Political Interests and Private Healthcare Lobby Collude to Stifle Patients’ Rights in Karnataka

The Karnataka government enacted the Karnataka Private Medical Establishments (KPME) Act in 2007 with the legislative intent of registering and monitoring the private medical establishments (PMEs). However, the act was plagued by poor implementation with only about 50% of the PMEs being registered since its inception. Recent investigations (Xavier et al 2016) and media reports on unethical practices in the private healthcare sector forced the government to take steps to bring in amendments to this act. With the intent of making the act “citizen-centric” and to “protect welfare of citizens,” the government constituted a committee led by Justice (Retd) Vikramjit Sen to provide recommendations for amendments to the KPME Act. 

Karnataka is the second state after West Bengal to have undertaken such an amendment in the recent past. With growing public resentment and anger against what is seen as greed and profiteering by the private hospitals on one hand, and blanket opposition to the bill from private hospitals on the other, we see a pitched battle ahead in Karnataka. In this context it is important to examine the various provisions in the KPME (Amendment) Bill 2017 and understand its implications for both citizens as well as private hospitals. 

KPME (Amendment) Bill 2017

The government introduced the Karnataka Private Medical Establishments (Amendments) Bill 2017 in the assembly on 13 June 2017. The bill focuses only on private hospitals as the principal act and its salient features include a charter of patient rights, regulation of cost, setting up district-level grievance redressal committees headed by the Zilla Panchayat Chief Executive Officer (ZP CEO) with powers of the civil court. The act also prohibits private hospitals from withholding dead bodies against payment of dues and demanding advance payment in medical emergencies.

Continued Focus on the PMEs as in the Principal Act 

While the focus of the legislation is on private medical establishments, there continues to be an intense pressure on the government to include the government healthcare system into the act.  Justice (Retd) Sen Committee which was formed, in fact, had several recommendations for such an inclusion. Doctors and their associations opposing the amendment bill have made this a rallying point saying that this is discriminatory. It should be noted that the legislative intent of the principal act, that is the Karnataka “Private” Medical Establishments Act, was to register and regulate private hospitals and not monitor the government healthcare system. The government hospitals and health centres, just like other government establishments, function as part of the constitutional mandate in public interest to provide preventive/promotive and curative healthcare services along with the control of epidemics, surveillance and disaster management, and relief and rehabilitation. The public health system functions under several oversight mechanisms such as Arogya Raksha Samitis, Vigilance Cell, Lokayukta, Civil Service Rules and so on which need to be strengthened for their effectiveness. Therefore, what the government system needs is not yet another law, but political will and commitment to invest more funds and resources so as to strengthen it meaningfully. 

No Separate Dedicated Architecture to Implement the Act

In the principal act, there was a District Regulatory Authority (DRA) headed by the Deputy Commissioner (DC) along with the District Health Officer (DHO) and the Indian Medical Association (IMA) as members. The DRA was empowered to form local committees to conduct inspections, act on complaints, and so on. Lack of oversight from a state-level body and dependence on the district health officer and his team for implementation were among the causes for poor enforcement of the act. Therefore, it was hoped that the bill will provide for setting up a separate regulatory and monitoring authority at the state and district levels with dedicated, fulltime officers. In the absence of such a crucial element in the bill, doubts about its effective enforcement continue to remain. 
Secondly, the DRA will include representation not only from the IMA as in the principal act but also representatives from the state Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) professional body. This, in effect, will dilute the very purpose of the regulatory authority and compromise its function due to conflict of interest. 

Cost Regulation

The bill provides for fixing of rates in the PMEs which is a bold and progressive step. With 70% of healthcare being provided by the private health sector, this would go a long way to bring down out of pocket expenses in healthcare.  

Section 9 of the principal act provides for the constitution of the expert committee to classify PMEs and set standards for each type of PME. Amendment to Section 9 in the bill suggests inclusion of non-official members and stakeholders whose numbers “shall not exceed one-third of the total members.” The new Section 9A of the bill describes the functions of the expert committee as classification of the PMEs, laying down of minimum standards, and fixing the costs of procedures. In other words, the bill provides for representation of PMEs in the expert committee, thereby providing for an inclusive procedure involving the PMEs themselves on these crucial aspects of regulation. However, the bill would have to go a step further to ensure that even among the PMEs there is adequate representation of the small/medium PMEs to ensure that the rates fixed are not skewed in favour of large/corporate hospitals. The bill also needs to be more specific about a rational, scientific formula to arrive at the rates. For instance, such a formula would have to factor in the type of PME, its size, and its geographic location. Importantly, the bill has to ensure that costs of core treatment aspects (such as surgical procedures, tests and diagnostics, implants, consultation, and nursing charges) are capped based on the rational formula, while those related to comfort and luxury (such as type of ward and other facilities) are not. These charges would have to be separately listed, displayed, and billed so that patients are able to make informed choices. Such a formula would prevent cost escalation which seems to be a predominant worry of the small/medium PMEs. 

