Sir,
The Indian Medical Association (IMA) is the sole representative body of doctors practicing modern system of medicine in the country and is deeply concerned at the manner and method in which the Clinical Establishments (Registration & Regulation) Bill, 2010 has been passed by the Parliament without considering the several issues raised by the IMA which, to our mind, raise several critical concerns with the provisions of the statute and the consequences thereof. The IMA had forwarded detailed comments to the Government in respect of the Clinical Establishment Bill, 2007, which was reintroduced in the Lok Sabha as Clinical Establishment Bill, 2010.
You will recall that the IMA was entrusted with the responsibility of reviewing the existing Clinical Establishment Acts in various states and a detailed report was duly submitted to the government. The IMA has been attending various meetings of the National Council for Clinical Establishments under the chairmanship of the Director General of Health Services. The views of the IMA against the Clinical Establishment Act have been expressed at these and other platforms from time to time since the idea for the Act was mooted.
However, the considerable haste with which the Clinical Establishment Bill has been passed by both houses of the Parliament and received the assent of Her Excellency The President of India, and without an adequate debate on the issues raised by the IMA have constrained us to convey through this representation the collective views of all the practitioners of modern medicine in India with a specific request to look into the following constitutional and legal and other issues regarding the Clinical Establishment Act before the same is notified.
1. As per the Preamble, this is an Act “to provide for the registration and regulation of clinical establishments with a view to prescribe minimum standards of facilities and services which may be provided by them so that mandate of article 47 of the Constitution for improvement in public health may be achieved”.
2. There are three basic flaws here.
a. FIRSLY, the Act does not fall within the purview of Article 47, which concerns, inter alia, the “raising of the level of nutrition and the standard of living of its people and the improvement of public health” as among the primary duties of the State. As such, ‘public health’ as understood by the Constitutional framers was rather in the context of a healthy population and measures aimed at achieving that goal rather than aimed at the practice of medicine and/or clinical establishments which, in the strict sense, are merely concerned with curative health which is distinct and entirely different from public health.
b. SECONDLY, there is no rational nexus between the objective the Act seeks to achieve and the methodology sought to be adopted thereunder. The approach to “improvement in public health” does not lie through registration and regulation of clinical establishments which, by definition, essentially provide clinical and curative services. Rather, the approach has to be a preventive approach as per settled principles of health science.
c. THIRDLY, Article 47 refers to “improvement of public health”. Improvement does not mean placing restrictions on the working and functioning of healthcare providers but rather facilitating an atmosphere which would encourage health care professionals to perform their Hippocritical obligations unhindered by the risk of over-regulation and a bloated administrative mechanism. The consequences of over regulation and the license raj pre-liberalisation ought to be a stark reminder of the perils of such a move.
3. It is clear from a reading of the preamble and the provisions of the Act that the stated purpose and ultimate impact of the act will be to place restrictions upon the fundamental right of the medical practitioners to practice their profession within the meaning of Article 19(1)(g). As a matter of fact, it is odd that such restrictions on Fundamental Rights are sought to be imposed under Directive Principles of State Policy particularly when there appears a clear disconnect between the objectives and the approach as abovementioned.
4. A particularly disconcerting aspect is the definition of an ‘emergency medical condition’ in Section 2(d) of the Act, which is a new addition to the erstwhile Clinical Establishment Bill, 2007. The same places in the judicial domain what strictly and squarely belongs to the medical domain and is contrary to the dicta of the Supreme Court of India which has clearly laid down that in such matters, the profession is the best judge and has encouraged referral of like issues to medical boards for assistance in judicial matters. For similar reasons, we submit that neither the judiciary nor the legislature would be adequately equipped to adjudicate upon whether or not a particular medical condition is an emergency medical condition or not. As such, the statute is clearly liable to be interdicted for vagueness. Reference may be had to the various decisions of the Hon’ble Supreme Court which have repeatedly cautioned against taking a stand in medical matters and have, on the contrary, provided stringent safeguards against arbitrary exercise of judicial or administrative power in medical matters.
