Stakeholder views on HPRA Strategy 2016 - 2020 1 WHO WE ARE AND WHAT WE DO The HPRA is the regulator of health products in Ireland. Our mission is to protect and enhance public and animal health through the regulation of medicines, medical devices and other health products. In carrying out our regulatory functions, the HPRA puts the health of people and animals at the core of everything we do. We use our scientific and clinical expertise to review and monitor health products available in Ireland or exported abroad. Our aim is to make sure that the health products we regulate are as safe as possible and do what they are intended to do. The full extent of our competent authority activities, which have been granted to us by government over the past 20 years, are shown in the functions matrix available on our website. 2 OUR CURRENT STRATEGIC PLAN FOR 2011 – 2015 The current Strategic Plan covers the years 2010 to 2015 and is based on the following five highlevel goals, each of which has a number of objectives and activities which have informed our annual business planning and reporting. 1 Enhance healthcare product safety and patient outcomes by effective risk management and market surveillance. 2 Deliver clear, relevant and timely communications to patients, consumers and healthcare professionals. 3 Improve service delivery within a high quality, risk-based regulatory framework. 4 Influence legislation and policy development at European and international levels for the benefit of public and animal health. 5 Build future capabilities to meet evolving regulatory requirements, and scientific and technological advances. As we begin the development of the next strategic plan to cover the years 2016 – 2020, we invite all stakeholders to give their views on areas that are relevant to them, using the format below, firstly in relation to product areas and secondly in relation to key high-level areas. 1/4 3 STAKEHOLDER VIEWS ON REGULATED AREAS Human medicines Our role in relation to human medicines is to ensure the ongoing safety and quality of medicines, from clinical trials through to production and supply to distributors and pharmacies and other retailers. We will continue to licence new medicines which contribute to the safe and effective treatment of patients’ medical conditions, and to work with EU partners, healthcare professionals and patients when any identified risks need to be managed for optimum patient benefit. As a key stakeholder we are interested in your views on what you feel our priorities should be in the next five years in regulating human medicines on the Irish market. Click here to enter text. Medical devices Monitoring the safety and performance of medical devices on the market in Ireland is a key function of the HPRA as well as the designation and oversight of Irish notified bodies. The regulation of medical devices will undergo significant changes during and beyond the lifetime of this next strategic plan with EU proposals for a new regime expected to be agreed by the end of 2016. While the specific details of the new regulatory regime are still under discussion, we wish to seek your views on how and where we should focus our resources over the next five years. Click here to enter text. Blood, tissues and organs Our role is to ensure the quality and safety of blood and blood components used in Ireland. In relation to tissues and cells, we ensure that standards of quality and safety are adhered to for their donation, procurement, testing, processing and preservation. We also ensure the quality and safety of human organs intended for transplantation. In your view, are there specific areas you feel could be prioritised by the HPRA over the next five years? Click here to enter text. Veterinary medicines Our role in regulating veterinary medicines is similar to that in regulating human medicines. However the European Commission has recently published proposals for a radical change which would mean that the regulatory system would be quite different from the current one. Discussions are at an early stage between the Commission and the Member States, and may result in significant amendments to the proposals; nevertheless we would like to hear your views as one our key stakeholders, on what you feel our priorities should be in the next five years. Click here to enter text. Stakeholder consultation 2015 2/4 Scientific animal protection The HPRA regulates the use of animals for scientific purposes by means of authorisation at three levels: breeders/suppliers/users; projects; and individuals. This authority was transferred from the Department of Health which regulated this area until the end of 2012. As we further develop this function, are there particular views you have, as a stakeholder, in how we should develop this area? Click here to enter text. Controlled substances The HPRA’s role in the regulation of controlled substances include the issuing of licences for precursor chemicals and the preparation of other licences under the Misuse of Drugs Act for issue from the Department of Health. It is expected that the responsibility for issuing other licences will be transferred from the Department of Health to the HPRA in time. Any views you may have on specific priorities or areas of concern would be welcomed. Click here to enter text. Cosmetics Our role is to regulate the manufacture, sale and supply of cosmetic products in Ireland, and to identify and address cosmetic product quality and safety issues, in conjunction with the Health Service Executive (HSE). Please let us know your views on what our priorities should be for regulating cosmetics over the next five years. Click here to enter text. 4 OTHER AREAS We also welcome your views on the actions we can take in a number of key areas to continuously improve how we: communicate with our stakeholders; contribute to patient, public and animal health within Ireland and abroad; influence the development of the regulatory system; and enforce the legislation. Please add your comments to the following table. Stakeholder consultation 2015 3/4 Area Communications and stakeholder engagement Your comments Click here to enter text. Contributing to the national health system in Ireland. Click here to enter text. Contributing to the network of competent authorities in the EU and internationally Click here to enter text. Influencing legislation and policy development Click here to enter text. Enforcing the legislation for medicines and medical devices Click here to enter text. Any other comments? Click here to enter text. 5 YOUR DETAILS Name Click here to enter text. Organisation Click here to enter text. Address Click here to enter text. Contact e-mail or telephone number Click here to enter text. Thank you for your contributions which are greatly appreciated. Please e-mail this form to strategy.consultation@HPRA.ie by the deadline of 27 March 2015 or by post to: Chief Executive’s Office Health Products Regulatory Authority Kevin O’Malley House Earlsfort Centre Earlsfort Terrace Dublin 2 Stakeholder consultation 2015 4/4