BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                     AB 789


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          Date of Hearing:  May 5, 2015


                   ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS


                                Susan Bonilla, Chair


          AB 789  
          (Calderon) - As Amended April 22, 2015


          NOTE: This bill is double referred, and if passed by this  
          Committee, it will be referred to the Judiciary Committee.


          SUBJECT:  Contact lens sellers:  prohibited practices:  fines.


          SUMMARY:  Specifies that sellers of contact lenses are not  
          subject to a manufacturer's unilateral pricing policy (UPP) and  
          raises the minimum fine for violating the Nonresident Contact  
          Lens Seller Registration Act from $1,000 to $1,500.


          EXISTING LAW:


          1)Provides that the right to dispense, sell or furnish  
            prescription ophthalmic devices at retail or to the person  
            named in a prescription is limited exclusively to licensed  
            physicians and surgeons, licensed optometrists, and registered  
            dispensing opticians, except as provided in the Nonresident  
            Contact Lens Seller Registration Act.  (Business and  
            Professions Code (BPC) § 2543)


          2)Under the Nonresident Contacts Lens Seller Registration Act,  








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            prohibits a person located outside California from shipping,  
            mailing, or delivering in any manner, contact lenses at retail  
            to a patient at a California address unless registered with  
            the Division of Licensing of the Medical Board of California,  
            and provides that only replacement contact lenses provided  
            pursuant to a valid prescription may be shipped, mailed, or  
            delivered directly to a patient.  (BPC § 2546.1)


          3)Defines a "trust" as a combination of capital, skill or acts  
            by two or more persons for specified purposes, including:


             a)   To fix at any standard or figure, whereby its price to  
               the public or consumer shall be in any manner controlled or  
               established, any article or commodity of merchandise,  
               produce or commerce intended for sale, barter, use or  
               consumption in this State.
             b)   To make or enter into or execute or carry out any  
               contracts, obligations or agreements of any kind or  
               description, by which they do all or any combination of the  
               following:


               i)     Bind them not to sell, dispose of or transport any  
                 article or any commodity or any article of trade, use,  
                 merchandise, commerce or consumption below a common  
                 standard figure, or fixed value.
               ii)Agree in any manner to keep the price of such article,  
                 commodity or transportation at a fixed or graduated  
                 figure.


               iii)Establish or settle the price of any article, commodity  
                 or transportation between them or themselves and others,  
                 so as directly or indirectly to preclude a free and  
                 unrestricted competition among themselves, or any  
                 purchasers or consumers in the sale or transportation of  
                 any such article or commodity.  (BPC Section 16720)








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          4)Makes every trust, subject to specified exemptions, unlawful,  
            against public policy, and void.  (BPC § 16726)    
          THIS BILL:


          5)Excludes a licensed physician and surgeon, licensed  
            optometrist, registered dispensing optician, or nonresident  
            contact lens seller from a manufacturer's unilateral pricing  
            policy or similar practice or agreement that purports to  
            establish a minimum advertised or selling price for contact  
            lenses.


          6)Raises the minimum fine for a violation of the Nonresident  
            Contact Lens Seller Registration Act from $1,000 to $1,500.  


          FISCAL EFFECT:  None.  This bill is keyed non-fiscal by the  
          Legislative Counsel.


          COMMENTS:


          Purpose.  This bill is sponsored by the author.   According to  
            the author, "Ensuring market competition is a fundamental  
            principle in our Capitalist society.  When market competition  
            is upheld and respected, consumers will almost always benefit  
            by the cost of a product decreasing due to the rivalry among  
            sellers to gain market share.  It is crucial that all who  
            participate in business activities in California uphold these  
            principles in order to not only protect consumers from over  
            spending on a given product unjustly, but also protecting  
            industries from unilateral price policies that create unfair  
            competition for businesses." 