6. Similarly, section 2(o) seeks to legislate regarding what is essentially a medical phenomenon, namely, ‘stabilisation’ of the condition of the patient and mandates that the patient should not be transferred till his/her condition has been ‘stabilised’. There is however, no clarity in whether what the meaning of the word ‘stabilised’ is and more importantly, who would be responsible for the costs incurred in the same. The definition also fails to note that not all clinical establishments may have the necessary infrastructure to provide the kind of specialised assistance that may need to be provided to patients in critical conditions and further, that they would be better served by being diverted to a hospital with the necessary facilities. However, this very action, which is in the best interests of the patient, could expose the establishment to the risk of substantial penalty. We submit that this clause squarely treads upon the medical domain which cannot be left to judicial or legislative interpretation particularly when such evaluation is to be done post facto without the benefit of the actual ground reality at the time when the patient arrives at the clinical establishment in a critical condition. You will recall that the Supreme Court in IMA v. V.P. Shantha has clearly laid down that the medical profession provides services under a contract for service. Such a contract is between the patient and the doctor. The services provided under such contract are already justiciable, inter alia, under the law of contract, the law of tort, the Consumer Protection Act, 1986, and the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002. It is an unwarranted intrusion on professional independence of the medical professionals which will lead to flood gates of litigation and will, ultimately, prove detrimental to the society and be counter-productive to the very interest that it seeks to promote.
7. Moreover, given that the obligation to provide emergency medical services is imposed by law, there is no rationale basis why similar establishments falling within the fold of the armed forces are exempt from the same.
8. Section 3(2) of the Act provides for a dismally low representation of modern medicine / allopathic doctors in the National Council even though they form the bulk of those providing services through various clinical establishments such as hospitals, laboratories and blood banks etc. The majority of the clinical establishments comprises of hospitals and nursing homes. It is clear from available data that the number of hospital beds under the allopathic system is more than ten times the number in case of non-allopathic systems. It is, therefore, submitted that, in all fairness, there is a need to rework the representation as per the existing proportionality on ground. Similar comments apply to section 8(2) as regards the state council.
9. Again, though the Act is meant for the regulation of clinical establishments in the private sector, it is anomalous that there is no provision for the representation of the private sector at all, in the National Council as envisaged in Sec 3 of the Act. This needs to be appropriately balanced particularly when it seeks to impose obligations of a far reaching nature and which are backed by penal consequences, in the event of non-compliance.
10. Sec 10 (1) of the Act providing for setting up of the District Registering Authority, leaves it discretionary for the Central government to prescribe the qualifications of the members. We submit that this is another instance of excessive delegation that appears to be writ large over the Act and needs urgent rectification. It is submitted that the inclusion of a medical specialist and a legal expert should be made mandatory on the lines of other similar legislations e.g. Section 17(6) of the Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 and Section 21 of the Delhi Medical Council Act, 1997.
11. Section 12 (1) (ii) of the Act is another instance of excessive regulation which ought to be within the domain of the owner of the establishment in as much as it takes away the freedom of the owner of the establishment to employ the number and type of personnel as he may think appropriate and thereby violates his fundamental right to run his establishment as he deems appropriate within existing laws.
12. In reference to Section 12 (2) of the Act, it is an absolute must that before notifying the Act, the government should create an appropriate mechanism for payment of compensation to the clinical establishments for services rendered particularly given the nature of the obligations imposed. The very fact that there is no clarity on the nature of equipment required to ‘stabilise’ a patient and that an establishment seeking registration, which is mandatory, has to undertake to make available the required medical examination and treatment to any individual without regard to the primary issue as to whether the same would be in the patient’s best interest, clearly demonstrates the grave lacunae in the Act which needs urgent attention and remedying. By way of example, there is no discretion vested in an establishment as to the nature of care to be provided to a patient with an emergency condition and the obligation is to retain the patient till his/her condition is stabilised. The Act clearly fails to recognise that this imposes a significantly high burden on the average clinical establishment which may have neither the expertise nor the resources to provide the nature of specialised care that a patient may require and fails to address the question of how an establishment would be compensated for the same.
13. The IMA is also deeply concerned about the wide nature of discretion vested in the authorities under Section 32 to cancel the Registration of an establishment in certain cases, which we believe is tantamount to double jeopardy. Moreover, the mere grant of a show cause notice to our mind would not, in any manner, dilute the draconian nature of the provision and the grave possibilities of its misuse. We submit that this aspect too, requires a serious reconsideration.
14. Section 49 is against the fundamental right granted under article 19(1)(g) of the Constitution. It gives wide, unbridled and uncontrolled power to the district authority, headed by the District Collector, “to issue such directions, …………. ……………for the proper functioning of clinical establishments and such directions shall be binding”. We are unable to comprehend the need for such a wide, unfettered conferment of discretion on executive authorities, particularly given the existing regulatory regime. Moreover, when the Act lays down a comprehensive set of guidelines for imposition of penalties which are significantly deterrent, it is illogical, irrational and uncalled for to give to the authorities any further arbitrary power to issue any directions which may be impractical or whimsical or even impossible, and to make those directions binding without any provision for a prior show cause notice and without defining the ambit, nature and justification for the same.
