Council of Patients' Organisations of the Minister of Health - summary of first months of operation

The Council of Patients' Organisations of the Minister of Health, established by an order of the Minister of Health of 16 March 2022, is the first permanent body in the history of the Ministry of Health consisting of representatives of patients' organisations, with the task of conducting dialogue on systemic issues in health care and exchanging views on issues most relevant to patients. The need for the Council was recognised by both the Minister of Health and the patient organisation community. The Council's activity is another stage in the development of cooperation between the Ministry of Health and patient organisations. The Council is to give a formal framework to this cooperation, it is to place patient organisations even more firmly in the decision-making processes concerning systemic solutions in health care, it is also to strengthen the voice of patient groups in their relations with the government administration.

The Council's task in particular is to:

• coordinating the cooperation of patient organisations with the Minister;
• discussing systemic issues in health care forwarded by patient organisations;
• receiving proposals for legislative amendments to draft normative acts from patient organisations in order to develop common positions and present them to the Minister;
• encouraging the active participation of patient organisations in the legislative process;
• Coordinating, on the part of patient organisations, the pre-consultation and public consultation of draft normative acts and other government documents by the office serving the Minister;
• cooperation with other councils of patients' organisations, in particular those of the Patients' Ombudsman and the National Health Fund.

The Council can be approached by any non-governmental organisation acting for the benefit of patients with proposals for legislative changes, new solutions to systemic issues - excluding individual issues, including medicines. The role of the Council is also to collect opinions on proposals for legislative changes proposed by the minister responsible for health from patients' organisations and to represent a common, elaborated position. The Council is equipped with the competence to set up working groups, for which the Council will determine the rules of operation, composition and specific tasks within the Council's competence. The first working group established by the Council is the "Prevention Team", whose aim is to prepare a functional system of primary and secondary prevention financed from public funds and to ensure equal access to health prevention regardless of the socio-economic situation of citizens.

Candidates for the Council were nominated by non-governmental organisations that, among other things, operate in the field of health care; have a nationwide reach; have been registered for at least five years; and have made a written declaration that their activities are guided by the values set out in the Charter of Good Governance Principles of Patient Organisations. The Council, which was appointed for its first term, was composed of 15 persons proposed by the largest national patient organisations. A total of 55 applications were received during the recruitment process, out of which the following were elected to the Council:

1. Elżbieta Oleksiak - Polish Association of the Blind;
2. Krystyna Wechmann - Federation of Amazon Associations;
3. Arkadiusz Nowak - Institute for Patients' Rights and Health Education - Chair;
4. Joanna Pietrusiewicz - Birth by Humanity Foundation;
5. Jacek Hołub - Polish Society for the Support of People with Inflammatory Bowel Diseases "J-elita";
6. Stanisław Maćkowiak - Federation of Polish Patients;
7. Aleksandra Rudnicka - SANITAS Cancer Association;
8. Paweł Wójtowicz - MATIO Foundation for Helping Families and Patients with Cystic Fibrosis;
9. Magdalena Kolodziej - MY Patients Foundation - vice-chair;
10. Urszula Jaworska - Urszula Jaworska Foundation;
11. Anna Śliwińska - Polish Diabetes Association;
12. Piotr Fonrobert - Polish Coalition of Oncology Patients and the Association for GIST Patients;
13. Małgorzata Durka - Union of Associations Coalition 'Na Pomoc Niesamodzielnym';
14. Piotr Dąbrowiecki - Polish Federation of Asthma, Allergy and COPD Associations;
15. Dorota Korycinska - OnkoCafe-Razem lepiej Foundation, Alivia - Oncology Foundation, 'Beat Cancer' Foundation, Blue Butterfly Ovarian Cancer Association, Alba Julia Neurofibromatosis Association Poland, OmeaLife Foundation.

The inaugural meeting of the Council of Patient Organisations was held on 27 April 2022 and since then the Council has met six times and developed several key positions from a patient perspective, including:

1. Position statement of the Council of Patients' Organisations under the Minister for Health on the occasion of "World No Tobacco Day" adopted at its meeting on 18 May 2022 with the following content:

We appreciate all the efforts of institutions working in health care as well as in other areas of society, which with for the sake of the well-being and health of Poles undertake activities aimed at reducing the use of nicotine products. At the same time, the Council recommends that the Minister of Health develop a strategy aimed at: 

1. Maximum achievable reduction of nicotinism in social life,
2. The protection of minors from addiction to nicotine and raising the age of eligibility to purchase nicotine products from 18 to 21,
3. Increase access to specialised treatment based on current medical knowledge (including psychotherapy, specialised counselling, health-promoting education, pharmacotherapy), in line with the provisions of the World Health Organisation Framework Convention on Tobacco Control (FCTC),
4. Impose levies on tobacco products analogous to a 'sales tax on alcohol products' or a 'sugar tax'.