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          Background.   Bausch + Lomb developed and distributed the first  
            soft contact lenses to eye care practitioners (ECPs) in the  
            United States in 1971.  At that time, it was common for an ECP  
            to perform an eye exam on a patient, fit contact lenses to the  
            patient's eyes and write a prescription for the contact lenses  
            that the patient would in turn purchase at their ECPs office.   
            By the late 1980's, contact lenses had grown in popularity and  
            new technology emerged including frequent replacement and  
            disposable contact lenses.  Today, there are approximately 35  
            million consumers in the U.S. that wear contact lenses.  These  
            consumers spend approximately $4.2 billion dollars annually on  
            the purchase of contact lenses.  Approximately 98 percent of  
            contact lenses are manufactured by four companies.  Ninety  
            percent of lenses are sold in ECPs offices and retail stores.   
            Ten percent of contact lenses are sold online.


          The Stark Act.  The introduction of the "Contact Lens  
            Prescription Act of 2001" (Stark Act) required ECPs to change  
            their practices and release a complete contact lens  
            prescription to their patients following the fitting process.   
            This act resulted in price competition among contact lens  
            retailers as patients were able to shop for their lenses.   
            Alternative methods of delivery, such as online retailers and  
            discount retailers, grew in popularity and subsequently drove  
            down contact lens prices making it difficult for private ECPs  
            to compete and remain profitable.


          UPPs.  A unilateral pricing policy (UPP) is when a manufacturer  
            unilaterally establishes a minimum sales price on their  
            products, and the development of that policy or its content is  
            made without agreement from retailers.  Under a UPP, a  
            manufacturer sets a minimum price below which the product  
            cannot be sold or advertised; a retailer may sell at a price  
            they wish, but if they choose to sell below the minimum price,  
            the manufacturer will no longer sell to the retailer. The  
            policy was first identified in United States v. Colgate & Co.,  
            250 U.S. 300 (1919).   








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          Resale Price Maintenance (RPM).  A RPM agreement is a contract  
            or agreement between the manufacturer and the retailer that  
            establishes the price at which the retailer can sell above  
            (minimum RPM) or below a price ceiling (maximum RPM).  For  
            nearly one hundred years, RPMs (also known as vertical price  
            fixing) were recognized as illegal under federal antitrust  
            laws.  However, in 2007, a U.S. Supreme Court decision, Leegin  
            Creative Leather Prods., Inc. v. PSKS, Inc., 551 U.S. 877  
            (2007), ruled that manufacturers should be allowed to have  
            more discretion in setting prices, and held that minimum  
            pricing policies could be legal under certain circumstances  
            and should be judged based on its actual effects on  
            competition.  While this decision opened up the possibility  
            that some RPMs may be legal,  California state law, under the  
            Cartwright Act, abrogates RPMs  .


          The Cartwright Act.  In California, the Cartwright Act  
            "prohibits the combination of resources of two or more  
            independent interests for the purpose of restraining commerce  
            and preventing market competition in the variety of ways  
            listed in the statute."  In essence, RPMs are prohibited  
            (Lowell v. Mother's Cake & Cookie Co. (1978) 79 Cal.App.3d  
            12).  However, "unilateral refusal by a producer to deal with  
            a distributor, absent proof that it was pursuant to an illegal  
            conspiracy, does not violate the antitrust laws" because  the  
            Cartwright Act only applies to a combination of two or more  
            persons  (Kolling v. Dow Jones & Co. (1982) 137 Cal.App.3d.  
            709).   As a result, if a seller acts unilaterally, e.g., by  
            establishing a UPP, that policy alone is not illegal.    


          Contact Lens Manufacturer's Impose UPPs.  There are four major  
            contact lens manufacturers who account for approximately 98  
            percent of contact lenses sold in the nation.  These  
            manufacturers are: 1) Johnson & Johnson Vision Care, 2) Bausch  
            + Lomb, 3) Alcon and 4) Cooper Vision.  According to the New  








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            York Times, over the last year and a half, all four  
            manufacturers have enacted UPPs, thereby setting minimum  
            retail prices for what contact lens retailers can charge for  
            certain products, and threatening to cut off supply if  
            retailers do not comply.  


          Proponents of these policies assert that these UPPs reduce  
            consumer prices for their contact lenses and increase pricing  
            transparency.  They believe that prescribers of contact lenses  
            can now focus more on patient vision needs than pricing and  
            rebates.  They cite studies that indicate the purchase of  
            contact lenses outside of an ECPs practice can increase the  
            risk of medical complications associated with contact lens  
            wear.  For example, Fogel and Zidile (2008) published results  
            of a survey of contact lens wearers and found that consumers  
            who purchased their contact lenses either online, or at a  
            vendor other than their ECP, were significantly less likely to  
            follow FDA-recommended contact lens care and wearing  
            behaviors.  A study conducted by Stapleton et al (2008) found  
            that those individuals who purchased their contact lenses over  
            the Internet were at approximately 4.8 times greater risk of  
            developing microbial keratitis compared to patients who  
            purchased their lenses at their ECP's office.