Grievance Redressal Mechanism

The bill provides for setting up district and metropolitan grievance redressal committees headed by the ZP CEO with the Superintendent of Police (SP), one representative from a private hospital, a district surgeon,^[1] one public prosecutor and one female representative as members. The state-level appellate body is headed by the health commissioner with Director of Health and Family Welfare and Director of AYUSH services as members. 

While this marks the first step towards providing an exclusive forum that will hear complaints against PMEs in an integrated manner, in terms of being located closer to the people it is woefully inadequate. Having separate mechanisms for patient grievances and for PMEs is important. The redressal mechanism for hearing patient grievances and patient rights violations could be modelled after multi-member tribunals at the district and state levels, along the lines of what is provided in the West Bengal Clinical Establishments Act (WBCEA), 2017. Without an exclusive, dedicated forum for grievance redressal at the district and state levels, justice for those who suffer violations will continue to be out of reach. 

Patient Rights Charter

The proposed patient rights charter includes various entitlements to patients such as right to care without discrimination, confidentiality and dignity, information, preferences (second opinion), and redressal. Among others things, the charter does not include the right to protection against clinical trials, which is a crucial right. Several hospitals identify themselves as “research centres” and seek blanket consent for all interventions including using blood, tissue, and other body products for “clinical research purpose,” making it impossible for patients to tell whether they are being subjected to “research” or being given treatment as per established protocol. Though not comprehensive, inclusion of the patient rights charter marks a beginning for legalising patient rights. 

Penalties and Punishments 

Compared to the WBCEA, there are no serious prosecution related clauses in the KPME (Amendment) Bill. For instance, Section 34 of the WBCEA provides for imprisonment up to three years and prosecution under the Indian Penal Code if the PME “causes death or injury of patient or service recipients due to negligence” and imposition of penalties up to ₹10 lakh. It lays down 24 conditions that are to be fulfilled by all PMEs which include, among other things, e-prescription, electronic records, public grievance cell in every facility, free services to 10% of inpatient department and 20% of outpatient department, protection of patient rights, and so on. On the contrary, the KPME (Amendment) Bill does not have such an exhaustive list of preconditions and the maximum penalty in the bill is ₹5 lakh. Doctors from PMEs took up cudgels against the government for increasing the jail term to five years and accused it of criminalising them. Even as the government tabled the bill in the assembly, jail term was reversed to what was in the Principal Act (6 months to 3 years for running a private hospital without registration).

It is important to note that the government enacted the Karnataka Prohibition of Violence Against Medicare Service Personnel and Damage to Property in Medicare Service Institutions Act 2009 to protect medical establishments and personnel against attack by patients.  By the same token, certain acts of wilful medical misconduct, medical malpractices and fraud by PMEs should be made criminally cognisable under the bill, as they do threaten patient safety, survival, and well-being.

What Is the Bill Silent On? 

There are certain other crucial elements that need to be considered for inclusion in the bill.  For instance, the bill should contain provisions that ensure that PMEs adhere to and are accountable for good clinical ethical practices. Specifically, the bill should prohibit PMEs from fixing targets (for surgeries, procedures, investigations, and any other service) for its doctor employees. Similarly, there should be provisions for rational, ethical prescription practices. Most importantly, the bill should prohibit cuts and commissions for referrals and prescriptions which is currently a normalised practice within the medical fraternity. It is important to note that the Government of Maharashtra has recently set up a committee to draft a law to prohibit and make the “cuts and commission” practice by PMEs an offence. While the Indian Medical Council Act, 1956 prohibits soliciting of patients by doctors, presently there is no regulation on “advertising” by PMEs. The present bill should prohibit advertising of services by PMEs. This would include billboards, hoardings in public places, distribution of referral slips, and electronic advertising on social media platforms (as also through e-mail, SMS, WhatsApp). In the present age of big data and surveillance, the bill should include provisions to safeguard against commercial use/sale of patient data by PMEs. 

Contested Arena of PME Regulation

With the rise of private healthcare, those from the standpoint of neo-liberal economics (Bloom et al 2009) as well as those from health rights and equity perspective (Mackintosh and Koivusalo 2005) have proposed regulation of private healthcare services.  

The Karnataka government’s intention behind proposing amendments to the KPME Act was to strengthen existing regulatory provisions in the act while also adding new sections to protect citizen’s interests. In sum, the bill in its intent is pro-people and is a progressive first step towards increasing regulation and accountability of the PMEs. In terms of content, the bill is definitely not draconian as it is being made out to be. In fact, there is substantial opportunity for the PMEs to be part of the regulatory process which, in many ways, defeats the very purpose of regulation. 