The authors of this position paper are confronted on a daily basis with the suffering of people suffering from cancers, which in very many cases are the result of long-term tobacco use. The most common cancer in Poland is lung cancer, which is also characterised by a high mortality rate and is often detected only at high stages of development. According to the National Cancer Registry, for more than 10 years it has been the first cause of death among women and the second among men. Cigarette smoking is also a factor that exacerbates complications with severe COVID-19 and contributes to premature deaths worldwide from it. The last two years of the pandemic have hit not only health care, but society as a whole hard. The public discussion on vaccination has highlighted as never before the value and importance of preventive health care in the life of every Pole. Appreciating this fact, we should make the issue of smoking prevention a permanent part of the public discourse and permanently resonate with educational programmes for the youngest, the approach to health of compulsive smokers and also become a point of reference in the precise regulation of the status of all substitutes for traditional cigarettes.

This is what strategy, which the Council believes should be developed by the Minister of Health in cooperation with other ministries and civil society organisations.

2. Position of the Council of Patient Organisations to the Minister responsible for Health on the draft Law on Quality in Healthcare and Patient Safety of 14 June 2022, adopted at its meeting of 29 June 2022 with the following content:

The Council of Patients' Organisations to the Minister responsible for health matters, hereinafter referred to as ROP MZ welcomes the inclusion of some of the changes reported during the public consultation in the title bill. In order to ensure that the Act is fully in line with patients' expectations, the Council makes the following comments:

1. The Act narrows both the quality and patient safety criteria to inpatient treatment.

We request that the quality and safety monitoring system be extended to the entire health care system in Poland, without being narrowed down to hospital treatment. Coordination of healthcare requires integrated standardisation of quality and safety of all medical entities. We request that the obligatory deadlines be specified in the Act, after which the Act on quality and patient safety will gradually cover the entire public health care system in Poland.

2. The MZ ROP requests the reinstatement of the following point in Article 4: "compensation benefit system". The point in the proposed wording was in the original version of the draft.
3. According to the MZ ROP, the amount of fees for filing a compensation application and the appeals procedure can be a serious financial barrier for some potential applicants. The cost of submitting both applications is equivalent to almost half of the current social pension (PLN 1147.2 net as of March 2022). We call for mechanisms to be put in place to exempt those on the lowest incomes and in other justified cases.
4. Pursuant to Article.71g(1), the applicant is a party to the proceedings. We request that a professional attorney designated by the applicant be admitted to the compensation proceedings or, alternatively, that relatives of the applicant be allowed to act as attorneys as defined in the Act.
5. We call for a representative of patient organisations to be appointed to the Medical Records Council as an observer.

In the opinion of the ROP of the MZ, no councils with a direct or indirect impact on patients should be created without the participation of the representation of this community.

6. An effective and efficient no-fault system without adjudication of guilt and the creation of a Medical Incident Compensation Fund is in the interest of patients and its implementation should ensure quality treatment and patient safety.

According to the explanatory memorandum, contained in the draft of the law in question:

"The bill provides for the introduction of regulations for the protection of medical staff in relation to the reporting of an adverse event, which is intended to encourage staff to disclose as many adverse events as possible, without fear of possible sanctions and repressive action related to this, and to influence the development of a culture of safety within patient care.

Staff who report an adverse event should therefore not be subject, with certain exceptions, to such adverse actions as termination of their contract or unfavourable changes to their working conditions and pay. A person who reports an adverse event before the criminal prosecution authority becomes aware of the offence will also not be subject to punishment for an unintentional offence as defined in Article 155, Article 156 § 2, Article 157 § 3, Article 157a or Article 160 § 3 of the Act of 6 June 1997. - Penal Code (Journal of Laws 2021, item 2345, as amended), unless it refers to such morally reprehensible situations as being under the influence of alcohol or an intoxicant".

