David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

279. To ask the Minister for Health the extent to which the recommendations of the report by the Oireachtas Joint Committee on Health on evaluating orphan drugs have been implemented; if an impact assessment has been conducted on those which have; and if he will make a statement on the matter. [10674/21]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

The Deputy will recall that in February 2018 the Oireachtas Joint Committee on Health issued its report which contained a significant number of recommendations with respect to the evaluation of orphan drugs.

On 21 November 2018, Departmental and HSE officials, at a hearing of the Committee, reported on progress on the implementation of the various recommendations.

In view of the passage of time since that hearing, I have asked my officials to prepare an updated report for the Deputy on the extent to which each of the recommendations have been implemented.

David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

280. To ask the Minister for Health the process for the approval of new drugs; his plans to review or alter this process; and if he will make a statement on the matter. [10675/21]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

All medicines must be authorised before they can be marketed and made available to patients. In the European Union, there are two main routes for authorising medicines:  a centralised route and a national route.

Under the centralised authorisation procedure, pharmaceutical companies submit a single marketing authorisation application to the European Medicines Agency (EMA). This allows the marketing authorisation holder to market the medicine and make it available to patients and healthcare professionals throughout the EU on the basis of a single marketing authorisation.

While the majority of new, innovative medicines are evaluated by the EMA and authorised by the European Commission in order to be marketed in the EU, most generic medicines and medicines available without a prescription are assessed and authorised at national level in the EU. In addition, many older medicines available today were authorised at national level because they were marketed before the EMA was created.

The Oireachtas put in place a robust legal framework, in the Health (Pricing and Supply of Medical Goods) Act 2013, which gives full statutory powers to the HSE to assess and make decisions on reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate. In line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

Reimbursement is for licensed indications which have already been granted marketing authorisation by the EMA or the Health Products Regulatory Authority. In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess a drug's clinical and cost effectiveness as a health intervention.

As Minister for Health, I have no role in decisions relating to either the authorisation or reimbursement of medicines.