The resistance to this process and subsequent manipulations by the PMEs started within the Justice Sen Committee itself, and was reflected in the Committee’s recommendations that favoured private sector interests (Vijayakumar et al 2017). This resistance against regulation is neither new nor unexpected. Doctors in India have resisted regulatory measures starting with their opposition to Consumer Protection Act, 1986 and more recently to the Clinical Establishment Act, 2010 (Nagral 1992; Srinivasan 2013).

PMEs in Karnataka opposed not only the proposed increase in jail term from six months to three years and cost regulation, but also the inclusion of grievance redressal mechanism, patient rights charter, and non-inclusion of public health system. All PMEs from small/medium to corporate hospitals jointly held a protest against the bill. Yet, representatives of the small and medium hospitals contest that the bill will aid corporatisation of healthcare and that they will be forced to close down. If this were true, then one wonders why the PMEs insisted that the public health system should also be included under the bill.  At present, the PMEs seem to be in no mood to engage with the bill in a constructive manner. They seem to be rejecting the idea of regulation in toto. 

Historic Tabling and Assembly Debate 

The discussion in the Karnataka assembly on the KPME (Amendment) Bill on 20 June 2017 was a historic event. Members of the legislative assembly (across party lines) welcomed the bill as being pro-poor and pro-citizens, but were concerned about its consequences on doctors. The health minister’s 90-minute introductory speech providing evidence for the need for regulation to curtail malpractices in PMEs was followed by a nearly six-hour long debate on the bill. Finally, it was referred to the Joint Select Committee^[2] with a directive to revert within five weeks. Referral to the Joint Select Committee is an indicator of the politically sensitive nature of the issue and perhaps the legislators’ reluctance to take a stand in the election year. 

In Conclusion 

By pursuing healthcare policies that are detrimental to the public health system, successive governments are culpable of pushing citizens to seek care in the largely exploitative private health sector. The present debate around the KPME (Amendment) Bill questions such a pro-private policy environment that is taking a toll on the public health system and patients’ lives. The regulatory vaccum which fostered the unhindered growth of the profiteering private sector in the first place is also responsible today for patient rights violations. Be it the corrupt public health system or the profiteering private health sector, driving the healthcare crises in the country is the medical fraternity’s resistance to regulation and an erosion of their professional integrity. The fact that potential violators are the ones who act as the jury and that there is no recourse to justice has fuelled a deadly mix of anxiety, anger, and helplessness among patients and their families, leading to instances of attacks on doctors and hospitals. Regulation is therefore crucial to de-escalate tensions between patients and doctors. 

The KPME (Amendment) Bill 2017 is a progressive first step to increase the accountability of the private health sector. However, the Karnataka government clearly cannot stop there. It has to increase its spending on the public health system and ensure that scarce resources are not siphoned off to private hospitals through the myriad government health insurance schemes. The existing accountability mechanisms within the public health system have to be meaningfully strengthened to ensure that citizens return to seeking care in government facilities.

Postscript

The Joint Select Committee held a hearing on 23 August 2017 in which several citizens’ groups and private hospital associations made their submissions. Based on these submissions and deliberations within, the Joint Select Committee revised the bill. Just before the winter session of the Karanataka assembly in November 2017, the IMA and private hospital owners’ associations orchestrated a massive misinformation campaign about the provisions in the bill through social media and WhatsApp and led a sit-in protest against tabling of the KPME Bill 2017. The IMA’s deliberate misinformation campaign shifted the focus from hospitals to doctors and raised non-existent issues such as jail term to create mob panic that prevented discussions of any genuine concerns. In fact, several doctors participating in this protest admitted openly that they had not read the bill but had joined the protest based on WhatsApp messages from the IMA. Leaders of the opposition parties exposed their affinity for the private health lobby by making statements in support of private hospital owners, but none in support of protection of patient rights. It was only after intervention of the High Court that a section of the private hospital owners withdrew their protest. The government had so far heard all stakeholders’ concerns in a truly democratic manner. At this juncture, however, the government held unilateral decisions with the private hospital owners and restricted cost regulation to government health insurance schemes. This measure is neither new nor comprehensive. Secondly, it brought in provisions related to grievances and complaints that will act as deterrents to patients who wish to file complaints. The KPME Bill 2017 with these changes was subsequently passed in both houses of the state legislature.

The private health sector has repeatedly demonstrated its profiteering nature. Both the central and state governments have pursued healthcare policies that push citizens to seek care in private sector, thus increasing their dependency on the latter. The IMA-led protest in Karnataka with support of opposition parties leaves citizens in no doubt as to whose interests the private health sector will privilege. It also exposed the blatant collusion of vested political interests with the business interest of the private hospital lobby that poses a threat not only to citizens’ rights, but to the functioning of democracy itself.