is an indictment of the HSE and the Department that they have not had all of this information in one place to date. It is essential that we do so in order to reduce the cost of medicines and improve the Government's negotiating position in respect of these contracts.
The proposed Bill would amend the Health (Pricing and Supply of Medical Goods) Act 2013 in two ways. First, it would allow consultants and doctors to choose biosimilar drugs, or biologics, instead of existing medicines. Biologics are medicines that are made by or derived from a biological source, such as a bacterium or yeast. They can consist of relatively small molecules such as insulin or more complex ones. They are more affordable and are the norm across Europe, but Ireland has refused to adopt them. My proposed Bill would allow for patients to be switched, where appropriate, from existing medicines to more affordable, but equally effective, biosimilars. This is not allowed under the current legislation.
Second, the Bill would allow doctors and consultants to prescribe all newly diagnosed patients with generic, more affordable medicines instead of the branded, expensive medicines that we have currently. For some conditions, doctors and consultants continue to prescribe the more expensive branded medicines for newly diagnosed patients. The 2013 Act provides an exemption allowing the prescriber not to substitute a branded medicine for a generic one in particular circumstances. We all agree with this, but while generic substitution is not recommended for patients on existing treatment regimes, there is no reason new patients seeking treatment for the first time cannot be given more affordable generic alternatives. That is what the Bill proposes to do. Prescribers should move to generics when there is no good medical reason not to do so.
The proposed measures have the potential to deliver savings for the taxpayer. Savings from the use of biosimilar medicines are in the region of €40 million per annum, while savings from the use of generic medicines can amount to €10 million, giving a total saving of €50 million every year. We need to do this, as that €50 million could be put to better use in the health service.
The national procurement office should be given the task of managing this contract. I have called for that year in, year out and we have included it in our annual budget submissions. I am delighted that a national database is being put in place for the first time. Shame on the HSE and the Department of Health for entering into an agreement with the companies when they did not even know the full extent of what they were purchasing.
Recently, I met representatives of the IPHA and the Healthcare Enterprise Alliance regarding the cost of drugs. They contacted me after I raised this general issue at the Committee of Public Accounts and I was happy to meet them. The Health Products Regulatory Authority, HPRA, is responsible for the establishment, maintenance and publication of a list of interchangeable medical products. This list allows the HPRA to group medicines that are deemed interchangeable with one another. Doctors can then prescribe and pharmacists dispense medicines within that group. Everything that I have suggested would require the HPRA's normal approval of medicines. There would be no question of a doctor or consultant prescribing a medicine on the basis that he or she believed it had done well in Europe. It would have to be approved in Ireland by our statutory agency.
My Bill provides for the removal of section 5(7)(d) of the 2013 Act, which prohibits the substitution of biologic and biosimilar medicines for medicinal products. Some people will not get this, but it is happening in Europe, which is far ahead of us. These medicines should only be used where they are deemed equally effective and there is a saving to the taxpayer. I am pleased to commend the Bill to the House.