          Opponents assert that these policies are anti-competitive and  
            amount to illegal price-fixing, and restrict consumer choices.  
             They indicate that the manufacturers are more interested in  
            serving the needs of ECPs versus the needs of patients.  For  
            example, opponents cite an article in Vision Monday in which  
            the President of Johnson & Johnson Vision Care, North America,  
            stated, "[UPP] is a holistic multifaceted pricing policy to  
            refocus the conversation between the doctor and the patient on  
            eye health and product performance rather than price.   This  
            gives the optometrist the ability to improve his or her  
            capture rate in the office  ?  Now the patient has no incentive to  
            shop around  ."









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          Congressional Hearings. In August of 2014, the U.S. Senate  
            Judiciary Committee's antitrust panel met to consider whether  
            decisions by Johnson & Johnson Vision Care, Alcon and Bausch +  
            Lomb, to institute UPPs for some of their products,  
            constitutes anticompetitive behavior by limiting competition  
            and possibly resulting in higher prices.  Senator Klobuchar  
            remarked, 


          This is intended as an exploratory hearing.  More than 35  
            million Americans use contact lenses. Tens of millions of  
            consumers pay for contact lenses each year; price matters.   
            Some consumers wear lenses longer than they should.  Price can  
            impact this? As I understand it the market for contact lenses  
            is different than other markets. The retailer of the product  
            is a kind of essential gatekeeper.  Without his involvement or  
            RX, [this] might impact the sale of the products.  Three  
            manufacturers have announced pricing [plans] whereby there are  
            minimum price agreements?In some instances, [such] agreements  
            can be justified.   But in most cases the most immediate  
            results is an increase in price, as the consumer can no longer  
            seek the product at a lower price.  


          The three major retailers testified and indicated that UPPs were  
            created with the needs of consumers in mind.  The matter is  
            now pending investigation by the Federal Trade Commission.


          Other States.  According to the author, several states are  
            pursuing legislation to ban the use of UPPs for contact lenses  
            in their state including: Oregon, Idaho, Arizona, Minnesota,  
            Florida, New York, Illinois and Louisiana.  In March of 2015,  
            Utah successfully passed a law banning UPPs for contact  
            lenses.  In response, Johnson & Johnson Vision Care, Bausch +  
            Lomb and Alcon filed lawsuits to stop Utah's attorney general  
            from enforcing the new law.  The litigation is still pending.   
            There is also a cadre of pending class action lawsuits against  








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            manufacturers for imposing UPPs on retailers.


          Prior Related Legislation.   AB 2020 (Correa) Chapter 814,  
            Statutes of 2002, requires optometrists and ophthalmologists  
            (prescribers) and registered dispensing optician to            
            provide a patient with a copy of his or her contact lens  
            prescription, with certain exceptions, specifies the  
            requirements of an expiration date on a prescription, and  
            requires that out-of-state sellers of contact lenses must  
            attempt to verify the prescription with the prescriber, under   
                   specified conditions.


          SB 640 (Craven) Chapter 853, Statutes of 1995, prohibited any  
            person located outside of California from shipping, mailing,  
            or delivering contact lenses to residents of California unless  
            registered with the Division of Licensing of the Medical Board  
            of California, and provided that only replacement lenses may  
            be shipped, mailed, or delivered to a patient.


          ARGUMENTS IN SUPPORT: 


          The  California Retailers Association  supports the measure and  
          writes, "Under AB 789, our members will be able to offer  
          affordable prices on contact lenses which provides consumers  
          with more choice, convenience and increased access to these  
          products.  Additionally, by allowing retailers to offer discount  
          prices on contact lenses, consumers may experience a reduction  
          in their out of network costs for contact lenses?AB 789 creates  
          an open market which allows consumer choice to drive profits."


