By- Sunil Nandraj
Firstly it is necessary to note that the framing of the Clinical Establishments (Registration and Regulation Act, 2010 (CEA 2010) was
necessitated since there has been practically no regulation for private clinical establishments in the country. This has been due to the
opposition by certain sections of the medical profession and owners of clinical establishments for any kind of accountability or transparency.
Many state governments were not able to push for enacting legislation regulating private clinical establishments. In Maharashtra, the Bombay Medico- Friends- Circle group which took the lead 15 years back by filing a PIL in the Bombay High court, not much progress has been achieved in the State. In the above context it was felt that having a central act, would put pressure on those state governments that do not have any legislation to adopt a central act and those States to modify their outdated & deficient existing acts regulating private providers. This seems to have been achieved to an extent.
In August 2010, the Parliament of India passed the ‘Clinical Establishments (Registration and Regulation) Act, 2010’, which came into force in March 2012. Through the CEA 2010, all private and public (excluding the armed forces) medical facilities (called clinical establishments), which cover all systems of medicine, laboratories & diagnostic centres and single doctor establishments, need to be registered. It is applicable in the States of Arunachal Pradesh, Sikkim, Mizoram, Himachal Pradesh and all Union Territories. The States that have adopted this act are Uttar Pradesh, Rajasthan, Bihar and Jharkhand. Maharashtra and other states are keen on adopting the CEA 2010. The central government is keen on pushing the State governments to adopt the central Act. Kerala & Tamil Nadu are keen on having their own Act in line with the CEA 2010. In Punjab and Gujarat, there is massive opposition for adopting or enacting similar legislations. Among the States & UTs the CEA 2010 is applicable and adopted the progress has been slow due to various reasons. In Himachal Pradesh and Sikkim the offline registration of clinical establishments is in progress. In the other States and UTs the governments are in the process of notifying the State / UT councils, the District Registration Authorities and the Rules under section 54 of the act. The National Informatics Centre has developed a web-based software for the implementation of the CEA 2010. (http://clinicalestablishments.nic.in/). The copies of the Act, Rules are available on this site.
The National Council, through multi stakeholder participation and a consultative process is presently in the process of categorization and classification of clinical establishments, determination of minimum standards, information to be collected from clinical establishments, determining the rates and charges to be charged among other aspects.
The salient features of the CEA 2010 are that there would be digital registry of all types of Clinical Establishments at National, State &
District level. All information provided by the clinical establishment would be available in the public domain. It would assist government in obtaining data from clinical establishments required for public health interventions including outbreak and disaster management among others. The provisional registration would be through self declaration, without any inspection. Permanent registration would be undertaken after categorization and determination of minimum standards within two years from the date of notification. Every clinical establishment needs to provide treatment “within the staff and facilities available” to stabilize the emergency medical condition of any individual brought to such establishment. Details of charges, facilities available should be prominently displayed at a conspicuous place by each establishment. Clinical Establishments shall charge the rates for procedures and services with in the range of rates determined by the Central Government from time to time in consultation with the State Governments.Compliance to Standard Treatment guidelines as may be issued by Central/State Govt. to be ensured by CEs.
There has been opposition and resistance from private providers, owners and the IMA for any efforts to adopt the CEA 2010 or enact similar legislations. Some of the concerns raised by them include:
The Act will lead to “license and inspector raj”; it is anti-people and curtails freedom of medical practice, and the penalties are harsh. Another reservation expressed is that the Act makes it obligatory for clinical establishments to provide treatment and stabilise patients who is brought in an “emergency medical condition. The standards prescribed are harsh and would lead to closure of single doctor clinics and small medical establishments and this will raise the costs of treatment for the general public.
The apprehensions and reservations voiced by them are unfounded and not based on clear reading of the provisions of the Act.
Firstly it needs to be stated that the registration of establishments is a process of applying to the District Registration Authority by providing details either by post, online or in-person. There is no inspection and the grant of registration to the establishment is time bound, so that no application remains unattended. There are provisions for appeal before the State /UT Council of Clinical Establishments. Regarding penalties the act has consciously not kept any provision for imprisonment, only monetary penalties, as the intention is to seek compliance with the provisions rather than taking punitive action. W ith regard to Standards being harsh it needs to be noted that presently there are no standards prescribed. As mentioned earlier the National Council is presently in the process of categorization of different types of clinical establishments and determining uniform minimum standards. It is ironic that IMA, which is represented in the National Council should make statements that the standards are harsh.
IMA along with the Quality Council of India has been engaged by the Union Ministry of Health and Family Welfare to
survey existing standards in clinical establishments in states where it is applicable. IMA would need to support its argument that minimum standards would lead to closure of clinical establishment and increase costs with evidence. The premise of the Act is that there are few clinical establishments that operate using standards of care, guidelines and protocols and monitoring of these in the country is deficient.
IMA’s refusal to accept this is contrary to the interests of patient care and public health. The IMA’s reservation that the medical profession is already governed by number of Acts through multiple regulating bodies is baseless. The CEA 2010 was passed by the parliament on the request of many state governments that did not have legislation for clinical establishments. The provisions of the Act, which mandates that every clinic must provide basic emergency care, is being opposed by the IMA. It is well known that private hospitals and clinics do not admit accident victims who require critical emergency care because it can lead to a medico-legal case, or the patient or their families will be unable to pay for the treatment costs or are uninsured. This malaise is widely prevalent.
Taking note of this, the Supreme Court of India as long back as 1989 passed a ruling [Parmanand Katara v. Union of India AIR 1989 SC 2039] that made it obligatory for all practitioners to provide emergency medical care. The Act reemphasizes the judgment. It states: clinical establishment shall undertake to provide within the staff and facilities available such medical examination and treatment as may be required to stabilise the emergency medical condition of any individual who comes or is brought to such clinical establishment.
Further there are concerns being voiced that concerned stakeholders (including consumer groups) have not been represented in the various bodies of the CEA 2010. It needs to be noted that the CEA 2010 has 3 institutional mechanisms ie: The National Council, State / UT council and the District Registration Authority and in each of the bodies there is representation from consumer groups and professional medical association or bodies.
The CEA 2010 is not a perfect act, it has many problems and issues that have not been covered. However one needs to remember that when enacting an act there are various pressures from various stakeholders. Secondly is there a perfect legislation that meets the needs of all interested stakeholders involved and finally do we keep debating and discussing and wait for a perfect legislation. It is crucial that the clinical establishments in the country are accountable and transparent which would greatly improve the quality of health care in our country.
Regulating the private clinical establishments is a long struggle and we have miles to go…….
The author has worked in FRCH, CEHAT, WHO and presently on a sabbatical and advisor to the MOHFW, GOI on regulation of
Clinical Establishments, however he writing this note in his personal capacity. (email [email protected])
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