The Council of Patients' Organisations is positive about the proposed solutions provided for in the draft Act in this respect. The ROP of the MZ expresses its satisfaction with the inclusion of representatives of two social organisations acting for the benefit of patients' rights in the membership of the Accreditation Council.

3. Position of the Council of Patients' Organisations to the Minister responsible for health on the draft law on certain health professions of 20 January 2022 adopted at its meeting of 13 July 2022 with the following content:

The Council of Patients' Organisations under the Minister responsible for health matters, hereinafter referred to as the ROP of the Ministry of Health, appreciates the plan to regulate the conditions and principles of medical professions, which have not been covered by statutory regulations so far. The proposed provisions may have a direct positive impact on the quality of services provided to patients.

The MZ ROP provides the following comments on the law:

1. By regulating the conditions and principles for practising the medical professions listed in the Act, it is hoped that a standard of training will be introduced and ultimately that a similar level and quality of patient care will be provided throughout the country and that the health safety of patients will be ensured. A full assessment of this solution will be possible after reading the regulation specifying the qualification requirements necessary to practice a medical profession and the regulation specifying the list of professional activities which medical practitioners are authorised to perform.
2. The draft's introduction of a register of the medical professions listed in the Act may make it possible to carry out supervision of the proper practice of the medical profession, as well as to obtain information on the current number of medical practitioners, the way in which the profession is practised.
3. The obligation of continuing professional development introduced in the Act is a solution that has a direct, positive impact on the quality of the services provided and their delivery in accordance with the latest medical knowledge. The MZ ROP considers this provision to be one of the key ones.
4. The MZ ROP requests further work on the law in question with regard to the provisions regulating the issues relating to the professional liability of medical practitioners. Additional analysis and consultation are required on the following issues:
   1. the location of the Professional Responsibility Commission - under the Minister of Health, the Patient Ombudsman or perhaps in a completely independent institution. The correct positioning of the Commission will have a direct bearing on the efficiency and objectivity of its work;
   2. application fees - the application fee can be a financial barrier for some potential applicants - we call for mechanisms to be put in place to waive fees for those on the lowest incomes;
   3. the possibility of extending the list of health professions contained in Article 1(1) of the draft Bill to include additional professions that were raised by patient organisations during the public consultation.
5. We request further work on this law with regard to the provisions of Article 13 on the application of patient rights by the medical professional. The manner and scope of the provisions in this aspect require further analysis.

The most recent document developed by the Council was the adoption of basic requirements for representatives of organisations whose statutory objective is to protect patients' rights, in particular, those referred to in Article 47(1)(10a) of the Act of 6 November 2008 on Patients' Rights and Patients' Rights Ombudsman (Journal of Laws of 2020, except 849, 1655, 1696 and of 2022, item 64) who are candidates to be members of the Supreme Bioethics Committee for Clinical Research with the following wording:

Non-governmental organisations (NGOs) whose statutory objective is the protection of patients' rights shall select candidates for members of the Supreme Bioethics Committee for Clinical Trials from among their members with a university degree or a scientific degree, preferably in one of the following disciplines: humanities, medical and health sciences; sciences and natural sciences; theology, social sciences, engineering and technology.

Desired competencies of a candidate for membership of the Superior Bioethics Committee for Clinical Trials:

1. The candidate should have a minimum of 5 years' experience in patient advocacy in a non-governmental organisation that aims to protect patients' rights.
2. Have a general knowledge of clinical trials (knowledge of related legislation), the role of clinical trials, the purpose of clinical trials, the principles of developing research protocols, informed consent statements, human and patient rights, the recruitment process.
3. Ability to understand and give opinions on medico-legal documents, including those written in English.
4. Knowledge of the functioning of the health care system in Poland, including the process of reimbursement of medicines, provision of medical services, basket of guaranteed benefits.
5. Familiarity with the protection of personal data, including biometric data.
6. Knowledge of the ethics of medical and biological research in particular how to handle biological material.
7. Knowledge of issues in research methodology.

All the minutes of the meetings, adopted positions and guidelines developed by the Council of Patients' Organisations under the Minister of Health can be consulted on the website of the Ministry of Health under the direct link https://www.gov.pl/web/zdrowie/rada-organizacji-pacjentow 

Igor Grzesiak - Institute for Patients' Rights and Health Education

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