           Consumers Union  also supports the bill and writes, "This  
          legislation will restore a fair opportunity for consumers to  
          shop for contact lenses at more affordable prices."









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          ARGUMENTS IN OPPOSITION:


          The  California Optometric Association  opposes the bill and  
          writes, "COA opposes AB 789 because it's bad for patients.   
          Studies have shown that patients have less lens-related  
          complications when they get contact lenses from their local  
          optometrist versus online merchants."


           Johnson & Johnson Vision Care  also opposes the bill and writes,  
          "In the summer of 2014, JJVCI concluded an exhaustive analysis  
          of its business and determined that many of its best-selling  
          contact lenses were priced too high to consumers relative to  
          other products in the market.  While JJVCI does not sell its  
          lenses directly to consumers it embarked on a comprehensive plan  
          designed to lower prices for the overwhelming majority of  
          consumers.  AB 789 is focused on one industry, which goes  
          against the overwhelming trend in antitrust law of keeping  
          antitrust general and avoiding industry-specific rules.  If  
          passed, the precedent the policy would have for other industries  
          is significant." 


          In a joint letter, the  Advanced Medical Technology Association  ,  
           Biocom  ,  Biotechnology Industry Organization  ,  California  
          Healthcare Institute  and the  California Manufacturers &  
          Technology Association  write, "UPPs generally increase service  
          levels, increase choice, provide pricing transparency, increase  
          innovation, strengthen competition between manufacturers, and  
          can lower consumer prices?By targeting only one industry, this  
          bill is counter to the overwhelming trend that has led to  
          general antitrust laws which seek to avoid industry-specific  
          rules?Also of note, this measure violates the Commerce Clause as  
          it attempts to regulate sales that occur wholly outside of  
          California."










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          POLICY ISSUE FOR CONSIDERATION:


          This measure seeks to ban the practice of a manufacturer  
          establishing a UPP for the sale of contact lenses in California.  
           In consideration of the pending court cases regarding the  
          implementation of UPPs, and the investigation by the Federal  
          Trade Commission, this measure may be premature.  The Committee  
          may wish to consider waiting for the outcome of the litigation  
          before passing a bill that may ban a practice of which the  
          legality is being examined by state courts and the Federal Trade  
          Commission. 


          AMENDMENTS:


          In the interest of consumers, the Committee may wish to consider  
            amendments that would enable a consumer to purchase contact  
            lenses at a competitive price.  The UPPs that manufacturers  
            have created for some products specify that the product may  
            not be sold below the UPP.  Retailers that would like to  
            provide a rebate to customers are only able to offer the  
            rebate if the rebate does not result in the product being sold  
            below the UPP set by the manufacturer-making the rebate offer  
            less useful and attractive to consumers.  The author should  
            consider an amendment that specifies that a manufacturer's UPP  
            should not be inclusive of rebates offered by the retailer.   
            Additionally,  it may be prudent to impose a sunset date in  
            consideration of the ongoing litigation and Federal Trade  
            Commission investigation as outlined below:


          7)On page 2, strike lines 3-10 inclusive.
          8)On page 2, on line 3, insert: (a)  Until January 1, 2019, if a  
            contact lens manufacturer imposes a pricing policy, practice  
            or agreement that establishes a minimum advertised or selling  
            price for contact lens sellers, a licensed physician and  
            surgeon, licensed optometrist, registered dispensing optician,  








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            or nonresident contact lens seller may sell contact lenses  
            below that price to account for the rebates offered by the  
            retailer.    


           9)(b) This section shall not be construed as authorizing minimum  
            price agreements between contact lens manufacturers and  
            contact lens retailers under Chapter 2 (commencing with  
            Section 16700) of Division 7.


           10)On page 3, strike lines 30-40, inclusive.


          11)On page 4, strike lines 1-7, inclusive.


          REGISTERED SUPPORT:  


          California Retailers Association


          Consumers Union




          REGISTERED OPPOSITION:  
          Advanced Medical Technology Association 


          Biocom


          Biotechnology Industry Organization


          California Healthcare Institute








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          California Manufacturers & Technology Association


          California Optometric Association


          Johnson & Johnson Vision Care




          Analysis Prepared by:Le Ondra Clark Harvey, Ph.D. / B. & P. /  
          (916) 319-3301