15. As mentioned hereinabove, the Act is replete with instances of excessive delegation which would only serve to deter the growth of clinical establishments and prove to be a fetter to their functioning rather than severing any credible and/or laudable purpose. This is likely to result in bureaucratic red- tapism and motivated and colourable exercise of administrative power. In plain words, it is likely to further promote corruption and to subjugate the already overburdened private healthcare delivery system to government control.
16. In conclusion, we submit that the entire autonomy of functioning of the private healthcare sector has been taken away by the Act at a time when the private sector shoulders the major responsibility of healthcare in
India as per official data. The very reason for such majority role is the freedom, flexibility, innovation, enterprise and efficiency of the private sector as compared to the government sector. The government, instead of improving its own functioning, has sought to impose unwarranted restrictions on the private healthcare sector under the guise of providing a regulatory mechanism. The importance of the private health sector has been duly emphasised in the National Health Policy.
17. The undue restrictions and threats faced by the medical profession have already resulted in a situation when, as per the CBSE data over last 7-8 years, the proportion of school students opting for the biology / medical stream has been steadily declining. The present Act would pose another major impediment in the functioning of the private health sector unless the above concerns are addressed.
18.
This Act would act as a disincentive for the establishment and growth of private hospitals and nursing homes which form the backbone of medical care in
India in the absence of adequate Government facilities for the same. As a matter of fact, the need for promoting medical tourism through private hospitals has been duly emphasized in the national health policy. It is submitted that this Act will prove to be an Anti People Act because it will hamper the functioning of hospitals and nursing homes on which the public depends for health care services.
19. Therefore, in the national and public interest, the Indian Medical Association hereby requests that the points raised above may be seriously considered at an appropriate level before notifying the Clinical Establishments Act, 2010.
Yours Sincerely,
(Dr.Dharam Prakash) (Dr.Vinay Aggarwal) (Dr.D.R.Rai)
Hony. Secy. Genl National President (Elect) Hony.Secy.,Genl. (Elect)
Copy to:
The Hon’ble Minister of Health and Family Welfare
Secretary, Ministry of Law
--Cabinet Secretary
--PMO
--President of
India--Eminent legal luminaries:
* Sh. Ram Jethmalani
* Sh. Kapil Sibal
* Sh. P C Chidambaram
* Sh. Ravi Shankar Prasad
Draft memorandum
To
The Hon. Member of Parliament /District Collector
Dear Sir/Madam,
Indian Medical Association is the largest professional body of modern medicine doctors in India. It has a membership of 1,98,000 spread over 1600 local branches and 27 state branches. The membership encompasses both Government and Private doctors; medical college teachers and young graduates; specialists and general practitioners. IMA brings to your attention the following facts:
1. Government of India by an ordinance dissolved Medical Council of India in 2010.This brought in a board of Governors replacing a federal and democratic MCI. Government of India is now planning to create a high arching body including non medical technical and management education obliterating the unique identity of medical profession. Government has no mandate to alter institutions in a way that could interfere with the constitutional guarantee to life. We, a) condemn the dissolution of MCI
b) demand that the nominated Board of Governors of MCI be dismissed forthwith.
c) demand restoration of MCI to its original character and form.
2. The second issue of national importance is the back door attempt to impose a 3 ½ year modern medicine course on the nation under the guise of rural health. Government of India is going ahead with establishment of medical schools in district hospitals to churn out half baked Bachelor of Rural Health Care (BRHC) graduates. While modern medicine is experiencing a knowledge explosion and when even a 5 ½ years MBBS course is insufficient, Government of India thinks of a 3 ½ year medical course in its wisdom. Compromised education and training in institutions where infrastructure and faculties have been compromised will compromise the health of villagers. And why should the villagers be accorded substandard care? IMA urges the Government to stop this ill advised move even at this late stage. We request the Government to consider other options to produce regular MBBS graduates with rural medical colleges with rural quota or 1 year compulsory
rural service to MBBS medical graduate instead. The Government can also Consider incentives like preference in post graduate selection and special rural salary structure.
3. In its wisdom the Lok Sabha passed the Clinical Establishment (Registration and Regulation) Act 2010 to regulate the hospitals of this country without even a semblance of discussion. This law effectively brings in a license raj. Every clinic and hospital in this country has to renew its license once in three years. There are already more than 43 laws governing the hospitals. By imposing a license raj a vibrant health sector is being targeted.IMA is concerned about the negative impact on the health of the nation by such retrograde regulation. We demand
a) single window for all legislations on a hospital.
b) To do away with licensing.
c) provide for online registration and independent accreditation process.
We the members of Indian Medical Association express our anguish over the lackadaisical approach of Government of India over matters of great importance to the health of our people. We kindly request you to use your good offices to reflect our concern and demands to appropriate authorities. Thanking you,
Yours in the cause of medical profession,
